A Study of Dasatinib in Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00482703
First received: June 4, 2007
Last updated: November 30, 2010
Last verified: November 2010
Results First Received: July 23, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Myeloid Leukemia, Chronic
Interventions: Drug: Dasatinib
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Dasatinib 100 mg Once-daily (QD) Starting Dose Starting dose of 100 mg QD oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity.
Dasatinib 50 mg Twice-daily (BID) Starting Dose Starting dose of 50 mg BID oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity.

Participant Flow:   Overall Study
    Dasatinib 100 mg Once-daily (QD) Starting Dose     Dasatinib 50 mg Twice-daily (BID) Starting Dose  
STARTED     11 [1]   12 [1]
COMPLETED     10     12  
NOT COMPLETED     1     0  
Poor compliance                 1                 0  
[1] number enrolled, randomized and treated



  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.
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Reporting Groups
  Description
Dasatinib 100 mg Once-daily (QD) Starting Dose Starting dose of 100 mg QD oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity.
Dasatinib 50 mg Twice-daily (BID) Starting Dose Starting dose of 50 mg BID oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity.
Total Total of all reporting groups

Baseline Measures
    Dasatinib 100 mg Once-daily (QD) Starting Dose     Dasatinib 50 mg Twice-daily (BID) Starting Dose     Total  
Number of Participants  
[units: participants]
  11     12     23  
Age  
[units: years]
Mean ± Standard Deviation
  48.5  ± 14.2     49.9  ± 16.0     49.3  ± 14.8  
Age, Customized  
[units: participants]
     
<65 years     9     10     19  
>=65 years     2     2     4  
Gender  
[units: participants]
     
Female     3     5     8  
Male     8     7     15  
Region of Enrollment  
[units: participants]
     
Japan     11     12     23  
Eastern Cooperative Oncology Group Performace Status (ECOG-PS) [1]
[units: participants]
     
Status=0     11     12     23  
Status=1     0     0     0  
Status=2     0     0     0  
Status=3     0     0     0  
Status=4     0     0     0  
Status=5     0     0     0  
Imatinib Status [2]
[units: participants]
     
Imatinib-resistant     7     7     14  
Imatinib-intolerant     4     5     9  
[1] ECOG PS scale is a 6-item scale to assess disease progression, daily functioning, and appropriate treatment and prognosis. Scale=0-5, with 0=fully active, 1=restricted in physically strenuous activity but ambulatory, 2=ambulatory and capable of all selfcare but unable to work, 3= limited selfcare ability and confined to bed/chair >50% of waking hours, 4=completely disabled and no selfcare ability and confined to bed/chair, and 5=death
[2] Resistance to Imatinib=Previously treated with imatinib at a dose of ≥ 400 mg/day AND developed progressive disease while receiving imatinib at that dose. Intolerance to Imatinib=development of a Grade ≥3 toxicity considered at least possibly related to imatinib at a dose of ≤400 mg/day which led to discontinuation of therapy.



  Outcome Measures
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1.  Primary:   Cytogenetic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at Week 24   [ Time Frame: Week 24 ]

2.  Secondary:   Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations, and Deaths During Treatment   [ Time Frame: Throughout study period to last observation. Dosing period=6 months; if beneficial, medication may continue in the extension period (ending in January 2009). Last observation=30 days past last dosing day or the discontinuation day. ]

3.  Secondary:   Complete Hematologic Response (CHR) in Imatinib-Intolerant and Imatinib-Resistant Participants at Week 24   [ Time Frame: Week 24 ]

4.  Secondary:   Time to Major Cytogenetic Response (MCyR)   [ Time Frame: time from first dose of Dasatinib (BMS-354825) until the first day criteria for CCyR or PCyR, whichever occurs first, are first met ]

5.  Secondary:   Pharmacokinetics of Dasatinib (BMS-354825) as Characterized by Population Pharmacokinetics   [ Time Frame: Six or more peripheral blood samples were collected at any visit after Day 7, pre-dose and 5 - 8 hours after dose administration. ]

6.  Secondary:   Duration of MCyR   [ Time Frame: from the first day all criteria are met for CCyR or PCyR until the date of progressed disease (PD) or death ]

7.  Secondary:   Time to CHR   [ Time Frame: time from first dose of Dasatinib (BMS-354825) until the first day CHR criteria are met ]

8.  Secondary:   Duration of CHR   [ Time Frame: measured from the first day all criteria were first met for CHR (provided subjects achieved a cCHR), until the date PD is first reported or until death ]

9.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: time from first dose of Dasatinib (BMS-354825) until the first day criteria for CCyR or PCyR, whichever occurs first, are first met ]

10.  Secondary:   Expression of BCR-ABL Gene Mutations of RNA (mRNA)   [ Time Frame: Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.) ]

11.  Secondary:   Mutational Spectrum of BCR-ABL   [ Time Frame: Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.) ]

12.  Secondary:   Cytogenetic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at End of Study   [ Time Frame: Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.) ]

13.  Secondary:   Hematologic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at End of Study   [ Time Frame: Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.) ]

14.  Other Pre-specified:   Number of Participants With Major Cytogenetic Response at Months 0 - 24 (Duration of MCyR Life Table)   [ Time Frame: Months 0, 4, 8, 12, 16, 20, 24 ]

15.  Other Pre-specified:   Number of Participants With CHR at Months 0 - 24 (Duration of MCyR Life Table)   [ Time Frame: Months 0, 4, 8, 12, 16, 20, 24 ]

16.  Other Pre-specified:   Number of Participants With Progression-Free Survival (PFS) at Months 0 - 24 (PFS Life Table)   [ Time Frame: Months 0, 4, 8, 12, 16, 20, 24 ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


No publications provided


Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00482703     History of Changes
Other Study ID Numbers: CA180-138
Study First Received: June 4, 2007
Results First Received: July 23, 2010
Last Updated: November 30, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare