Trial Outcomes & Findings for Study of CLAG + Selinexor in Relapsed or Refractory Acute Myeloid Leukemia (NCT NCT02416908)
NCT ID: NCT02416908
Last Updated: 2020-03-13
Results Overview
-All adverse events will be classified using the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
40 participants
Primary outcome timeframe
From start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever came first (41 days)
Results posted on
2020-03-13
Participant Flow
The study was opened to allow participant enrollment on 06/16/2015 and the study was closed to participant enrollment on 01/22/2018.
* Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data * Maintenance Phase patients are patients who were enrolled \& treated in Phase I Schedule A or Phase II but met certain criteria to receive maintenance selinexor. Their data will only be included in adverse event results.
Participant milestones
| Measure |
Phase I Schedule A (Selinexor)
* Selinexor will be dosed on Days 1, 5, 10, and 12 of the 28-day cycle. All doses will be 60 mg each PO.
* Single agent selinexor maintenance may be given at 60 mg on Days 1, 8, 15, and 22 (4 doses per 28 day cycle).
* Cladribine will be given 5 mg/m\^2/day IV once daily on Days 4-8.
* G-CSF will be given 300 mcg SC once daily on Days 3-8.
* Cytarabine will be given 2000 mg/m\^2/day IV once daily on Days 4-8.
* Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response.
|
Phase I Schedule B (Selinexor)
* Selinexor will be dosed on Days 1, 5, 10, 12, 17, and 19 of the 28-day cycle. All doses will be 60 mg each PO.
* Single agent selinexor maintenance may be given at 60 mg on Days 1, 8, 15, and 22 (4 doses per 28 day cycle).
* Cladribine will be given 5 mg/m\^2/day IV once daily on Days 4-8.
* G-CSF will be given 300 mcg SC once daily on Days 3-8.
* Cytarabine will be given 2000 mg/m\^2/day IV once daily on Days 4-8.
* Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response.
|
Phase II (Selinexor)
* Selinexor will be given at the schedule as determined in Phase 1.
* Single agent selinexor maintenance may be given at 60 mg on Days 1, 8, 15, and 22 (4 doses per 28 day cycle).
* Cladribine will be given 5 mg/m\^2/day IV once daily on Days 4-8.
* G-CSF will be given 300 mcg SC once daily on Days 3-8.
* Cytarabine will be given 2000 mg/m\^2/day IV once daily on Days 4-8.
* Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response.
|
Selinexor Maintenance Phase (Optional)
* These patients were enrolled and treated in the Phase I Schedule A Arm or the Phase II Arm and if they met the requirements below then they were able to receive maintenance selinexor
* Available for patients who have achieved a CR or CRi based on post-treatment bone marrow assessment at the time of hematopoietic recovery and are either (1) transplant ineligible or (2) do not have a stem cell transplant donor available
* 60 mg selinexor on Days 1, 8, 15, and 22 of a 28-day cycle
|
|---|---|---|---|---|
|
Dose Escalation Phase
STARTED
|
6
|
0
|
34
|
0
|
|
Dose Escalation Phase
COMPLETED
|
6
|
0
|
30
|
0
|
|
Dose Escalation Phase
NOT COMPLETED
|
0
|
0
|
4
|
0
|
|
Maintenance Phase
STARTED
|
0
|
0
|
0
|
2
|
|
Maintenance Phase
COMPLETED
|
0
|
0
|
0
|
2
|
|
Maintenance Phase
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Phase I Schedule A (Selinexor)
* Selinexor will be dosed on Days 1, 5, 10, and 12 of the 28-day cycle. All doses will be 60 mg each PO.
* Single agent selinexor maintenance may be given at 60 mg on Days 1, 8, 15, and 22 (4 doses per 28 day cycle).
* Cladribine will be given 5 mg/m\^2/day IV once daily on Days 4-8.
* G-CSF will be given 300 mcg SC once daily on Days 3-8.
* Cytarabine will be given 2000 mg/m\^2/day IV once daily on Days 4-8.
* Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response.
|
Phase I Schedule B (Selinexor)
* Selinexor will be dosed on Days 1, 5, 10, 12, 17, and 19 of the 28-day cycle. All doses will be 60 mg each PO.
