Trial Outcomes & Findings for Randomized Efficacy Study of TPI 287 to Treat Primary Refractory or Early Relapsed Neuroblastoma (NCT NCT01505608)
NCT ID: NCT01505608
Last Updated: 2024-08-06
Results Overview
To determine the safety and tolerability of TPI 287 in combination with Irinotecan and Temozolomide (TPI+I+TMZ) in pediatric and young adult patients with primary refractory or recurrent Neuroblastoma. Phase I patients were all enrolled to receive TPI 287. Phase 2 is where randomization began. Patients were different patients than the Phase 1 patients. Below all patients that received TPI 287 are included in the TPI 287 group. This includes Phase I patients and the Phase 2 patients randomized to TPI 287.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
14 participants
Primary outcome timeframe
6 months
Results posted on
2024-08-06
Participant Flow
Phase 1- All patients assigned to TPI 287 group. Randomization began in Phase 2- Arm A patients were allowed to cross over to Arm B during cycles 1-6 if they experienced progression. 0 (zero) Arm A patients crossed over to Arm B on this study.
Participant milestones
| Measure |
Arm A- Temozolomide and Irinotecan
1. Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.
2. Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
During Phase 2- Patients who show progression on the I+TMZ arm may crossover to the I+TMZ+TPI 287 arm at anytime during cycles 1 to 6. If there is evidence of progression after completion of the I+TMZ arm (after completion of cycle 6) then the patient will have been considered to have completed therapy and is not eligible for the crossover.
Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle
Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
|
Arm B- Temozolomide/Irinotecan + TPI 287
Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287
1. Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.
2. Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.
3. Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.
Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle
Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
|
|---|---|---|
|
Phase I
STARTED
|
0
|
8
|
|
Phase I
COMPLETED
|
0
|
2
|
|
Phase I
NOT COMPLETED
|
0
|
6
|
|
Phase II
STARTED
|
2
|
4
|
|
Phase II
COMPLETED
|
0
|
2
|
|
Phase II
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Arm A- Temozolomide and Irinotecan
1. Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.
2. Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
During Phase 2- Patients who show progression on the I+TMZ arm may crossover to the I+TMZ+TPI 287 arm at anytime during cycles 1 to 6. If there is evidence of progression after completion of the I+TMZ arm (after completion of cycle 6) then the patient will have been considered to have completed therapy and is not eligible for the crossover.
Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle
Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
|
Arm B- Temozolomide/Irinotecan + TPI 287
Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287
1. Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.
2. Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.
3. Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.
Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle
Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
|
|---|---|---|
|
Phase I
Lack of Efficacy
|
0
|
4
|
|
Phase I
Adverse Event
|
0
|
1
|
|
Phase I
Withdrawal by Subject
|
0
|
1
|
|
Phase II
Lack of Efficacy
|
2
|
1
|
|
Phase II
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Randomized Efficacy Study of TPI 287 to Treat Primary Refractory or Early Relapsed Neuroblastoma
Baseline characteristics by cohort
| Measure |
Arm A- Temozolomide and Irinotecan
n=2 Participants
1. Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.
2. Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
Patients who show progression on the I+TMZ arm may crossover to the I+TMZ+TPI 287 arm at anytime during cycles 1 to 6. If there is evidence of progression after completion of the I+TMZ arm (after completion of cycle 6) then the patient will have been considered to have completed therapy and is not eligible for the crossover.
Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle
Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
|
Arm B- Temozolomide/Irinotecan + TPI 287
n=12 Participants
Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287
1. Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.
2. Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.
3. Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.
Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle
Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: This group includes the 8 patients enrolled to phase 1 TPI 287 portion of the study plus the 4 additional patients randomized to TPI 287 in the Phase 2 portion = 12 patients total that received TPI 287 on this study.
To determine the safety and tolerability of TPI 287 in combination with Irinotecan and Temozolomide (TPI+I+TMZ) in pediatric and young adult patients with primary refractory or recurrent Neuroblastoma. Phase I patients were all enrolled to receive TPI 287. Phase 2 is where randomization began. Patients were different patients than the Phase 1 patients. Below all patients that received TPI 287 are included in the TPI 287 group. This includes Phase I patients and the Phase 2 patients randomized to TPI 287.
Outcome measures
| Measure |
TPI 287
n=12 Participants
Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287
1. Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.
2. Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.
3. Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.
Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle
Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
|
Arm A- TMZ + Irinotecan Only
n=2 Participants
Did not receive TPI 287
|
|---|---|---|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
|
7 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: 8 enrolled to Phase 1: two were non-evaluable =6 move to analysis. Another 4 randomized to Arm B with TPI 287 in Phase 2=10 evaluable in TPI 287 analysis. 2 subjects were enrolled in the Phase 2 randomized portion of the trial to Arm A- without TPI 287. This makes 2 evaluable subjects in this analysis population (did not receive TPI 287).
