Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01498445
Recruitment Status : Terminated (The study was terminated early during the phase II portion of the study due to slow enrollment.)
First Posted : December 23, 2011
Results First Posted : October 22, 2020
Last Update Posted : October 22, 2020
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Leukemia
Interventions Drug: Dasatinib
Drug: Decitabine
Enrollment 32
Recruitment Details Recruitment Period: June 2012 to April 2018
Pre-assignment Details  
Arm/Group Title Phase I Schedule A1 Phase I Schedule A2 Phase I Schedule B1 Phase I Schedule B2 Phase II B1 Phase II B2
Hide Arm/Group Description Dasatinib 100mg + Decitabine 10 mg/m2 Dasatinib 100 mg + Decitabine 20 mg/m2 Dasatinib 140 mg + Decitabine 10 mg/m2 Dasatinib 140 mg+ Decitabine 20 mg/m2 Dasatinib 140 mg + Decitabine 10 mg/m2 Dasatinib 140 mg + Decitabine 20 mg/m2
Period Title: Overall Study
Started 4 3 8 8 4 5
Completed 4 3 7 6 3 4
Not Completed 0 0 1 2 1 1
Reason Not Completed
Lack of Efficacy             0             0             1             2             0             0
Screen Failure             0             0             0             0             1             1
Arm/Group Title Phase I - Dasatinib 100 mg + Decitabine 10 mg/m2 Phase I - Dasatinib 100 mg + Decitabine 20 mg/m2 Phase I - Dasatinib 140 mg + Decitabine 10 mg/m2 Phase I - Dasatinib 140 mg + Decitabine 20 mg/m2 Phase II - Dasatinib 140 mg + Decitabine 10 mg/m2 Phase II - Dasatinib 140 mg + Decitabine 20 mg/m2 Total
Hide Arm/Group Description

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.

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.

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.

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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 4 3 8 8 4 5 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 8 participants 8 participants 4 participants 5 participants 32 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
 100.0%
3
 100.0%
7
  87.5%
7
  87.5%
4
 100.0%
2
  40.0%
27
  84.4%
>=65 years
0
   0.0%
0
   0.0%
1
  12.5%
1
  12.5%
0
   0.0%
3
  60.0%
5
  15.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 8 participants 8 participants 4 participants 5 participants 32 participants
Female
1
  25.0%
3
 100.0%
3
  37.5%
2
  25.0%
2
  50.0%
1
  20.0%
12
  37.5%
Male
3
  75.0%
0
   0.0%
5
  62.5%
6
  75.0%
2
  50.0%
4
  80.0%
20
  62.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 8 participants 8 participants 4 participants 5 participants 32 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
0
   0.0%
0
   0.0%
1
   3.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  25.0%
0
   0.0%
2
  25.0%
3
  37.5%
1
  25.0%
0
   0.0%
7
  21.9%
White
3
  75.0%
3
 100.0%
6
  75.0%
4
  50.0%
1
  25.0%
5
 100.0%
22
  68.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  50.0%
0
   0.0%
2
   6.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 3 participants 8 participants 8 participants 4 participants 5 participants 32 participants
4 3 8 8 4 5 32
1.Primary Outcome
Title Ph I Study: Maximum Tolerated Dose (MTD) Dasatinib
Hide Description 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).
Time Frame End of first 28-day cycle
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Phase I - Dasatinib 100 mg + Decitabine 10 mg/m2 Phase I - Dasatinib 100 mg + Decitabine 20 mg/m2 Phase I - Dasatinib 140 mg + Decitabine 10 mg/m2 Phase I - Dasatinib 140 mg + Decitabine 20 mg/m2 Phase II - Dasatinib 140 mg + Decitabine 10 mg/m2 Phase II - Dasatinib 140 mg + Decitabine 20 mg/m2
Hide Arm/Group Description:

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.

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.

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.

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.

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.

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 Number of Participants Analyzed 4 3 7 6 0 0
Measure Type: Number
Unit of Measure: Milligrams
NA [1]  NA [1]  140 140
[1]
There were no dose limiting toxicities for this treatment arm
2.Secondary Outcome
Title Number of Participants With Hematologic Responses During First 3 Months of Treatment
Hide Description 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)
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Phase I - Dasatinib 100 mg + Decitabine 10 mg/m2 Phase I - Dasatinib 100 mg + Decitabine 20 mg/m2 Phase I - Dasatinib 140 mg + Decitabine 10 mg/m2 Phase I - Dasatinib 140 mg + Decitabine 20 mg/m2 Phase II - Dasatinib 140 mg + Decitabine 10 mg/m2 Phase II - Dasatinib 140 mg + Decitabine 20 mg/m2
Hide Arm/Group Description:

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.

