A Study of Dasatinib in Patients With Imatinib Resistant or Intolerant Chronic Myeloid Leukemia
This study is ongoing, but not recruiting participants.
Sponsor:
Kanto CML Study Group
Collaborator:
Epidemiological and Clinical Research Information Network
Information provided by:
Kanto CML Study Group
ClinicalTrials.gov Identifier:
NCT00866736
First received: March 18, 2009
Last updated: March 7, 2011
Last verified: December 2010
Tracking Information | |||||
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First Received Date ICMJE | March 18, 2009 | ||||
Last Updated Date | March 7, 2011 | ||||
Start Date ICMJE | March 2009 | ||||
Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
rate of Major Molecular Responses (MMR) in chronic phase chronic myeloid leukemia subjects [ Time Frame: at 12 months ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00866736 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | A Study of Dasatinib in Patients With Imatinib Resistant or Intolerant Chronic Myeloid Leukemia | ||||
Official Title ICMJE | A Phase II Study of Dasatinib in Patients With Imatinib Resistant or Intolerant Chronic Myeloid Leukemia | ||||
Brief Summary | The purpose of this study is to evaluate the efficacy and the safety of dasatinib in subject with chronic phase chronic myeloid leukemia(CML) who are either resistant to or intolerant of imatinib mesylate. |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Chronic Myeloid Leukemia | ||||
Intervention ICMJE | Drug: dasatinib
100mg QD
Other Name: BMS-354825 |
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Study Arm (s) | Experimental: dasatinib
Intervention: Drug: dasatinib |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE | 60 | ||||
Estimated Completion Date | October 2013 | ||||
Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 15 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Japan | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00866736 | ||||
Other Study ID Numbers ICMJE | KCSG-01 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Hisashi Sakamaki, Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital | ||||
Study Sponsor ICMJE | Kanto CML Study Group | ||||
Collaborators ICMJE | Epidemiological and Clinical Research Information Network | ||||
Investigators ICMJE |
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Information Provided By | Kanto CML Study Group | ||||
Verification Date | December 2010 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |