Trial Outcomes & Findings for An Open-Label, Phase I/II Study of Two Different Schedules of Dasatinib (Sprycel) and Decitabine (Dacogen) Used in Combination for Patients With Accelerated or Blastic Phase Chronic Myelogenous Leukemia (Protocol CA180357) (NCT NCT01498445)
NCT ID: NCT01498445
Last Updated: 2020-10-22
Results Overview
Maximum tolerated dose (MTD) defined as highest dose at which 0 of 3 or \</= 1/6 participant experience a first cycle dose limiting toxicity (DLT).
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
32 participants
Primary outcome timeframe
End of first 28-day cycle
Results posted on
2020-10-22
Participant Flow
Recruitment Period: June 2012 to April 2018
Participant milestones
| Measure |
Phase I Schedule A1
Dasatinib 100mg + Decitabine 10 mg/m2
|
Phase I Schedule A2
Dasatinib 100 mg + Decitabine 20 mg/m2
|
Phase I Schedule B1
Dasatinib 140 mg + Decitabine 10 mg/m2
|
Phase I Schedule B2
Dasatinib 140 mg+ Decitabine 20 mg/m2
|
Phase II B1
Dasatinib 140 mg + Decitabine 10 mg/m2
|
Phase II B2
Dasatinib 140 mg + Decitabine 20 mg/m2
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
8
|
8
|
4
|
5
|
|
Overall Study
COMPLETED
|
4
|
3
|
7
|
6
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
2
|
1
|
1
|
Reasons for withdrawal
| Measure |
Phase I Schedule A1
Dasatinib 100mg + Decitabine 10 mg/m2
|
Phase I Schedule A2
Dasatinib 100 mg + Decitabine 20 mg/m2
|
Phase I Schedule B1
Dasatinib 140 mg + Decitabine 10 mg/m2
|
Phase I Schedule B2
Dasatinib 140 mg+ Decitabine 20 mg/m2
|
Phase II B1
Dasatinib 140 mg + Decitabine 10 mg/m2
|
Phase II B2
Dasatinib 140 mg + Decitabine 20 mg/m2
|
|---|---|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
1
|
2
|
0
|
0
|
|
Overall Study
Screen Failure
|
0
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
An Open-Label, Phase I/II Study of Two Different Schedules of Dasatinib (Sprycel) and Decitabine (Dacogen) Used in Combination for Patients With Accelerated or Blastic Phase Chronic Myelogenous Leukemia (Protocol CA180357)
Baseline characteristics by cohort
| Measure |
Phase I - Dasatinib 100 mg + Decitabine 10 mg/m2
n=4 Participants
Less Intensive, Schedule A1 Dasatinib starting dose of 100 mg by mouth daily; Decitabine starting dose 10 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (less intensive group) Schedule A: 10 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
Phase I - Dasatinib 100 mg + Decitabine 20 mg/m2
n=3 Participants
More Intensive, Schedule A2: Dasatinib starting dose 100 mg by mouth daily; Decitabine starting dose 20 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (more intensive group) Schedule B: 20 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
Phase I - Dasatinib 140 mg + Decitabine 10 mg/m2
n=8 Participants
Less Intensive, Schedule B1 Dasatinib starting dose of 140 mg by mouth daily; Decitabine starting dose 10 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (less intensive group) Schedule A: 10 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
Phase I - Dasatinib 140 mg + Decitabine 20 mg/m2
n=8 Participants
More Intensive, Schedule B2 Dasatinib starting dose of 140 mg by mouth daily; Decitabine starting dose 20 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (more intensive group) Schedule B: 20 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
Phase II - Dasatinib 140 mg + Decitabine 10 mg/m2
n=4 Participants
Less Intensive, Schedule B1 Dasatinib starting dose of 140 mg by mouth daily; Decitabine starting dose 10 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (less intensive group) Schedule A: 10 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
Phase II - Dasatinib 140 mg + Decitabine 20 mg/m2
n=5 Participants
More Intensive, Schedule B2 Dasatinib starting dose of 140 mg by mouth daily; Decitabine starting dose 20 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (more intensive group) Schedule B: 20 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
27 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
22 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
8 participants
n=4 Participants
|
4 participants
n=21 Participants
|
5 participants
n=8 Participants
|
32 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: End of first 28-day cyclePopulation: Participants who did not complete 2 cycles of therapy were ineligible for response. Maximum Tolerate Dose (MTD) was not done for the Phase II portion of the study, therefore zero participants in the Phase II arms were analyzed for this outcome.
Maximum tolerated dose (MTD) defined as highest dose at which 0 of 3 or \</= 1/6 participant experience a first cycle dose limiting toxicity (DLT).
Outcome measures
| Measure |
Phase I - Dasatinib 100 mg + Decitabine 10 mg/m2
n=4 Participants
Less Intensive, Schedule A1 Dasatinib starting dose of 100 mg by mouth daily; Decitabine starting dose 10 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (less intensive group) Schedule A: 10 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
Phase I - Dasatinib 100 mg + Decitabine 20 mg/m2
n=3 Participants
More Intensive, Schedule A2: Dasatinib starting dose 100 mg by mouth daily; Decitabine starting dose 20 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (more intensive group) Schedule B: 20 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
Phase I - Dasatinib 140 mg + Decitabine 10 mg/m2
n=7 Participants
Less Intensive, Schedule B1 Dasatinib starting dose of 140 mg by mouth daily; Decitabine starting dose 10 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (less intensive group) Schedule A: 10 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
Phase I - Dasatinib 140 mg + Decitabine 20 mg/m2
n=6 Participants
More Intensive, Schedule B2 Dasatinib starting dose of 140 mg by mouth daily; Decitabine starting dose 20 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (more intensive group) Schedule B: 20 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
Phase II - Dasatinib 140 mg + Decitabine 10 mg/m2
Less Intensive, Schedule B1 Dasatinib starting dose of 140 mg by mouth daily; Decitabine starting dose 10 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (less intensive group) Schedule A: 10 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
Phase II - Dasatinib 140 mg + Decitabine 20 mg/m2
More Intensive, Schedule B2 Dasatinib starting dose of 140 mg by mouth daily; Decitabine starting dose 20 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (more intensive group) Schedule B: 20 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
|---|---|---|---|---|---|---|
|
Ph I Study: Maximum Tolerated Dose (MTD) Dasatinib
|
NA Milligrams
There were no dose limiting toxicities for this treatment arm
|
NA Milligrams
There were no dose limiting toxicities for this treatment arm
|
140 Milligrams
|
140 Milligrams
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 1 participant in Ph 1 Dasatinib 140 mg + Decitabine 10 mg/m\^2 arm was not evaluable for response. 2 participants in the Ph 1 Dasatinib 140 mg + Decitabine 20 mg/m\^2 arm were not evaluable for response. 1 participant in Ph II Dasatinib 140 mg + Decitabine 10mg/m\^2 and 1 participant in Ph II Dasatinib 140 mg + Decitabine 20mg/m\^2 failed screening.
Number of participants with hematologic response (HR) to therapy during first 3 months of combination dasatinib and decitabine therapy, where HR defined as any hematologic response observed during the first 3 months of treatment. Overall Hematologic Response (OHR) is defined as complete hematologic response (CHR), no evidence of leukemia (NEL) or minor hematologic response (MiHR)
Outcome measures
| Measure |
Phase I - Dasatinib 100 mg + Decitabine 10 mg/m2
n=4 Participants
Less Intensive, Schedule A1 Dasatinib starting dose of 100 mg by mouth daily; Decitabine starting dose 10 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (less intensive group) Schedule A: 10 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
Phase I - Dasatinib 100 mg + Decitabine 20 mg/m2
n=3 Participants
More Intensive, Schedule A2: Dasatinib starting dose 100 mg by mouth daily; Decitabine starting dose 20 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (more intensive group) Schedule B: 20 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
Phase I - Dasatinib 140 mg + Decitabine 10 mg/m2
n=7 Participants
Less Intensive, Schedule B1 Dasatinib starting dose of 140 mg by mouth daily; Decitabine starting dose 10 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (less intensive group) Schedule A: 10 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
Phase I - Dasatinib 140 mg + Decitabine 20 mg/m2
n=6 Participants
More Intensive, Schedule B2 Dasatinib starting dose of 140 mg by mouth daily; Decitabine starting dose 20 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (more intensive group) Schedule B: 20 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
Phase II - Dasatinib 140 mg + Decitabine 10 mg/m2
n=3 Participants
Less Intensive, Schedule B1 Dasatinib starting dose of 140 mg by mouth daily; Decitabine starting dose 10 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (less intensive group) Schedule A: 10 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
Phase II - Dasatinib 140 mg + Decitabine 20 mg/m2
n=4 Participants
More Intensive, Schedule B2 Dasatinib starting dose of 140 mg by mouth daily; Decitabine starting dose 20 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (more intensive group) Schedule B: 20 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Hematologic Responses During First 3 Months of Treatment
|
3 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to seven yearsPopulation: 1 participant in Ph 1 Dasatinib 140 mg + Decitabine 10 mg/m\^2 arm was not evaluable for response. Two participants in the Ph 1 Dasatinib 140 mg + Decitabine 20 mg/m\^2 arm were not evaluable for response.
Overall Survival will be measured from the date treatment is started to the date of death or last follow-up.
Outcome measures
| Measure |
Phase I - Dasatinib 100 mg + Decitabine 10 mg/m2
n=4 Participants
Less Intensive, Schedule A1 Dasatinib starting dose of 100 mg by mouth daily; Decitabine starting dose 10 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (less intensive group) Schedule A: 10 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
Phase I - Dasatinib 100 mg + Decitabine 20 mg/m2
n=3 Participants
More Intensive, Schedule A2: Dasatinib starting dose 100 mg by mouth daily; Decitabine starting dose 20 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (more intensive group) Schedule B: 20 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
Phase I - Dasatinib 140 mg + Decitabine 10 mg/m2
n=7 Participants
Less Intensive, Schedule B1 Dasatinib starting dose of 140 mg by mouth daily; Decitabine starting dose 10 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (less intensive group) Schedule A: 10 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
Phase I - Dasatinib 140 mg + Decitabine 20 mg/m2
n=6 Participants
More Intensive, Schedule B2 Dasatinib starting dose of 140 mg by mouth daily; Decitabine starting dose 20 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (more intensive group) Schedule B: 20 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
Phase II - Dasatinib 140 mg + Decitabine 10 mg/m2
n=3 Participants
Less Intensive, Schedule B1 Dasatinib starting dose of 140 mg by mouth daily; Decitabine starting dose 10 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (less intensive group) Schedule A: 10 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
Phase II - Dasatinib 140 mg + Decitabine 20 mg/m2
n=4 Participants
More Intensive, Schedule B2 Dasatinib starting dose of 140 mg by mouth daily; Decitabine starting dose 20 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (more intensive group) Schedule B: 20 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
|---|---|---|---|---|---|---|
|
Overall Survival
|
12.0 Months
Interval 0.6 to 36.8
|
7.0 Months
Interval 2.3 to 82.8
|
57.8 Months
Interval 0.9 to 79.4
|
58.2 Months
Interval 3.6 to 58.2
|
62.0 Months
Interval 6.0 to 62.0
|
37.5 Months
Interval 9.6 to 37.5
|
SECONDARY outcome
Timeframe: up to seven yearsPopulation: 1 participant in Ph 1 Dasatinib 140 mg + Decitabine 10 mg/m\^2 arm was not evaluable for response. Two participants in the Ph 1 Dasatinib 140 mg + Decitabine 20 mg/m\^2 arm were not evaluable for response.