* Single agent selinexor maintenance may be given at 60 mg on Days 1, 8, 15, and 22 (4 doses per 28 day cycle).
* Cladribine will be given 5 mg/m\^2/day IV once daily on Days 4-8.
* G-CSF will be given 300 mcg SC once daily on Days 3-8.
* Cytarabine will be given 2000 mg/m\^2/day IV once daily on Days 4-8.
* Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response.
|
Phase II (Selinexor)
* Selinexor will be given at the schedule as determined in Phase 1.
* Single agent selinexor maintenance may be given at 60 mg on Days 1, 8, 15, and 22 (4 doses per 28 day cycle).
* Cladribine will be given 5 mg/m\^2/day IV once daily on Days 4-8.
* G-CSF will be given 300 mcg SC once daily on Days 3-8.
* Cytarabine will be given 2000 mg/m\^2/day IV once daily on Days 4-8.
* Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response.
|
Selinexor Maintenance Phase (Optional)
* These patients were enrolled and treated in the Phase I Schedule A Arm or the Phase II Arm and if they met the requirements below then they were able to receive maintenance selinexor
* Available for patients who have achieved a CR or CRi based on post-treatment bone marrow assessment at the time of hematopoietic recovery and are either (1) transplant ineligible or (2) do not have a stem cell transplant donor available
* 60 mg selinexor on Days 1, 8, 15, and 22 of a 28-day cycle
|
|---|---|---|---|---|
|
Dose Escalation Phase
Adverse Event
|
0
|
0
|
3
|
0
|
|
Dose Escalation Phase
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study of CLAG + Selinexor in Relapsed or Refractory Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Phase I Schedule A (Selinexor)
n=6 Participants
* Selinexor will be dosed on Days 1, 5, 10, and 12 of the 28-day cycle. All doses will be 60 mg each PO.
* Single agent selinexor maintenance may be given at 60 mg on Days 1, 8, 15, and 22 (4 doses per 28 day cycle).
* Cladribine will be given 5 mg/m\^2/day IV once daily on Days 4-8.
* G-CSF will be given 300 mcg SC once daily on Days 3-8.
* Cytarabine will be given 2000 mg/m\^2/day IV once daily on Days 4-8.
* Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response.
|
Phase I Schedule B (Selinexor)
* Selinexor will be dosed on Days 1, 5, 10, 12, 17, and 19 of the 28-day cycle. All doses will be 60 mg each PO.
* Single agent selinexor maintenance may be given at 60 mg on Days 1, 8, 15, and 22 (4 doses per 28 day cycle).
* Cladribine will be given 5 mg/m\^2/day IV once daily on Days 4-8.
* G-CSF will be given 300 mcg SC once daily on Days 3-8.
* Cytarabine will be given 2000 mg/m\^2/day IV once daily on Days 4-8.
* Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response.
|
Phase II (Selinexor)
n=34 Participants
* Selinexor will be given at the schedule as determined in Phase 1.
* Single agent selinexor maintenance may be given at 60 mg on Days 1, 8, 15, and 22 (4 doses per 28 day cycle).
* Cladribine will be given 5 mg/m\^2/day IV once daily on Days 4-8.
* G-CSF will be given 300 mcg SC once daily on Days 3-8.
* Cytarabine will be given 2000 mg/m\^2/day IV once daily on Days 4-8.
* Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.5 years
n=39 Participants
|
—
|
55 years
n=35 Participants
|
55.5 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=39 Participants
|
—
|
13 Participants
n=35 Participants
|
15 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=39 Participants
|
—
|
21 Participants
n=35 Participants
|
25 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
—
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=39 Participants
|
—
|
34 Participants
n=35 Participants
|
40 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
—
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
—
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
—
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
—
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
—
|
2 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=39 Participants
|
—
|
32 Participants
n=35 Participants
|
38 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
—
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
—
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=39 Participants
|
—
|
34 participants
n=35 Participants
|
40 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: From start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever came first (41 days)Population: -Phase I Schedule A Arm and Phase II Arm data was combined as all participants received the same dose and schedule of the study regimen.
-All adverse events will be classified using the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Outcome measures
| Measure |
Phase I Schedule A and Phase II
n=40 Participants
* Selinexor will be dosed on Days 1, 5, 10, and 12 of the 28-day cycle. All doses will be 60 mg each PO.
