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Trial record 16 of 23 for:    "Bone Marrow Cancer" | "Protein Kinase Inhibitors"

Dasatinib as Therapy for Myeloproliferative Disorders (MPDs)

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: NCT00255346
Recruitment Status : Completed
First Posted : November 18, 2005
Results First Posted : May 6, 2019
Last Update Posted : May 6, 2019
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acute Myeloid Leukemia
Myelodysplastic Syndromes
Agnogenic Myeloid Metaplasia
Myelofibrosis
Hypereosinophilic Syndrome
Polycythemia Vera
Mastocytosis
Leukemia, Myelomonocytic, Chronic
Intervention Drug: Dasatinib (BMS-354825)
Enrollment 68
Recruitment Details Sixty-Seven participants were registered and received the study medication for this study.
Pre-assignment Details  
Arm/Group Title Acute Myeloid Leukemia (AML) MDS/CMML HES/CEL Primary Myelofibrosis (PMF) Systemic Mastocytosis (SM)
Hide Arm/Group Description

Dasatinib 70 mg orally twice daily.

Dasatinib (BMS-354825): 70 mg orally twice daily

Dasatinib 70 mg orally twice daily.

Dasatinib (BMS-354825): 70 mg orally twice daily

Dasatinib 70 mg orally twice daily.

Dasatinib (BMS-354825): 70 mg orally twice daily

Dasatinib 70 mg orally twice daily.

Dasatinib (BMS-354825): 70 mg orally twice daily

Dasatinib 70 mg orally twice daily.

Dasatinib (BMS-354825): 70 mg orally twice daily

Period Title: Overall Study
Started 10 6 8 11 33
Completed 9 6 8 11 33
Not Completed 1 0 0 0 0
Reason Not Completed
Adverse Event             1             0             0             0             0
Arm/Group Title Acute Myeloid Leukemia (AML) MDS/CMML HES/CEL Primary Myelofibrosis (PMF) Systemic Mastocytosis (SM) Total
Hide Arm/Group Description

Dasatinib 70 mg orally twice daily.

Dasatinib (BMS-354825): 70 mg orally twice daily

Dasatinib 70 mg orally twice daily.

Dasatinib (BMS-354825): 70 mg orally twice daily

Dasatinib 70 mg orally twice daily.

Dasatinib (BMS-354825): 70 mg orally twice daily

Dasatinib 70 mg orally twice daily.

Dasatinib (BMS-354825): 70 mg orally twice daily

Dasatinib 70 mg orally twice daily.

Dasatinib (BMS-354825): 70 mg orally twice daily

Total of all reporting groups
Overall Number of Baseline Participants 10 6 8 11 33 68
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 6 participants 8 participants 11 participants 33 participants 68 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
  30.0%
2
  33.3%
5
  62.5%
8
  72.7%
28
  84.8%
46
  67.6%
>=65 years
7
  70.0%
4
  66.7%
3
  37.5%
3
  27.3%
5
  15.2%
22
  32.4%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants 6 participants 8 participants 11 participants 33 participants 68 participants
70
(57 to 91)
68
(61 to 75)
62
(23 to 75)
63
(43 to 77)
57
(29 to 74)
62
(23 to 91)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 6 participants 8 participants 11 participants 33 participants 68 participants
Female
3
  30.0%
2
  33.3%
3
  37.5%
1
   9.1%
19
  57.6%
28
  41.2%
Male
7
  70.0%
4
  66.7%
5
  62.5%
10
  90.9%
14
  42.4%
40
  58.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 6 participants 8 participants 11 participants 33 participants 68 participants
American Indian or Alaska Native
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%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.0%
1
   1.5%
White
10
 100.0%
6
 100.0%
8
 100.0%
11
 100.0%
31
  93.9%
66
  97.1%
More than one race
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%
1
   3.0%
1
   1.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 6 participants 8 participants 11 participants 33 participants 68 participants
9 6 8 11 33 67
1.Primary Outcome
Title Participant Response Rate
Hide Description

Response Rate is complete response plus partial response (CR+PR) for each disease category. Response Evaluation Criteria are as follows:

Systemic Mastocytosis (SM): CR is the improvement of C-Findings, Tryptase <20, and no organomegaly. PR is the improvement of C-Findings.

Acute Myeloid Leukemia (AML)/MDS and CMML: CR is bone marrow blasts </= 5%, absolute neutrophil count (ANC) >/= 1000 and platelets >/= 100. PR is bone marrow blasts 6-25% but decreased by > 50% and absolute neutrophil count, absolute neutrophil count (ANC) >/= 1000 and platelets >/= 100.

Primary Myelofibrosis (PMF): CR is bone marrow blasts </= 5%, absolute neutrophil count (ANC) >/= 1000 and platelets >/= 100. CR is PR plus one or more of the following: ANC >/= 1000, decreased platelets by 50%, hemoglobin increase of 2g/dl or reduction splenomegaly and/or hepatomegaly by 50%.

