Trial Outcomes & Findings for CPX-351 and Glasdegib for Newly Diagnosed Acute Myelogenous Leukemia With MDS Related Changes or Therapy-related Acute Myeloid Leukemia (NCT NCT04231851)
NCT ID: NCT04231851
Last Updated: 2026-03-06
Results Overview
This is defined as the percentage of subjects with event-free survival (EFS) at 6 months. EFS is defined as the number of months where patients are in a remission state.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
6 months
Results posted on
2026-03-06
Participant Flow
Participant milestones
| Measure |
CPX-351 and Glasdegib
In Induction, subjects receive 44mg/m2/100mg/m2 IV on days 1, 3 and 5 and Glasdegib 100mg PO daily on days 6 to 28.
If re-induction is needed: Subjects receive 44mg/m2/100mg/m2 IV on days 1 and 3 and Glasdegib 100mg PO daily on days 4 to 28.
In consolidation: Subjects receive 29mg/m2/65mg/m2 IV on days 1 and 3 and Glasdegib 100mg PO daily on days 4 to 28.
If maintenance is required, Subjects receive Glasdegib 100mg PO daily for up to one year
Glasdegib: Given PO
CPX-351: Given IV
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CPX-351 and Glasdegib for Newly Diagnosed Acute Myelogenous Leukemia With MDS Related Changes or Therapy-related Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
CPX-351 and Glasdegib
n=30 Participants
In Induction, subjects receive 44mg/m2/100mg/m2 IV on days 1, 3 and 5 and Glasdegib 100mg PO daily on days 6 to 28.
If re-induction is needed: Subjects receive 44mg/m2/100mg/m2 IV on days 1 and 3 and Glasdegib 100mg PO daily on days 4 to 28.
In consolidation: Subjects receive 29mg/m2/65mg/m2 IV on days 1 and 3 and Glasdegib 100mg PO daily on days 4 to 28.
If maintenance is required, Subjects receive Glasdegib 100mg PO daily for up to one year
Glasdegib: Given PO
CPX-351: Given IV
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=41 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=41 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=41 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=41 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThis is defined as the percentage of subjects with event-free survival (EFS) at 6 months. EFS is defined as the number of months where patients are in a remission state.
Outcome measures
| Measure |
CPX-351 and Glasdegib
n=29 Participants
In Induction, subjects receive 44mg/m2/100mg/m2 IV on days 1, 3 and 5 and Glasdegib 100mg PO daily on days 6 to 28.
If re-induction is needed: Subjects receive 44mg/m2/100mg/m2 IV on days 1 and 3 and Glasdegib 100mg PO daily on days 4 to 28.
In consolidation: Subjects receive 29mg/m2/65mg/m2 IV on days 1 and 3 and Glasdegib 100mg PO daily on days 4 to 28.
If maintenance is required, Subjects receive Glasdegib 100mg PO daily for up to one year
Glasdegib: Given PO
CPX-351: Given IV
|
|---|---|
|
Percentage of Participants With Event-Free Survival at 6 Months
|
31 percentage of participants
Interval 15.0 to 48.0
|
SECONDARY outcome
Timeframe: From the start date of treatment until 4 weeks after removal of treatment due to disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year.To evaluate the tolerability of administering CPX-351 in combination with glasdegib in patients with newly diagnosed with Acute Myeloid Leukemia (AML) with Myelodysplastic Syndrome (MDS) related changes or treatment-related AML from the start of treatment, duration of treatment and up to 4 weeks after completion of study treatment. Toxicity and adverse events are based on the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0.
Outcome measures
| Measure |
CPX-351 and Glasdegib
n=30 Participants
In Induction, subjects receive 44mg/m2/100mg/m2 IV on days 1, 3 and 5 and Glasdegib 100mg PO daily on days 6 to 28.
If re-induction is needed: Subjects receive 44mg/m2/100mg/m2 IV on days 1 and 3 and Glasdegib 100mg PO daily on days 4 to 28.
In consolidation: Subjects receive 29mg/m2/65mg/m2 IV on days 1 and 3 and Glasdegib 100mg PO daily on days 4 to 28.
If maintenance is required, Subjects receive Glasdegib 100mg PO daily for up to one year
Glasdegib: Given PO
CPX-351: Given IV
|
|---|---|
|
Percentage of Grade 3-5 Adverse Events
|
26 Participants
|
SECONDARY outcome
Timeframe: From the start date of treatment until first date of CR/CRi or an average of 1 year.To assess the overall response rate to the combination of CPX-351 and glasdegib. The overall response rate (ORR) is defined as the rate of complete remissions (CR) and complete remission with incomplete count recovery (CRi). ORR = CR + CRi
Outcome measures
| Measure |
CPX-351 and Glasdegib
n=29 Participants
In Induction, subjects receive 44mg/m2/100mg/m2 IV on days 1, 3 and 5 and Glasdegib 100mg PO daily on days 6 to 28.