* Cladribine will be given 5 mg/m\^2/day IV once daily on Days 4-8.
* G-CSF will be given 300 mcg SC once daily on Days 3-8.
* Cytarabine will be given 2000 mg/m\^2/day IV once daily on Days 4-8.
* Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response.
|
|---|---|
|
Safety and Tolerability of Treatment as Measured by Incidence of Grade 3-4 Adverse Events Occurring in >5% of Participants
Diarrhea
|
3 Participants
|
|
Safety and Tolerability of Treatment as Measured by Incidence of Grade 3-4 Adverse Events Occurring in >5% of Participants
Lymphocyte count decreased
|
32 Participants
|
|
Safety and Tolerability of Treatment as Measured by Incidence of Grade 3-4 Adverse Events Occurring in >5% of Participants
White blood cell decreased
|
28 Participants
|
|
Safety and Tolerability of Treatment as Measured by Incidence of Grade 3-4 Adverse Events Occurring in >5% of Participants
Hypophosphatemia
|
26 Participants
|
|
Safety and Tolerability of Treatment as Measured by Incidence of Grade 3-4 Adverse Events Occurring in >5% of Participants
Platelet count decreased
|
22 Participants
|
|
Safety and Tolerability of Treatment as Measured by Incidence of Grade 3-4 Adverse Events Occurring in >5% of Participants
Neutrophil count decreased
|
21 Participants
|
|
Safety and Tolerability of Treatment as Measured by Incidence of Grade 3-4 Adverse Events Occurring in >5% of Participants
Hyponatremia
|
18 Participants
|
|
Safety and Tolerability of Treatment as Measured by Incidence of Grade 3-4 Adverse Events Occurring in >5% of Participants
Anemia
|
14 Participants
|
|
Safety and Tolerability of Treatment as Measured by Incidence of Grade 3-4 Adverse Events Occurring in >5% of Participants
Hyperglycemia
|
11 Participants
|
|
Safety and Tolerability of Treatment as Measured by Incidence of Grade 3-4 Adverse Events Occurring in >5% of Participants
Skin infection
|
10 Participants
|
|
Safety and Tolerability of Treatment as Measured by Incidence of Grade 3-4 Adverse Events Occurring in >5% of Participants
Febrile neutropenia
|
8 Participants
|
|
Safety and Tolerability of Treatment as Measured by Incidence of Grade 3-4 Adverse Events Occurring in >5% of Participants
Sepsis
|
8 Participants
|
|
Safety and Tolerability of Treatment as Measured by Incidence of Grade 3-4 Adverse Events Occurring in >5% of Participants
Hypokalemia
|
8 Participants
|
|
Safety and Tolerability of Treatment as Measured by Incidence of Grade 3-4 Adverse Events Occurring in >5% of Participants
Lung infection
|
7 Participants
|
|
Safety and Tolerability of Treatment as Measured by Incidence of Grade 3-4 Adverse Events Occurring in >5% of Participants
Alanine aminotransferase increased
|
5 Participants
|
|
Safety and Tolerability of Treatment as Measured by Incidence of Grade 3-4 Adverse Events Occurring in >5% of Participants
Oral thrush
|
4 Participants
|
|
Safety and Tolerability of Treatment as Measured by Incidence of Grade 3-4 Adverse Events Occurring in >5% of Participants
Hypoxia
|
4 Participants
|
|
Safety and Tolerability of Treatment as Measured by Incidence of Grade 3-4 Adverse Events Occurring in >5% of Participants
Hypertension
|
4 Participants
|
|
Safety and Tolerability of Treatment as Measured by Incidence of Grade 3-4 Adverse Events Occurring in >5% of Participants
Nausea
|
3 Participants
|
|
Safety and Tolerability of Treatment as Measured by Incidence of Grade 3-4 Adverse Events Occurring in >5% of Participants
Edema limbs
|
3 Participants
|
|
Safety and Tolerability of Treatment as Measured by Incidence of Grade 3-4 Adverse Events Occurring in >5% of Participants
Catheter-related infection
|
3 Participants
|
|
Safety and Tolerability of Treatment as Measured by Incidence of Grade 3-4 Adverse Events Occurring in >5% of Participants
Hematuria
|
3 Participants
|
|
Safety and Tolerability of Treatment as Measured by Incidence of Grade 3-4 Adverse Events Occurring in >5% of Participants
Respiratory failure
|
3 Participants
|
PRIMARY outcome
Timeframe: Median follow-up of 34 daysPopulation: -Phase I Schedule A Arm and Phase II Arm data was combined as all participants received the same dose and schedule of the study regimen.
* Morphologic complete remission (CR): neutrophil count \> 1.0 x 109 /L, platelet count ≥ 100 x 109/L, \< 5% bone marrow blasts by morphologic review, no Auer rods, no evidence of extramedullary disease. (No requirements for marrow cellularity, hemoglobin concentration). * Morphologic complete remission with incomplete blood count recovery (CRi): same as CR but ANC may be \<1000/mcl or platelet count \<100,000/mcl * Participants in the phase I portion of the study, treated at the MTD will count towards the phase II accrual goal for evaluation of the primary endpoint.
Outcome measures
| Measure |
Phase I Schedule A and Phase II
n=40 Participants
* Selinexor will be dosed on Days 1, 5, 10, and 12 of the 28-day cycle. All doses will be 60 mg each PO.
* Cladribine will be given 5 mg/m\^2/day IV once daily on Days 4-8.
* G-CSF will be given 300 mcg SC once daily on Days 3-8.
* Cytarabine will be given 2000 mg/m\^2/day IV once daily on Days 4-8.
* Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response.
|
|---|---|
|
Complete Remission Rate (CR + CRi)
|
18 Participants
|
SECONDARY outcome
Timeframe: 56 daysPopulation: -Phase I Schedule A Arm and Phase II Arm data was combined as all participants received the same dose and schedule of the study regimen.
-Time to platelet engraftment: Defined as the date of the first dose of study drug to the date that the platelet count is \>100,000/mm\^3 in the absence of platelet transfusions.
Outcome measures
| Measure |
Phase I Schedule A and Phase II
n=40 Participants
* Selinexor will be dosed on Days 1, 5, 10, and 12 of the 28-day cycle. All doses will be 60 mg each PO.
* Cladribine will be given 5 mg/m\^2/day IV once daily on Days 4-8.
* G-CSF will be given 300 mcg SC once daily on Days 3-8.
* Cytarabine will be given 2000 mg/m\^2/day IV once daily on Days 4-8.
* Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response.
|
|---|---|
|
Time to Platelet Engraftment
|
38 days
Interval 29.0 to 61.0
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: -Phase I Schedule A Arm and Phase II Arm data was combined as all participants received the same dose and schedule of the study regimen.
-Time to neutrophil engraftment: Defined as the date of the first dose of study drug to the date that the absolute neutrophil count is \>1,000/mm3
Outcome measures
| Measure |
Phase I Schedule A and Phase II
n=40 Participants
* Selinexor will be dosed on Days 1, 5, 10, and 12 of the 28-day cycle. All doses will be 60 mg each PO.
* Cladribine will be given 5 mg/m\^2/day IV once daily on Days 4-8.
* G-CSF will be given 300 mcg SC once daily on Days 3-8.
* Cytarabine will be given 2000 mg/m\^2/day IV once daily on Days 4-8.
* Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response.
|
|---|---|
|
Time to Neutrophil Engraftment
|
28 days
Interval 24.0 to 58.0
|
SECONDARY outcome
Timeframe: Up to 2 years (median follow-up of 307 days)Population: -Phase I Schedule A Arm and Phase II Arm data was combined as all participants received the same dose and schedule of the study regimen.
Event-free survival (EFS): Defined as the interval from the date of first dose of study drug to date of treatment failure including progressive disease, recurrence, or discontinuation for any reason (including toxicity, patient preference, initiation of new treatment without documented progression, or death due to any cause).
Outcome measures
| Measure |
Phase I Schedule A and Phase II
n=40 Participants
* Selinexor will be dosed on Days 1, 5, 10, and 12 of the 28-day cycle. All doses will be 60 mg each PO.
* Cladribine will be given 5 mg/m\^2/day IV once daily on Days 4-8.
* G-CSF will be given 300 mcg SC once daily on Days 3-8.
* Cytarabine will be given 2000 mg/m\^2/day IV once daily on Days 4-8.
* Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response.
|
|---|---|
|
Event-free Survival
|
6.1 months
Interval 4.5 to 7.8
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: -Phase I Schedule A Arm and Phase II Arm data was combined as all participants received the same dose and schedule of the study regimen.
-Duration of remission (DOR): Defined as the interval from the date complete remission is documented to the date of recurrence.
Outcome measures
| Measure |
Phase I Schedule A and Phase II
n=40 Participants
* Selinexor will be dosed on Days 1, 5, 10, and 12 of the 28-day cycle. All doses will be 60 mg each PO.
* Cladribine will be given 5 mg/m\^2/day IV once daily on Days 4-8.
* G-CSF will be given 300 mcg SC once daily on Days 3-8.
* Cytarabine will be given 2000 mg/m\^2/day IV once daily on Days 4-8.
* Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response.
|
|---|---|
|
Duration of Remission
|
9.1 months
Interval 1.9 to
Upper confidence interval not yet reached.
|
SECONDARY outcome
Timeframe: Median follow-up of 307 daysPopulation: -Phase I Schedule A Arm and Phase II Arm data was combined as all participants received the same dose and schedule of the study regimen.
Relapse-free survival (RFS): For patients achieving a complete remission, defined as the interval from the date of first documentation of a leukemia free state to date of recurrence or death due to any cause.
Outcome measures
| Measure |
Phase I Schedule A and Phase II
n=18 Participants
* Selinexor will be dosed on Days 1, 5, 10, and 12 of the 28-day cycle. All doses will be 60 mg each PO.
* Cladribine will be given 5 mg/m\^2/day IV once daily on Days 4-8.
* G-CSF will be given 300 mcg SC once daily on Days 3-8.
* Cytarabine will be given 2000 mg/m\^2/day IV once daily on Days 4-8.
* Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response.
|
|---|---|
|
Relapse-free Survival
|
152 days
Interval 6.0 to 730.0
|
SECONDARY outcome
Timeframe: Up to 2 years (median follow-up of 307 days)Population: -Phase I Schedule A Arm and Phase II Arm data was combined as all participants received the same dose and schedule of the study regimen.
Overall survival (OS): Defined as the date of first dose of study drug to the date of death from any cause. OS will be evaluated at 3 month intervals for at least 12 months and up to a maximum of 2 years.
Outcome measures
| Measure |
Phase I Schedule A and Phase II
n=40 Participants
* Selinexor will be dosed on Days 1, 5, 10, and 12 of the 28-day cycle. All doses will be 60 mg each PO.
* Cladribine will be given 5 mg/m\^2/day IV once daily on Days 4-8.
* G-CSF will be given 300 mcg SC once daily on Days 3-8.
* Cytarabine will be given 2000 mg/m\^2/day IV once daily on Days 4-8.
* Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response.
|
|---|---|
|
Overall Survival
|
7.8 months
Interval 5.7 to 14.1
|
SECONDARY outcome
Timeframe: Up to 2 years (median follow-up of 307 days)Population: -Phase I Schedule A Arm and Phase II Arm data was combined as all participants received the same dose and schedule of the study regimen.
Allogeneic stem cell transplant utilization: the number of patients proceeding to allogeneic transplant within 2 months following end of study without any additional salvage therapy following study treatment.
Outcome measures
| Measure |
Phase I Schedule A and Phase II
n=40 Participants
* Selinexor will be dosed on Days 1, 5, 10, and 12 of the 28-day cycle. All doses will be 60 mg each PO.
* Cladribine will be given 5 mg/m\^2/day IV once daily on Days 4-8.
* G-CSF will be given 300 mcg SC once daily on Days 3-8.
* Cytarabine will be given 2000 mg/m\^2/day IV once daily on Days 4-8.
* Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response.
|
|---|---|
|
Number of Participants Who Were Able to Undergo Hematopoietic Stem Cell Transplantation
|
24 Participants
|
Adverse Events
Phase I Schedule A (Selinexor)
Serious events: 4 serious events
Other events: 6 other events
Deaths: 5 deaths
Phase I Schedule B (Selinexor)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase II (Selinexor)
Serious events: 14 serious events
Other events: 34 other events
Deaths: 25 deaths
Selinexor Maintenance Phase (Optional)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Phase I Schedule A (Selinexor)
n=6 participants at risk
* Selinexor will be dosed on Days 1, 5, 10, and 12 of the 28-day cycle. All doses will be 60 mg each PO.