Phase I portion of trial- All patients enrolled to recieve TPI+I+TMZ. These patients will be added to the Phase II patients that were randomized to Arm B- Arm with TPI 287 (recieved same tx as Phase I participatns). Phase II portion of trial- TPatients enrolled to this portion (different patients than enrolled to Phase 1) were randomized to Arm A: I+TMZ OR Arm B: TPI+I+TMZ Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
TPI 287
n=2 Participants
Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287
1. Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.
2. Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.
3. Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.
Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle
Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
|
Arm A- TMZ + Irinotecan Only
n=10 Participants
Did not receive TPI 287
|
|---|---|---|
|
Overall Response Rate (ORR) of Participants Using RECIST Criteria
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: PK's not run due to early closure of study. Data not collected or analyzed threfore no data exists.
To evaluate the drug levels and pharmacokinetics (PK) of TPI 287 from blood samples at multiple time points within the first 24 hours on study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 yearsPopulation: QOL's not collected due to early closure of study. Data not collected or analyzed threfore no data exists.
Evaluate the impact on QOL of children receiving TPI+I+TMZ
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 yearsPopulation: Arm A- 2 subjects randomized to TMZ+I. Arm B- 6 evalubale patients in Phase 1 + 4 evaluable patients in Phase 2- all received TMZ+I+TPI
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
TPI 287
n=2 Participants
Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287
1. Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.
2. Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.
3. Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.
Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle
Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
|
Arm A- TMZ + Irinotecan Only
n=10 Participants
Did not receive TPI 287
|
|---|---|---|
|
Progression Free Survival (PFS) of Participants Using Days Until Progression
|
22 Days
|
125 Days
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Not evaluated due to early closure. Study data does not exist.
To determine OS and clinical benefit (CR/PR/SD) in this population
Outcome measures
Outcome data not reported
Adverse Events
TPI 287
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Phase II Arm A- Subjects That Did Not Receive TPI 287
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TPI 287
n=12 participants at risk
Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287
1. Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.
2. Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.
3. Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.
Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle
Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
|
Phase II Arm A- Subjects That Did Not Receive TPI 287
n=2 participants at risk
Cycle 1 to 6: Irinotecan and Temozolomide
1. Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.
2. Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
1/12 • Number of events 1 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution, approximately 1 year.
|
0.00%
0/2 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution, approximately 1 year.
|
|
General disorders
Progression of Disease resulting in Death
|
16.7%
2/12 • Number of events 2 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution, approximately 1 year.
|
0.00%
0/2 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution, approximately 1 year.
|
Other adverse events
| Measure |
TPI 287
n=12 participants at risk
Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287
1. Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.
2. Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.
3. Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.
Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle
Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
|
Phase II Arm A- Subjects That Did Not Receive TPI 287
n=2 participants at risk
Cycle 1 to 6: Irinotecan and Temozolomide
1. Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.
2. Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
|
|---|---|---|
|
Psychiatric disorders
Agitation
|
8.3%
1/12 • Number of events 1 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution, approximately 1 year.
|
0.00%
0/2 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution, approximately 1 year.
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
4/12 • Number of events 7 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution, approximately 1 year.
|
0.00%
0/2 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution, approximately 1 year.
|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • Number of events 1 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution, approximately 1 year.
|
0.00%
0/2 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution, approximately 1 year.
|
|
Blood and lymphatic system disorders
Neutropenia
|
50.0%
6/12 • Number of events 18 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution, approximately 1 year.
|
0.00%
0/2 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution, approximately 1 year.
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
1/12 • Number of events 1 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution, approximately 1 year.
|
0.00%
0/2 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution, approximately 1 year.
|
|
Nervous system disorders
peripheral sensory neuropathy
|
8.3%
1/12 • Number of events 1 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution, approximately 1 year.
|
0.00%
0/2 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution, approximately 1 year.
|
|
General disorders
Infusion Related Reaction
|
33.3%
4/12 • Number of events 16 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution, approximately 1 year.
|
0.00%
0/2 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution, approximately 1 year.
|
|
Blood and lymphatic system disorders
lymphocytopenia
|
16.7%
2/12 • Number of events 21 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution, approximately 1 year.
|
0.00%
0/2 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution, approximately 1 year.
|
|
General disorders
Pain
|
8.3%
1/12 • Number of events 1 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution, approximately 1 year.
|
0.00%
0/2 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution, approximately 1 year.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.3%
1/12 • Number of events 1 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution, approximately 1 year.
|
0.00%
0/2 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution, approximately 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
8.3%
1/12 • Number of events 1 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution, approximately 1 year.
|
0.00%
0/2 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution, approximately 1 year.
|
|
General disorders
Weight loss
|
8.3%
1/12 • Number of events 1 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution, approximately 1 year.
|
0.00%
0/2 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution, approximately 1 year.
|
|
Blood and lymphatic system disorders
leukopenia
|
25.0%
3/12 • Number of events 11 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution, approximately 1 year.
|
0.00%
0/2 • New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution, approximately 1 year.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60