If re-induction is needed: Subjects receive 44mg/m2/100mg/m2 IV on days 1 and 3 and Glasdegib 100mg PO daily on days 4 to 28.
In consolidation: Subjects receive 29mg/m2/65mg/m2 IV on days 1 and 3 and Glasdegib 100mg PO daily on days 4 to 28.
If maintenance is required, Subjects receive Glasdegib 100mg PO daily for up to one year
Glasdegib: Given PO
CPX-351: Given IV
|
|---|---|
|
Overall Response Rate
|
15 Participants
|
SECONDARY outcome
Timeframe: From the start date of treatment until first date of CR/CRi or an average of 1 year.Durability of response is measured by relapse-free survival (RFS). RFS is defined as the amount of time a patient remains in remission after having achieved a CR or CRi
Outcome measures
| Measure |
CPX-351 and Glasdegib
n=15 Participants
In Induction, subjects receive 44mg/m2/100mg/m2 IV on days 1, 3 and 5 and Glasdegib 100mg PO daily on days 6 to 28.
If re-induction is needed: Subjects receive 44mg/m2/100mg/m2 IV on days 1 and 3 and Glasdegib 100mg PO daily on days 4 to 28.
In consolidation: Subjects receive 29mg/m2/65mg/m2 IV on days 1 and 3 and Glasdegib 100mg PO daily on days 4 to 28.
If maintenance is required, Subjects receive Glasdegib 100mg PO daily for up to one year
Glasdegib: Given PO
CPX-351: Given IV
|
|---|---|
|
Durability of Response
|
186 days
Interval 56.0 to 709.0
|
SECONDARY outcome
Timeframe: Time from screening biopsy for up to 12 months after the last patient is enrolled or until death from any cause, whichever came first.To evaluate the overall survival of patients with newly diagnosed with Acute Myeloid Leukemia (AML) with Myelodysplastic Syndrome (MDS) related changes or treatment-related AML.
Outcome measures
| Measure |
CPX-351 and Glasdegib
n=29 Participants
In Induction, subjects receive 44mg/m2/100mg/m2 IV on days 1, 3 and 5 and Glasdegib 100mg PO daily on days 6 to 28.
If re-induction is needed: Subjects receive 44mg/m2/100mg/m2 IV on days 1 and 3 and Glasdegib 100mg PO daily on days 4 to 28.
In consolidation: Subjects receive 29mg/m2/65mg/m2 IV on days 1 and 3 and Glasdegib 100mg PO daily on days 4 to 28.
If maintenance is required, Subjects receive Glasdegib 100mg PO daily for up to one year
Glasdegib: Given PO
CPX-351: Given IV
|
|---|---|
|
Overall Survival of Patients Who Received the Combination of CPX-351 and Glasdegib
|
10.8 Months
Interval 4.3 to 25.7
|
SECONDARY outcome
Timeframe: From the start date of treatment until laboratory studies confirmation of normal hematopoiesis or an average of 1 yearTo evaluate the time to normal hematopoiesis, process by which blood cells are formed, as determined by laboratory studies inclusive of complete blood counts (CBCs)
Outcome measures
| Measure |
CPX-351 and Glasdegib
n=15 Participants
In Induction, subjects receive 44mg/m2/100mg/m2 IV on days 1, 3 and 5 and Glasdegib 100mg PO daily on days 6 to 28.
If re-induction is needed: Subjects receive 44mg/m2/100mg/m2 IV on days 1 and 3 and Glasdegib 100mg PO daily on days 4 to 28.
In consolidation: Subjects receive 29mg/m2/65mg/m2 IV on days 1 and 3 and Glasdegib 100mg PO daily on days 4 to 28.
If maintenance is required, Subjects receive Glasdegib 100mg PO daily for up to one year
Glasdegib: Given PO
CPX-351: Given IV
|
|---|---|
|
Time to Normal Hematopoiesis as Assessed by Laboratory Studies
|
40 Days
Interval 27.0 to 61.0
|
SECONDARY outcome
Timeframe: Up to 3 yearsThis is defined as the number of participants who continue on to receive an allogenic hematopoietic stem cell transplant after induction, re-induction, or consolidation.