* Single agent selinexor maintenance may be given at 60 mg on Days 1, 8, 15, and 22 (4 doses per 28 day cycle).
* Cladribine will be given 5 mg/m\^2/day IV once daily on Days 4-8.
* G-CSF will be given 300 mcg SC once daily on Days 3-8.
* Cytarabine will be given 2000 mg/m\^2/day IV once daily on Days 4-8.
* Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response.
|
Phase I Schedule B (Selinexor)
* Selinexor will be dosed on Days 1, 5, 10, 12, 17, and 19 of the 28-day cycle. All doses will be 60 mg each PO.
* Single agent selinexor maintenance may be given at 60 mg on Days 1, 8, 15, and 22 (4 doses per 28 day cycle).
* Cladribine will be given 5 mg/m\^2/day IV once daily on Days 4-8.
* G-CSF will be given 300 mcg SC once daily on Days 3-8.
* Cytarabine will be given 2000 mg/m\^2/day IV once daily on Days 4-8.
* Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response.
|
Phase II (Selinexor)
n=34 participants at risk
* Selinexor will be given at the schedule as determined in Phase 1.
* Single agent selinexor maintenance may be given at 60 mg on Days 1, 8, 15, and 22 (4 doses per 28 day cycle).
* Cladribine will be given 5 mg/m\^2/day IV once daily on Days 4-8.
* G-CSF will be given 300 mcg SC once daily on Days 3-8.
* Cytarabine will be given 2000 mg/m\^2/day IV once daily on Days 4-8.
* Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response.
|
Selinexor Maintenance Phase (Optional)
n=2 participants at risk
* Available for patients who have achieved a CR or CRi based on post-treatment bone marrow assessment at the time of hematopoietic recovery and are either (1) transplant ineligible or (2) do not have a stem cell transplant donor available
* 60 mg selinexor on Days 1, 8, 15, and 22 of a 28-day cycle
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Cardiac disorders
Constrictive pericarditis
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
General disorders
Fever
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Infections and infestations
Bone infection
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
50.0%
1/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Infections and infestations
Lung infection
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Infections and infestations
Sepsis
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
20.6%
7/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
50.0%
1/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Nervous system disorders
Seizure
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
Other adverse events
| Measure |
Phase I Schedule A (Selinexor)
n=6 participants at risk
* Selinexor will be dosed on Days 1, 5, 10, and 12 of the 28-day cycle. All doses will be 60 mg each PO.
* Single agent selinexor maintenance may be given at 60 mg on Days 1, 8, 15, and 22 (4 doses per 28 day cycle).
* Cladribine will be given 5 mg/m\^2/day IV once daily on Days 4-8.
* G-CSF will be given 300 mcg SC once daily on Days 3-8.
* Cytarabine will be given 2000 mg/m\^2/day IV once daily on Days 4-8.
* Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response.
|
Phase I Schedule B (Selinexor)
* Selinexor will be dosed on Days 1, 5, 10, 12, 17, and 19 of the 28-day cycle. All doses will be 60 mg each PO.
* Single agent selinexor maintenance may be given at 60 mg on Days 1, 8, 15, and 22 (4 doses per 28 day cycle).
* Cladribine will be given 5 mg/m\^2/day IV once daily on Days 4-8.
* G-CSF will be given 300 mcg SC once daily on Days 3-8.
* Cytarabine will be given 2000 mg/m\^2/day IV once daily on Days 4-8.
* Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response.
|
Phase II (Selinexor)
n=34 participants at risk
* Selinexor will be given at the schedule as determined in Phase 1.
* Single agent selinexor maintenance may be given at 60 mg on Days 1, 8, 15, and 22 (4 doses per 28 day cycle).
* Cladribine will be given 5 mg/m\^2/day IV once daily on Days 4-8.
* G-CSF will be given 300 mcg SC once daily on Days 3-8.
* Cytarabine will be given 2000 mg/m\^2/day IV once daily on Days 4-8.
* Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response.
|
Selinexor Maintenance Phase (Optional)
n=2 participants at risk
* Available for patients who have achieved a CR or CRi based on post-treatment bone marrow assessment at the time of hematopoietic recovery and are either (1) transplant ineligible or (2) do not have a stem cell transplant donor available
* 60 mg selinexor on Days 1, 8, 15, and 22 of a 28-day cycle
|
|---|---|---|---|---|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Infections and infestations
Skin infection
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
29.4%
10/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
5.9%
2/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Injury, poisoning and procedural complications
Bleeding at bone marrow biopsy site
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Injury, poisoning and procedural complications
Bruising
|
33.3%
2/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
8.8%
3/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Injury, poisoning and procedural complications
Fall
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
14.7%
5/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
17.6%
6/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Investigations
Alanine aminotransferase increased
|
100.0%
6/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
50.0%
17/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Investigations
Alkaline phosphatase increased
|
50.0%
3/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
55.9%
19/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Investigations
Aspartate aminotransferase increased
|
83.3%
5/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
58.8%
20/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
50.0%
1/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Investigations
Blood bilirubin increased
|
33.3%
2/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
50.0%
17/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Investigations
Creatinine increased
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
8.8%
3/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Investigations
INR increased
|
50.0%
3/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
58.8%
20/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Investigations
Lymphocyte count decreased
|
83.3%
5/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
94.1%
32/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Investigations
Neutrophil count decreased
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
61.8%
21/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
100.0%
2/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Investigations
Platelet count decreased
|
50.0%
3/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
64.7%
22/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
100.0%
2/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Investigations
Weight gain
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Investigations
Weight loss
|
83.3%
5/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
50.0%
17/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Investigations
White blood cell decreased
|
50.0%
3/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
82.4%
28/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
100.0%
2/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
2/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
8.8%
3/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
5.9%
2/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
32.4%
11/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
41.2%
14/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
50.0%
1/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
66.7%
4/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
41.2%
14/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
17.6%
6/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
83.3%
5/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
61.8%
21/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
50.0%
3/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
91.2%
31/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
14.7%
5/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
66.7%
4/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
58.8%
20/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
14.7%
5/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
100.0%
6/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
97.1%
33/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
50.0%
1/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
33.3%
2/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
88.2%
30/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Musculoskeletal and connective tissue disorders
Age indeterminant spinal stress fracture
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
11.8%
4/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
5.9%
2/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
33.3%
2/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
14.7%
5/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Musculoskeletal and connective tissue disorders
Jaw pain
|
33.3%
2/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
5.9%
2/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Musculoskeletal and connective tissue disorders
Worsening pain-hip/knees/legs
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
17.6%
6/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
50.0%
1/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Nervous system disorders
Encephalopathy
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
17.6%
6/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Nervous system disorders
Lethargy
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Nervous system disorders
Paresthesia
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
5.9%
2/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Nervous system disorders
Reversible posterior leukoencephalopathy syndrome
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
17.6%
6/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Psychiatric disorders
Altered mental status
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
23.5%
8/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Psychiatric disorders
Delirium
|
33.3%
2/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Psychiatric disorders
Depression
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
5.9%
2/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
11.8%
4/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Renal and urinary disorders
Acute kidney injury
|
33.3%
2/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
14.7%
5/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Renal and urinary disorders
Hematuria
|
33.3%
2/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
38.2%
13/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Renal and urinary disorders
Proteinuria
|
33.3%
2/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
52.9%
18/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
5.9%
2/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Renal and urinary disorders
Urine output decreased
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
5.9%
2/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Reproductive system and breast disorders
Genital edema
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
5.9%
2/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
33.3%
2/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
20.6%
7/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
11.8%
4/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
5.9%
2/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
17.6%
6/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
20.6%
7/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
14.7%
5/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
33.3%
2/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
23.5%
8/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
11.8%
4/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
5.9%
2/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
5.9%
2/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
50.0%
1/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
17.6%
6/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Skin and subcutaneous tissue disorders
Lipoma
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Skin and subcutaneous tissue disorders
Nasal lesion
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
8.8%
3/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Skin and subcutaneous tissue disorders
Perianal lesion
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
17.6%
6/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Skin and subcutaneous tissue disorders
Skin abrasion
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