Duration of Response will be measured from the date the given response is achieved to the date the response is first known to be lost
Outcome measures
| Measure |
Phase I - Dasatinib 100 mg + Decitabine 10 mg/m2
n=4 Participants
Less Intensive, Schedule A1 Dasatinib starting dose of 100 mg by mouth daily; Decitabine starting dose 10 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (less intensive group) Schedule A: 10 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
Phase I - Dasatinib 100 mg + Decitabine 20 mg/m2
n=3 Participants
More Intensive, Schedule A2: Dasatinib starting dose 100 mg by mouth daily; Decitabine starting dose 20 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (more intensive group) Schedule B: 20 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
Phase I - Dasatinib 140 mg + Decitabine 10 mg/m2
n=7 Participants
Less Intensive, Schedule B1 Dasatinib starting dose of 140 mg by mouth daily; Decitabine starting dose 10 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (less intensive group) Schedule A: 10 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
Phase I - Dasatinib 140 mg + Decitabine 20 mg/m2
n=6 Participants
More Intensive, Schedule B2 Dasatinib starting dose of 140 mg by mouth daily; Decitabine starting dose 20 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (more intensive group) Schedule B: 20 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
Phase II - Dasatinib 140 mg + Decitabine 10 mg/m2
n=3 Participants
Less Intensive, Schedule B1 Dasatinib starting dose of 140 mg by mouth daily; Decitabine starting dose 10 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (less intensive group) Schedule A: 10 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
Phase II - Dasatinib 140 mg + Decitabine 20 mg/m2
n=4 Participants
More Intensive, Schedule B2 Dasatinib starting dose of 140 mg by mouth daily; Decitabine starting dose 20 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (more intensive group) Schedule B: 20 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
|---|---|---|---|---|---|---|
|
Duration of Response
|
36.8 Months
Interval 1.2 to 36.8
|
82 Months
Interval 82.0 to 82.0
|
57.8 Months
Interval 0.09 to 79.4
|
58 Months
Interval 37.0 to 58.0
|
61 Months
Interval 1.5 to 61.0
|
37 Months
Interval 30.0 to 37.0
|
Adverse Events
Phase I - Dasatinib 100 mg + Decitabine 10 mg/m2
Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths
Phase I - Dasatinib 100 mg + Decitabine 20 mg/m2
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase I - Dasatinib 140 mg + Decitabine 10 mg/m2
Serious events: 7 serious events
Other events: 7 other events
Deaths: 2 deaths
Phase I - Dasatinib 140 mg + Decitabine 20 mg/m2
Serious events: 6 serious events
Other events: 8 other events
Deaths: 0 deaths
Phase II - Dasatinib 140 mg + Decitabine 10 mg/m2
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase II - Dasatinib 140 mg + Decitabine 20 mg/m2
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I - Dasatinib 100 mg + Decitabine 10 mg/m2
n=4 participants at risk
Less Intensive, Schedule A1 Dasatinib starting dose of 100 mg by mouth daily; Decitabine starting dose 10 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (less intensive group) Schedule A: 10 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
Phase I - Dasatinib 100 mg + Decitabine 20 mg/m2
n=3 participants at risk
More Intensive, Schedule A2: Dasatinib starting dose 100 mg by mouth daily; Decitabine starting dose 20 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (more intensive group) Schedule B: 20 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
Phase I - Dasatinib 140 mg + Decitabine 10 mg/m2
n=8 participants at risk
Less Intensive, Schedule B1 Dasatinib starting dose of 140 mg by mouth daily; Decitabine starting dose 10 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (less intensive group) Schedule A: 10 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
Phase I - Dasatinib 140 mg + Decitabine 20 mg/m2
n=8 participants at risk
More Intensive, Schedule B2 Dasatinib starting dose of 140 mg by mouth daily; Decitabine starting dose 20 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (more intensive group) Schedule B: 20 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
Phase II - Dasatinib 140 mg + Decitabine 10 mg/m2
n=4 participants at risk
Less Intensive, Schedule B1 Dasatinib starting dose of 140 mg by mouth daily; Decitabine starting dose 10 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (less intensive group) Schedule A: 10 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
Phase II - Dasatinib 140 mg + Decitabine 20 mg/m2
n=5 participants at risk
More Intensive, Schedule B2 Dasatinib starting dose of 140 mg by mouth daily; Decitabine starting dose 20 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (more intensive group) Schedule B: 20 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
|---|---|---|---|---|---|---|
|
General disorders
Abdominal Pain
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
12.5%
1/8 • Number of events 2 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Renal and urinary disorders
Acute Kidney Injury
|
25.0%
1/4 • Number of events 1 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome
|
25.0%