Outcome measures
| Measure |
CPX-351 and Glasdegib
n=15 Participants
In Induction, subjects receive 44mg/m2/100mg/m2 IV on days 1, 3 and 5 and Glasdegib 100mg PO daily on days 6 to 28.
If re-induction is needed: Subjects receive 44mg/m2/100mg/m2 IV on days 1 and 3 and Glasdegib 100mg PO daily on days 4 to 28.
In consolidation: Subjects receive 29mg/m2/65mg/m2 IV on days 1 and 3 and Glasdegib 100mg PO daily on days 4 to 28.
If maintenance is required, Subjects receive Glasdegib 100mg PO daily for up to one year
Glasdegib: Given PO
CPX-351: Given IV
|
|---|---|
|
Number of Participants Who go on to Receive an Allogenic Hematopoietic Stem Cell Transplant
|
7 Participants
|
Adverse Events
CPX-351 and Glasdegib
Serious events: 16 serious events
Other events: 28 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
CPX-351 and Glasdegib
n=30 participants at risk
In Induction, subjects receive 44mg/m2/100mg/m2 IV on days 1, 3 and 5 and Glasdegib 100mg PO daily on days 6 to 28.
If re-induction is needed: Subjects receive 44mg/m2/100mg/m2 IV on days 1 and 3 and Glasdegib 100mg PO daily on days 4 to 28.
In consolidation: Subjects receive 29mg/m2/65mg/m2 IV on days 1 and 3 and Glasdegib 100mg PO daily on days 4 to 28.
If maintenance is required, Subjects receive Glasdegib 100mg PO daily for up to one year
Glasdegib: Given PO
CPX-351: Given IV
|
|---|---|
|
Immune system disorders
Allergic Reaction - Platelet Infusion
|
3.3%
1/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Infections and infestations
Extended-spectrum beta-lactamases
|
3.3%
1/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
General disorders
Fatigue
|
3.3%
1/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
10.0%
3/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Respiratory, thoracic and mediastinal disorders
Fungal Pneumonia
|
3.3%
1/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Renal and urinary disorders
Hematuria
|
3.3%
1/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Injury, poisoning and procedural complications
Intracranial Bleed Due to Fall
|
3.3%
1/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Blood and lymphatic system disorders
Intracranial Hemmorhage
|
6.7%
2/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Infections and infestations
Mucormycosis
|
3.3%
1/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Blood and lymphatic system disorders
Neutropenic Fever
|
3.3%
1/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Infections and infestations
Neutropenic colitis
|
3.3%
1/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Infections and infestations
Peri-rectal fistula
|
3.3%
1/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Musculoskeletal and connective tissue disorders
Rectal pain
|
3.3%
1/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
6.7%
2/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Nervous system disorders
Seizure
|
3.3%
1/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Immune system disorders
Sepsis
|
20.0%
6/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Nervous system disorders
Syncopal episodes
|
3.3%
1/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Renal and urinary disorders
Urinary retention
|
3.3%
1/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Renal and urinary disorders
Urinary tract infection
|
3.3%
1/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
Other adverse events
| Measure |
CPX-351 and Glasdegib
n=30 participants at risk
In Induction, subjects receive 44mg/m2/100mg/m2 IV on days 1, 3 and 5 and Glasdegib 100mg PO daily on days 6 to 28.
If re-induction is needed: Subjects receive 44mg/m2/100mg/m2 IV on days 1 and 3 and Glasdegib 100mg PO daily on days 4 to 28.
In consolidation: Subjects receive 29mg/m2/65mg/m2 IV on days 1 and 3 and Glasdegib 100mg PO daily on days 4 to 28.