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.

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.

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.

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.

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 Number of Participants Analyzed 4 3 7 6 3 4
Measure Type: Count of Participants
Unit of Measure: Participants
3
  75.0%
1
  33.3%
5
  71.4%
4
  66.7%
3
 100.0%
3
  75.0%
3.Secondary Outcome
Title Overall Survival
Hide Description Overall Survival will be measured from the date treatment is started to the date of death or last follow-up.
Time Frame Up to seven years
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Phase I - Dasatinib 100 mg + Decitabine 10 mg/m2 Phase I - Dasatinib 100 mg + Decitabine 20 mg/m2 Phase I - Dasatinib 140 mg + Decitabine 10 mg/m2 Phase I - Dasatinib 140 mg + Decitabine 20 mg/m2 Phase II - Dasatinib 140 mg + Decitabine 10 mg/m2 Phase II - Dasatinib 140 mg + Decitabine 20 mg/m2
Hide Arm/Group Description:

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.

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.

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.

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.

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.

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 Number of Participants Analyzed 4 3 7 6 3 4
Median (Full Range)
Unit of Measure: Months
12.0
(0.6 to 36.8)
7.0
(2.3 to 82.8)
57.8
(0.9 to 79.4)
58.2
(3.6 to 58.2)
62.0
(6.0 to 62.0)
37.5
(9.6 to 37.5)
4.Secondary Outcome
Title Duration of Response
Hide Description 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
Time Frame up to seven years
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Phase I - Dasatinib 100 mg + Decitabine 10 mg/m2 Phase I - Dasatinib 100 mg + Decitabine 20 mg/m2 Phase I - Dasatinib 140 mg + Decitabine 10 mg/m2 Phase I - Dasatinib 140 mg + Decitabine 20 mg/m2 Phase II - Dasatinib 140 mg + Decitabine 10 mg/m2 Phase II - Dasatinib 140 mg + Decitabine 20 mg/m2
Hide Arm/Group Description:

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.

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.

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.

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.

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.

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 Number of Participants Analyzed 4 3 7 6 3 4
Median (Full Range)
Unit of Measure: Months
36.8
(1.2 to 36.8)
82
(82 to 82)
57.8
(.09 to 79.4)
58
(37 to 58)
61
(1.5 to 61.0)
37
(30 to 37)
Time Frame Up to seven years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phase I - Dasatinib 100 mg + Decitabine 10 mg/m2 Phase I - Dasatinib 100 mg + Decitabine 20 mg/m2 Phase I - Dasatinib 140 mg + Decitabine 10 mg/m2 Phase I - Dasatinib 140 mg + Decitabine 20 mg/m2 Phase II - Dasatinib 140 mg + Decitabine 10 mg/m2 Phase II - Dasatinib 140 mg + Decitabine 20 mg/m2
Hide Arm/Group Description

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.

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.

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.

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.

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.

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.

All-Cause Mortality
Phase I - Dasatinib 100 mg + Decitabine 10 mg/m2 Phase I - Dasatinib 100 mg + Decitabine 20 mg/m2 Phase I - Dasatinib 140 mg + Decitabine 10 mg/m2 Phase I - Dasatinib 140 mg + Decitabine 20 mg/m2 Phase II - Dasatinib 140 mg + Decitabine 10 mg/m2 Phase II - Dasatinib 140 mg + Decitabine 20 mg/m2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/4 (25.00%)      1/3 (33.33%)      2/8 (25.00%)      0/8 (0.00%)      0/4 (0.00%)      0/5 (0.00%)    
Hide Serious Adverse Events
Phase I - Dasatinib 100 mg + Decitabine 10 mg/m2 Phase I - Dasatinib 100 mg + Decitabine 20 mg/m2 Phase I - Dasatinib 140 mg + Decitabine 10 mg/m2 Phase I - Dasatinib 140 mg + Decitabine 20 mg/m2 Phase II - Dasatinib 140 mg + Decitabine 10 mg/m2 Phase II - Dasatinib 140 mg + Decitabine 20 mg/m2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/4 (75.00%)      3/3 (100.00%)      7/8 (87.50%)      6/8 (75.00%)      3/4 (75.00%)      4/5 (80.00%)    
Blood and lymphatic system disorders             
Anemia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  2 0/8 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0
Blood and Lymphatic System Disorders  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0
Neutropenic Fever  1  1/4 (25.00%)  1 2/3 (66.67%)  2 1/8 (12.50%)  1 1/8 (12.50%)  1 0/4 (0.00%)  0 1/5 (20.00%)  2
Leukocytosis  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 1/8 (12.50%)  1 0/4 (0.00%)  0 0/5 (0.00%)  0
Cardiac disorders             
Cardiac Arrest  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1 0/4 (0.00%)  0 0/5 (0.00%)  0
Chest Pain  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1 0/4 (0.00%)  0 0/5 (0.00%)  0
Heart Failure  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0
Myocardial Infarction  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1 0/4 (0.00%)  0 0/5 (0.00%)  0
Gastrointestinal disorders             
Diarrhea  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  1
Gastric Hemorrhage  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/8 (0.00%)  0 1/8 (12.50%)  1 0/4 (0.00%)  0 0/5 (0.00%)  0
Pancreatitis  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1 0/4 (0.00%)  0 0/5 (0.00%)  0
Rectal Pain  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1 0/4 (0.00%)  0 0/5 (0.00%)  0
General disorders             
Abdominal Pain  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  2 0/4 (0.00%)  0 0/5 (0.00%)  0
Fever  1  1/4 (25.00%)  1 0/3 (0.00%)  0 3/8 (37.50%)  3 1/8 (12.50%)  1 1/4 (25.00%)  1 0/5 (0.00%)  0
General Administration Site  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0
Infections and infestations             
Infection  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 1/4 (25.00%)  1 0/5 (0.00%)  0
Lung Infection  1  2/4 (50.00%)  2 1/3 (33.33%)  1 1/8 (12.50%)  1 1/8 (12.50%)  2 2/4 (50.00%)  6 2/5 (40.00%)  2
Sepsis  1  0/4 (0.00%)  0 1/3 (33.33%)  1 1/8 (12.50%)  1 0/8 (0.00%)  0 1/4 (25.00%)  1 0/5 (0.00%)  0
Metabolism and nutrition disorders             
Tumor Lysis Syndrome  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Bone Pain  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 1/4 (25.00%)  1 0/5 (0.00%)  0
Nervous system disorders             
Headache  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1 0/4 (0.00%)  0 0/5 (0.00%)  0
Psychiatric disorders             
Confusion  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0
Renal and urinary disorders             
Acute Kidney Injury  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0
Renal and Urinary Disorders  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Adult Respiratory Distress Syndrome  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  1
Pleural Effusion  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0
Pneumothorax  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0
Respiratory Failure  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 2/8 (25.00%)  2 0/4 (0.00%)  0 0/5 (0.00%)  0
Respiratory Thoracic and Mediastinal Disorders Other  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0
Skin and subcutaneous tissue disorders             
Periorbital Edema  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  1
Rash  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  1
Vascular disorders             
Hypertension  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0
Hypotension  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  1
Thromboembolic Event  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1 1/4 (25.00%)  1 0/5 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Phase I - Dasatinib 100 mg + Decitabine 10 mg/m2 Phase I - Dasatinib 100 mg + Decitabine 20 mg/m2 Phase I - Dasatinib 140 mg + Decitabine 10 mg/m2 Phase I - Dasatinib 140 mg + Decitabine 20 mg/m2 Phase II - Dasatinib 140 mg + Decitabine 10 mg/m2 Phase II - Dasatinib 140 mg + Decitabine 20 mg/m2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/4 (100.00%)      3/3 (100.00%)      7/8 (87.50%)      8/8 (100.00%)      3/4 (75.00%)      4/5 (80.00%)    
Blood and lymphatic system disorders             
Neutropenic Fever  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 1/4 (25.00%)  1 0/5 (0.00%)  0
Cardiac disorders             
Chest Pain  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0
Pericardial Effusion  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0
Gastrointestinal disorders             
Constipation  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 4/8 (50.00%)  5 0/4 (0.00%)  0 1/5 (20.00%)  1
Diarrhea  1  1/4 (25.00%)  1 3/3 (100.00%)  3 3/8 (37.50%)  3 2/8 (25.00%)  2 0/4 (0.00%)  0 0/5 (0.00%)  0
Mucositis  1  1/4 (25.00%)  1 0/3 (0.00%)  0 1/8 (12.50%)  1 2/8 (25.00%)  2 1/4 (25.00%)  1 1/5 (20.00%)  1
Nausea  1  3/4 (75.00%)  3 1/3 (33.33%)  1 4/8 (50.00%)  5 3/8 (37.50%)  4 2/4 (50.00%)  2 0/5 (0.00%)  0
Vomiting  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 2/8 (25.00%)  2 1/4 (25.00%)  1 0/5 (0.00%)  0
General disorders             
Edema  1  1/4 (25.00%)  1 1/3 (33.33%)  2 3/8 (37.50%)  3 2/8 (25.00%)  3 2/4 (50.00%)  2 0/5 (0.00%)  0
Fatigue  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 4/8 (50.00%)  5 0/4 (0.00%)  0 0/5 (0.00%)  0
Fever  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 3/8 (37.50%)  3 0/4 (0.00%)  0 1/5 (20.00%)  1
Pain  1  3/4 (75.00%)  9 0/3 (0.00%)  0 4/8 (50.00%)  4 3/8 (37.50%)  8 1/4 (25.00%)  3 2/5 (40.00%)  6
Hemorrhage  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0
Infections and infestations             
Infection  1  3/4 (75.00%)  3 1/3 (33.33%)  1 1/8 (12.50%)  1 5/8 (62.50%)  6 2/4 (50.00%)  3 3/5 (60.00%)  4
Investigations             
Elevated Amylase  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0
Elevated Lipase  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0
Hyperbilirubinemia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  3
Neutropenia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  2 4/8 (50.00%)  5 1/4 (25.00%)  3 2/5 (40.00%)  2
Thrombocytopenia  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 2/8 (25.00%)  5 1/4 (25.00%)  2 2/5 (40.00%)  3
Weight Gain  1  1/4 (25.00%)  1 1/3 (33.33%)  1 0/8 (0.00%)  0 1/8 (12.50%)  1 0/4 (0.00%)  0 0/5 (0.00%)  0
Metabolism and nutrition disorders             
Hypercalcemia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0
Hyperkalemia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0
Hypokalemia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 2/5 (40.00%)  2
Nervous system disorders             
Headache  1  0/4 (0.00%)  0 1/3 (33.33%)  1 1/8 (12.50%)  1 5/8 (62.50%)  6 2/4 (50.00%)  2 1/5 (20.00%)  1
Peripheral Neuropathy  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 1/8 (12.50%)  1 0/4 (0.00%)  0 0/5 (0.00%)  0
Psychiatric disorders             
Anxiety  1  0/4 (0.00%)  0 1/3 (33.33%)  1 3/8 (37.50%)  3 0/8 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0
Renal and urinary disorders             
Acute Kidney Injury  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Cough  1  2/4 (50.00%)  2 0/3 (0.00%)  0 1/8 (12.50%)  1 1/8 (12.50%)  1 0/4 (0.00%)  0 1/5 (20.00%)  1
Dyspnea  1  2/4 (50.00%)  2 1/3 (33.33%)  1 0/8 (0.00%)  0 1/8 (12.50%)  1 0/4 (0.00%)  0 0/5 (0.00%)  0
Pleural Effusion  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 1/4 (25.00%)  1 1/5 (20.00%)  1
Skin and subcutaneous tissue disorders             
Rash  1  1/4 (25.00%)  1 1/3 (33.33%)  1 1/8 (12.50%)  1 4/8 (50.00%)  6 1/4 (25.00%)  1 2/5 (40.00%)  3
Vascular disorders             
Hypotension  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0
Hot Flashes  1  2/4 (50.00%)  2 0/3 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jorge Cortes MD/Professor
Organization: The University of Texas MD Anderson Cancer Center
Phone: 713-792-7734
EMail: CR_Study_Registration@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01498445    
Other Study ID Numbers: 2011-0333
CA180357 ( Other Identifier: Bristol-Myers Squibb )
NCI-2012-00014 ( Registry Identifier: NCI CTRP )
First Submitted: December 21, 2011
First Posted: December 23, 2011
Results First Submitted: August 20, 2020
Results First Posted: October 22, 2020
Last Update Posted: October 22, 2020