HES/CEL: CR is disappearance of eosinophilia </= 10%, PR is reduction of eosinophilia by >/= 50%

Time Frame Baseline to completion of 4 week cycle or until disease progression
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acute Myeloid Leukemia (AML) MDS/CMML HES/CEL Primary Myelofibrosis (PMF) Systemic Mastocytosis (SM)
Hide Arm/Group Description:

Dasatinib 70 mg orally twice daily.

Dasatinib (BMS-354825): 70 mg orally twice daily

Dasatinib 70 mg orally twice daily.

Dasatinib (BMS-354825): 70 mg orally twice daily

Dasatinib 70 mg orally twice daily.

Dasatinib (BMS-354825): 70 mg orally twice daily

Dasatinib 70 mg orally twice daily.

Dasatinib (BMS-354825): 70 mg orally twice daily

Dasatinib 70 mg orally twice daily.

Dasatinib (BMS-354825): 70 mg orally twice daily

Overall Number of Participants Analyzed 9 6 8 11 33
Measure Type: Count of Participants
Unit of Measure: Participants
1
  11.1%
0
   0.0%
1
  12.5%
0
   0.0%
2
   6.1%
2.Secondary Outcome
Title Duration of Response (Survival)
Hide Description Response date to loss of response or last follow up.
Time Frame Baseline, once a week for a month, thereafter monthly, up to 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed for duration of response reflects the number of participants with a response for each arm.
Arm/Group Title Acute Myeloid Leukemia (AML) MDS/CMML HES/CEL Primary Myelofibrosis (PMF) Systemic Mastocytosis (SM)
Hide Arm/Group Description:

Dasatinib 70 mg orally twice daily.

Dasatinib (BMS-354825): 70 mg orally twice daily

Dasatinib 70 mg orally twice daily.

Dasatinib (BMS-354825): 70 mg orally twice daily

Dasatinib 70 mg orally twice daily.

Dasatinib (BMS-354825): 70 mg orally twice daily

Dasatinib 70 mg orally twice daily.

Dasatinib (BMS-354825): 70 mg orally twice daily

Dasatinib 70 mg orally twice daily.

Dasatinib (BMS-354825): 70 mg orally twice daily

Overall Number of Participants Analyzed 1 0 1 0 2
Mean (Full Range)
Unit of Measure: Months
NA [1]  NA [1] 
13
(8 to 18)
[1]
The duration of response cannot be reported for a single participant for privacy reasons
Time Frame Through study completion, up to 10 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dasatinib All Patient Groups
Hide Arm/Group Description

Dasatinib 70 mg orally twice daily.

Dasatinib (BMS-354825): 70 mg orally twice daily

All-Cause Mortality
Dasatinib All Patient Groups
Affected / at Risk (%)
Total   2/68 (2.94%)    
Hide Serious Adverse Events
Dasatinib All Patient Groups
Affected / at Risk (%) # Events
Total   2/68 (2.94%)    
Blood and lymphatic system disorders   
Hemorrhage CNS  1  1/68 (1.47%)  1
Cardiac disorders   
Pericardial Effusion  1  1/68 (1.47%)  1
Infections and infestations   
Skin Infection  1  1/68 (1.47%)  1
Respiratory, thoracic and mediastinal disorders   
Pleural Effusion  1  1/68 (1.47%)  1
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dasatinib All Patient Groups
Affected / at Risk (%) # Events
Total   67/68 (98.53%)    
Blood and lymphatic system disorders   
Edema  1  5/68 (7.35%)  5
Platelets/Hemoglobin  1  6/68 (8.82%)  6
Gastrointestinal disorders   
Diarrhea  1  5/68 (7.35%)  5
Nausea/Vomiting  1  21/68 (30.88%)  21
General disorders   
Fatigue  1  8/68 (11.76%)  8
Headache  1  12/68 (17.65%)  12
Pain  1  7/68 (10.29%)  7
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  18/68 (26.47%)  18
Pleural Effusion  1  14/68 (20.59%)  14
Skin and subcutaneous tissue disorders   
Rash  1  4/68 (5.88%)  4
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
The outcome measures were collected and reported by participant diagnosis group. The Other Adverse Events and Serious Adverse Events were collected and recorded as a group for all participants registered on the study.
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: Hagop Kantarjian, MD/Department Chair
Organization: The University of Texas MD Anderson Cancer Center
Phone: 713-792-7026
EMail: hkantarjian@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00255346    
Other Study ID Numbers: 2004-0817
NCI-2012-01353 ( Registry Identifier: NCI CTRP )
First Submitted: November 16, 2005
First Posted: November 18, 2005
Results First Submitted: April 17, 2018
Results First Posted: May 6, 2019
Last Update Posted: May 6, 2019