Phase II Trial of Decitabine in Patients With Chronic Myelogenous Leukemia Accelerated Phase Who Are Refractory to Imatinib Mesylate (Gleevec)
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ClinicalTrials.gov Identifier: NCT00041990 |
Recruitment Status
:
Completed
First Posted
: July 23, 2002
Last Update Posted
: December 17, 2007
|
Sponsor:
Astex Pharmaceuticals
Collaborator:
Eisai Inc.
Information provided by:
Astex Pharmaceuticals
Tracking Information | |||
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First Submitted Date ICMJE | July 19, 2002 | ||
First Posted Date ICMJE | July 23, 2002 | ||
Last Update Posted Date | December 17, 2007 | ||
Study Start Date ICMJE | July 2002 | ||
Primary Completion Date | Not Provided | ||
Current Primary Outcome Measures ICMJE | Not Provided | ||
Original Primary Outcome Measures ICMJE | Not Provided | ||
Change History | Complete list of historical versions of study NCT00041990 on ClinicalTrials.gov Archive Site | ||
Current Secondary Outcome Measures ICMJE | Not Provided | ||
Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Outcome Measures ICMJE | Not Provided | ||
Original Other Outcome Measures ICMJE | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Phase II Trial of Decitabine in Patients With Chronic Myelogenous Leukemia Accelerated Phase Who Are Refractory to Imatinib Mesylate (Gleevec) | ||
Official Title ICMJE | A Phase II, Multicenter Study of Decitabine (5-Aza-2'Deoxycytidine) in Chronic Myelogenous Leukemia Accelerated Phase Refractory to Imatinib Mesylate (STI 571) | ||
Brief Summary | To determine the safety and efficacy of decitabine in patients with Philadelphia chromosome-positive chronic myelogenous leukemia accelerated phase that were previously treated with imatinib mesylate (STI 571) and became resistant/refractory or were found to be intolerant to the drug. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase | Phase 2 | ||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Chronic Myelogenous Leukemia | ||
Intervention ICMJE | Drug: decitabine (5-aza-2'deoxycytidine) | ||
Study Arms | Not Provided | ||
Publications * | Not Provided | ||
* 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 | Completed | ||
Enrollment ICMJE |
40 | ||
Original Enrollment ICMJE | Same as current | ||
Study Completion Date | Not Provided | ||
Primary Completion Date | Not Provided | ||
Eligibility Criteria ICMJE | Inclusion:
Exclusion:
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Sex/Gender |
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Ages | 2 Years and older (Child, Adult, Senior) | ||
Accepts Healthy Volunteers | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Canada, United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00041990 | ||
Other Study ID Numbers ICMJE | DAC-013 DACO-013 |
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Has Data Monitoring Committee | Not Provided | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | Not Provided | ||
Study Sponsor ICMJE | Astex Pharmaceuticals | ||
Collaborators ICMJE | Eisai Inc. | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Astex Pharmaceuticals | ||
Verification Date | December 2007 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |