Study of Oral Dasatinib in Subjects With Myelodysplastic Syndrome (MDS) and Excess Marrow Blasts

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00624585
First received: February 15, 2008
Last updated: November 21, 2013
Last verified: May 2012
Results First Received: May 23, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Myelodysplastic Syndromes
Intervention: Drug: Dasatinib

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients with Int-2 or High risk MDS according to International Prognostic Scoring System (IPSS) score. All World Health Organization (WHO) subtypes of Myelodysplastic Syndrome (MDS), Chronic Myelomonocytic Leukemia (CMML), or Myelodysplastic / Myeloproliferative (MDS/MPD) were allowed.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Acute Myeloid Leukemia Multilineage Dysplasia (MDS/AML) with <30% blasts (RAEB-t) who either declined or were deemed unfit for induction chemotherapy were also eligible. Exclusion criteria were WBC >50,000 off hydroxyurea, another malignancy requiring radiation or chemotherapy within the past 3 years, or concurrent therapy for MDS or AML.

Reporting Groups
  Description
Dasatinib Dose Escalation Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.

Participant Flow:   Overall Study
    Dasatinib Dose Escalation  
STARTED     18  
COMPLETED     6  
NOT COMPLETED     12  
Death                 3  
Disease Progression                 6  
Adverse Event                 3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Dasatinib Dose Escalation Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.

Baseline Measures
    Dasatinib Dose Escalation  
Number of Participants  
[units: participants]
  18  
Age  
[units: years]
Mean ( Full Range )
  73.5  
  ( 60 to 84 )  
Gender  
[units: participants]
 
Female     8  
Male     10  
Region of Enrollment  
[units: participants]
 
United States     18  



  Outcome Measures
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1.  Primary:   Number of Participants With Marrow Complete Remission (CR)   [ Time Frame: 1 Year 4 Months ]

2.  Secondary:   Number of Participants With Hematologic Improvement   [ Time Frame: 1 Year 4 Months ]

3.  Secondary:   Number of Participants With Partial Remission (PR)   [ Time Frame: 1 Year 4 Months ]

4.  Secondary:   Number of Participants With Stable Disease (SD)   [ Time Frame: 1 Year 4 Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Alan F. List, Executive Vice President & President, Moffitt Medical Group
Organization: H. Lee Moffitt Cancer Center and Research Institute
phone: 813-745-6086
e-mail: alan.list@moffitt.org


No publications provided


Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00624585     History of Changes
Other Study ID Numbers: MCC-15276, CA180-106
Study First Received: February 15, 2008
Results First Received: May 23, 2012
Last Updated: November 21, 2013
Health Authority: United States: Institutional Review Board