If maintenance is required, Subjects receive Glasdegib 100mg PO daily for up to one year
Glasdegib: Given PO
CPX-351: Given IV
|
|---|---|
|
General disorders
Abdominal Pain
|
6.7%
2/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Blood and lymphatic system disorders
Alanine aminotransferase increased
|
13.3%
4/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Blood and lymphatic system disorders
Alkaline phosphatase increased
|
6.7%
2/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
General disorders
Anasarca
|
6.7%
2/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Blood and lymphatic system disorders
Anemia
|
26.7%
8/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Psychiatric disorders
Anorexia
|
10.0%
3/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Blood and lymphatic system disorders
Aspartate aminotransferase increased
|
20.0%
6/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Cardiac disorders
Atrial Fibrillation
|
6.7%
2/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
General disorders
Back pain
|
13.3%
4/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Infections and infestations
Bacteremia
|
26.7%
8/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
6.7%
2/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Skin and subcutaneous tissue disorders
Bruising
|
23.3%
7/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Infections and infestations
Cellulitis
|
6.7%
2/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
General disorders
Chills
|
23.3%
7/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Nervous system disorders
Confusion
|
10.0%
3/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Gastrointestinal disorders
Constipation
|
53.3%
16/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
5/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Blood and lymphatic system disorders
Creatinine increased
|
6.7%
2/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Gastrointestinal disorders
Diarrhea
|
53.3%
16/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Ear and labyrinth disorders
Dizziness
|
16.7%
5/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Nervous system disorders
Dysgeusia
|
16.7%
5/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
3/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
23.3%
7/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Skin and subcutaneous tissue disorders
Edema
|
46.7%
14/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Nervous system disorders
Encephalopathy
|
6.7%
2/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
23.3%
7/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
6.7%
2/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
General disorders
Fatigue
|
36.7%
11/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
73.3%
22/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Nervous system disorders
Fever
|
23.3%
7/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Blood and lymphatic system disorders
Hypervolemia
|
6.7%
2/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
10.0%
3/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Gastrointestinal disorders
Gum Bleeding
|
10.0%
3/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Gastrointestinal disorders
Dark Stools
|
10.0%
3/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
General disorders
Headache
|
33.3%
10/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Blood and lymphatic system disorders
Hematoma
|
10.0%
3/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Renal and urinary disorders
Hematuria
|
6.7%
2/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Renal and urinary disorders
Hemorrhoidal Hemorrhage
|
6.7%
2/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
6.7%
2/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Nervous system disorders
Hypernatremia
|
6.7%
2/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Blood and lymphatic system disorders
Hyperphosphatemia
|
13.3%
4/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Blood and lymphatic system disorders
Hyperuricemia
|
13.3%
4/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Blood and lymphatic system disorders
Hypokalemia
|
23.3%
7/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Blood and lymphatic system disorders
Hypomagnesemia
|
36.7%
11/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Blood and lymphatic system disorders
Hyponatremia
|
16.7%
5/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Blood and lymphatic system disorders
Hypophosphatemia
|
16.7%
5/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Blood and lymphatic system disorders
Hypotension
|
13.3%
4/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
10.0%
3/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Blood and lymphatic system disorders
Intracranial hemmorhage
|
10.0%
3/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Hemorrhage
|
6.7%
2/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Musculoskeletal and connective tissue disorders
Mild extremity pain
|
10.0%
3/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Gastrointestinal disorders
Mucositis
|
33.3%
10/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramps
|
33.3%
10/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
2/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
General disorders
Nausea
|
36.7%
11/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
6.7%
2/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Infections and infestations
Neutropenic Colitis
|
6.7%
2/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
43.3%
13/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Musculoskeletal and connective tissue disorders
Non-Cardiac Chest Pain
|
16.7%
5/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Skin and subcutaneous tissue disorders
Nonpruritic maculopapular rash
|
6.7%
2/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Respiratory, thoracic and mediastinal disorders
Oral Thrush
|
16.7%
5/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Skin and subcutaneous tissue disorders
Paresthesia
|
6.7%
2/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Infections and infestations
Perirectal abscess
|
6.7%
2/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Blood and lymphatic system disorders
Platelet Count Decreased
|
63.3%
19/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.7%
2/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
10.0%
3/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Skin and subcutaneous tissue disorders
Rash
|
56.7%
17/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Renal and urinary disorders
Rectal Pain
|
13.3%
4/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
6.7%
2/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Infections and infestations
Sepsis
|
30.0%
9/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Injury, poisoning and procedural complications
Biopsy site erythematous
|
6.7%
2/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Skin and subcutaneous tissue disorders
Right Wrist Laceration
|
6.7%
2/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
10.0%
3/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Blood and lymphatic system disorders
Thrombembolic Event
|
13.3%
4/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Blood and lymphatic system disorders
Transaminitis
|
13.3%
4/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Gastrointestinal disorders
Typhilitis
|
10.0%
3/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Renal and urinary disorders
Urinary Retention
|
20.0%
6/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Renal and urinary disorders
Urinary Tract Infection
|
10.0%
3/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
2/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
General disorders
Weight Gain
|
6.7%
2/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
|
Blood and lymphatic system disorders
White Blood Cell Count Decreased
|
33.3%
10/30 • 1 year. Serious adverse events collection will start at the time patient signs consent until 28 days after the end of treatment. Adverse events will be collected from the time the research patient begins treatment until 28 days after the end of treatment. Average
|
Additional Information
Chao Family Comprehensive Cancer Center, University of California, Irvine
Chao Family Comprehensive Cancer Center, University of California, Irvine
Phone: 1-877-UC-STUDY
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place