5.9%
2/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Skin and subcutaneous tissue disorders
Sweet's syndrome
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Vascular disorders
Hematoma
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
5.9%
2/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
11.8%
4/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Vascular disorders
Hypotension
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
20.6%
7/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Vascular disorders
Thromboembolic event
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
5.9%
2/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
50.0%
1/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
2/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
41.2%
14/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
23.5%
8/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Cardiac disorders
Atrial fibrillation
|
33.3%
2/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Cardiac disorders
Pericardial effusion
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Cardiac disorders
Sinus brachycardia
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
23.5%
8/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Cardiac disorders
Sinus tachycardia
|
33.3%
2/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
32.4%
11/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Cardiac disorders
Supraventricular tachycardia
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
5.9%
2/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Ear and labyrinth disorders
Ear pain
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Ear and labyrinth disorders
External ear inflammation
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Eye disorders
Blurred vision
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
5.9%
2/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Eye disorders
Glaucoma
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Eye disorders
Intraretinal hemorrhage
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Eye disorders
Photophobia
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Eye disorders
Vision changes-acuity
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
2/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
5.9%
2/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
35.3%
12/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
4/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
41.2%
14/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
50.0%
1/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
5.9%
2/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Gastrointestinal disorders
Dysphagia
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Gastrointestinal disorders
Hematemesis
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
5.9%
2/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Gastrointestinal disorders
Mucositis oral
|
83.3%
5/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
61.8%
21/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Gastrointestinal disorders
Nausea
|
83.3%
5/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
52.9%
18/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
50.0%
1/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Gastrointestinal disorders
Perirectal fistula
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Gastrointestinal disorders
Rectal pain
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Gastrointestinal disorders
Small bowel obstruction
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
3/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
50.0%
17/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
50.0%
1/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
General disorders
Chills
|
50.0%
3/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
29.4%
10/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
General disorders
Edema face
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
General disorders
Edema limbs
|
83.3%
5/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
47.1%
16/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
General disorders
Fatigue
|
66.7%
4/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
44.1%
15/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
General disorders
Fever
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
5.9%
2/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
General disorders
Hypothermia
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
General disorders
Infusion related reaction
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
8.8%
3/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
General disorders
Malaise
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
5.9%
2/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
General disorders
Non-cardiac chest pain
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
5.9%
2/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
50.0%
1/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
General disorders
Pain
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
20.6%
7/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
General disorders
Pain at G-tube insertion site
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
General disorders
Rigors
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Hepatobiliary disorders
Hepatic abscess
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Infections and infestations
Bacteremia-Bacillus cereus
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Infections and infestations
Bacteremia-Enterococcus faecium/Coagulase negative staphylococcus
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Infections and infestations
Bacteremia-Escherichia coli/Enterobacter cloacae
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Infections and infestations
Bacteremia-Escherichia coli/pseudomonas aeruginosa
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Infections and infestations
Bacteremia-Escherichia coli/streptococcus salvarius
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Infections and infestations
Bacteremia-MRSE
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Infections and infestations
Bacteremia-Staphylococcus epidermidis
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Infections and infestations
Bacteremia-Streptococcus mitis
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Infections and infestations
Bacteremia-VRE
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Infections and infestations
Bone infection
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Infections and infestations
Catheter related infection
|
33.3%
2/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
8.8%
3/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Infections and infestations
Clostridium-difficile
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
5.9%
2/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Infections and infestations
Endocarditis infective
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Infections and infestations
Eye infection
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Infections and infestations
Fungemia-Candida parapsilosis disseminated
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Infections and infestations
HSV positive lip lesion
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
5.9%
2/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Infections and infestations
Infectious hepatic lesions secondary to colitis
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Infections and infestations
Lung infection
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
17.6%
6/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Infections and infestations
Meningitis
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Infections and infestations
Oral thrush
|
33.3%
2/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
11.8%
4/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Infections and infestations
Parotitis infectious
|
0.00%
0/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
|
Infections and infestations
Sepsis
|
16.7%
1/6 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
—
0/0 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
2.9%
1/34 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
0.00%
0/2 • Adverse events were collected from start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever comes first.
Although there were no dose-limiting toxicities for the first 6 participants treated according to Schedule A dosing, the Principal Investigator decided not to escalate to Schedule B dosing in the interest of generating additional safety data.
|
Additional Information
Geoffrey Uy, M.D.
Washington University School of Medicine
Phone: 314-747-8439
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place