1/4 • Number of events 1 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
20.0%
1/5 • Number of events 1 • Up to seven years
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
12.5%
1/8 • Number of events 2 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Blood and lymphatic system disorders
Blood and Lymphatic System Disorders
|
0.00%
0/4 • Up to seven years
|
33.3%
1/3 • Number of events 1 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
25.0%
1/4 • Number of events 1 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
20.0%
1/5 • Number of events 1 • Up to seven years
|
|
Blood and lymphatic system disorders
Neutropenic Fever
|
25.0%
1/4 • Number of events 1 • Up to seven years
|
66.7%
2/3 • Number of events 2 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
20.0%
1/5 • Number of events 2 • Up to seven years
|
|
General disorders
Fever
|
25.0%
1/4 • Number of events 1 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
37.5%
3/8 • Number of events 3 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
25.0%
1/4 • Number of events 1 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Gastrointestinal disorders
Gastric Hemorrhage
|
0.00%
0/4 • Up to seven years
|
33.3%
1/3 • Number of events 1 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
General disorders
General Administration Site
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Cardiac disorders
Heart Failure
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
20.0%
1/5 • Number of events 1 • Up to seven years
|
|
Infections and infestations
Infection
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
25.0%
1/4 • Number of events 1 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Infections and infestations
Lung Infection
|
50.0%
2/4 • Number of events 2 • Up to seven years
|
33.3%
1/3 • Number of events 1 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
12.5%
1/8 • Number of events 2 • Up to seven years
|
50.0%
2/4 • Number of events 6 • Up to seven years
|
40.0%
2/5 • Number of events 2 • Up to seven years
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Skin and subcutaneous tissue disorders
Periorbital Edema
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
20.0%
1/5 • Number of events 1 • Up to seven years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
20.0%
1/5 • Number of events 1 • Up to seven years
|
|
Gastrointestinal disorders
Rectal Pain
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Renal and urinary disorders
Renal and Urinary Disorders
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
25.0%
2/8 • Number of events 2 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Thoracic and Mediastinal Disorders Other
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • Up to seven years
|
33.3%
1/3 • Number of events 1 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
25.0%
1/4 • Number of events 1 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Vascular disorders
Thromboembolic Event
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
25.0%
1/4 • Number of events 1 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Metabolism and nutrition disorders
Tumor Lysis Syndrome
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
Other adverse events
| Measure |
Phase I - Dasatinib 100 mg + Decitabine 10 mg/m2
n=4 participants at risk
Less Intensive, Schedule A1 Dasatinib starting dose of 100 mg by mouth daily; Decitabine starting dose 10 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (less intensive group) Schedule A: 10 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
Phase I - Dasatinib 100 mg + Decitabine 20 mg/m2
n=3 participants at risk
More Intensive, Schedule A2: Dasatinib starting dose 100 mg by mouth daily; Decitabine starting dose 20 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (more intensive group) Schedule B: 20 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
Phase I - Dasatinib 140 mg + Decitabine 10 mg/m2
n=8 participants at risk
Less Intensive, Schedule B1 Dasatinib starting dose of 140 mg by mouth daily; Decitabine starting dose 10 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (less intensive group) Schedule A: 10 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
Phase I - Dasatinib 140 mg + Decitabine 20 mg/m2
n=8 participants at risk
More Intensive, Schedule B2 Dasatinib starting dose of 140 mg by mouth daily; Decitabine starting dose 20 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (more intensive group) Schedule B: 20 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
Phase II - Dasatinib 140 mg + Decitabine 10 mg/m2
n=4 participants at risk
Less Intensive, Schedule B1 Dasatinib starting dose of 140 mg by mouth daily; Decitabine starting dose 10 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (less intensive group) Schedule A: 10 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
Phase II - Dasatinib 140 mg + Decitabine 20 mg/m2
n=5 participants at risk
More Intensive, Schedule B2 Dasatinib starting dose of 140 mg by mouth daily; Decitabine starting dose 20 mg/m2 by vein over 1 hour daily for 10 days; 28 day cycle.
Dasatinib: Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
Decitabine: Starting Dose (more intensive group) Schedule B: 20 mg/m2 by vein daily for 10 days of a 28 day cycle.
|
|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • Up to seven years
|
33.3%
1/3 • Number of events 1 • Up to seven years
|
37.5%
3/8 • Number of events 3 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
50.0%
4/8 • Number of events 5 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
20.0%
1/5 • Number of events 1 • Up to seven years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
2/4 • Number of events 2 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
20.0%
1/5 • Number of events 1 • Up to seven years
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
1/4 • Number of events 1 • Up to seven years
|
100.0%
3/3 • Number of events 3 • Up to seven years
|
37.5%
3/8 • Number of events 3 • Up to seven years
|
25.0%
2/8 • Number of events 2 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
2/4 • Number of events 2 • Up to seven years
|
33.3%
1/3 • Number of events 1 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
General disorders
Edema
|
25.0%
1/4 • Number of events 1 • Up to seven years
|
33.3%
1/3 • Number of events 2 • Up to seven years
|
37.5%
3/8 • Number of events 3 • Up to seven years
|
25.0%
2/8 • Number of events 3 • Up to seven years
|
50.0%
2/4 • Number of events 2 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Investigations
Elevated Amylase
|
25.0%
1/4 • Number of events 1 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Investigations
Elevated Lipase
|
25.0%
1/4 • Number of events 1 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
General disorders
Fatigue
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
50.0%
4/8 • Number of events 5 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
General disorders
Fever
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
37.5%
3/8 • Number of events 3 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
20.0%
1/5 • Number of events 1 • Up to seven years
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • Up to seven years
|
33.3%
1/3 • Number of events 1 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
62.5%
5/8 • Number of events 6 • Up to seven years
|
50.0%
2/4 • Number of events 2 • Up to seven years
|
20.0%
1/5 • Number of events 1 • Up to seven years
|
|
Investigations
Hyperbilirubinemia
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
20.0%
1/5 • Number of events 3 • Up to seven years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
40.0%
2/5 • Number of events 2 • Up to seven years
|
|
Vascular disorders
Hypotension
|
25.0%
1/4 • Number of events 1 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Infections and infestations
Infection
|
75.0%
3/4 • Number of events 3 • Up to seven years
|
33.3%
1/3 • Number of events 1 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
62.5%
5/8 • Number of events 6 • Up to seven years
|
50.0%
2/4 • Number of events 3 • Up to seven years
|
60.0%
3/5 • Number of events 4 • Up to seven years
|
|
Gastrointestinal disorders
Mucositis
|
25.0%
1/4 • Number of events 1 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
25.0%
2/8 • Number of events 2 • Up to seven years
|
25.0%
1/4 • Number of events 1 • Up to seven years
|
20.0%
1/5 • Number of events 1 • Up to seven years
|
|
Gastrointestinal disorders
Nausea
|
75.0%
3/4 • Number of events 3 • Up to seven years
|
33.3%
1/3 • Number of events 1 • Up to seven years
|
50.0%
4/8 • Number of events 5 • Up to seven years
|
37.5%
3/8 • Number of events 4 • Up to seven years
|
50.0%
2/4 • Number of events 2 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Investigations
Neutropenia
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
12.5%
1/8 • Number of events 2 • Up to seven years
|
50.0%
4/8 • Number of events 5 • Up to seven years
|
25.0%
1/4 • Number of events 3 • Up to seven years
|
40.0%
2/5 • Number of events 2 • Up to seven years
|
|
Blood and lymphatic system disorders
Neutropenic Fever
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
25.0%
1/4 • Number of events 1 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
General disorders
Pain
|
75.0%
3/4 • Number of events 9 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
50.0%
4/8 • Number of events 4 • Up to seven years
|
37.5%
3/8 • Number of events 8 • Up to seven years
|
25.0%
1/4 • Number of events 3 • Up to seven years
|
40.0%
2/5 • Number of events 6 • Up to seven years
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
1/4 • Number of events 1 • Up to seven years
|
33.3%
1/3 • Number of events 1 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
50.0%
4/8 • Number of events 6 • Up to seven years
|
25.0%
1/4 • Number of events 1 • Up to seven years
|
40.0%
2/5 • Number of events 3 • Up to seven years
|
|
General disorders
Hemorrhage
|
0.00%
0/4 • Up to seven years
|
33.3%
1/3 • Number of events 1 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Investigations
Thrombocytopenia
|
25.0%
1/4 • Number of events 1 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
25.0%
2/8 • Number of events 5 • Up to seven years
|
25.0%
1/4 • Number of events 2 • Up to seven years
|
40.0%
2/5 • Number of events 3 • Up to seven years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
25.0%
2/8 • Number of events 2 • Up to seven years
|
25.0%
1/4 • Number of events 1 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Investigations
Weight Gain
|
25.0%
1/4 • Number of events 1 • Up to seven years
|
33.3%
1/3 • Number of events 1 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Vascular disorders
Hot Flashes
|
50.0%
2/4 • Number of events 2 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Nervous system disorders
Peripheral Neuropathy
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
12.5%
1/8 • Number of events 1 • Up to seven years
|
0.00%
0/4 • Up to seven years
|
0.00%
0/5 • Up to seven years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/4 • Up to seven years
|
0.00%
0/3 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
0.00%
0/8 • Up to seven years
|
25.0%
1/4 • Number of events 1 • Up to seven years
|
20.0%
1/5 • Number of events 1 • Up to seven years
|
Additional Information
Jorge Cortes MD/Professor
The University of Texas MD Anderson Cancer Center
Phone: 713-792-7734
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place