Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome
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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: NCT00044382 |
Recruitment Status
:
Completed
First Posted
: August 29, 2002
Last Update Posted
: June 17, 2009
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Sponsor:
Celgene Corporation
Information provided by:
Celgene
Tracking Information | |||
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First Submitted Date ICMJE | August 27, 2002 | ||
First Posted Date ICMJE | August 29, 2002 | ||
Last Update Posted Date | June 17, 2009 | ||
Study Start Date ICMJE | February 2002 | ||
Actual Primary Completion Date | January 2007 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE | Not Provided | ||
Original Primary Outcome Measures ICMJE | Not Provided | ||
Change History | Complete list of historical versions of study NCT00044382 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 | Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome | ||
Official Title ICMJE | A Phase II Open Label Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome | ||
Brief Summary | To estimate the percent of patients with myelodysplastic syndromes (MDS) who experience erythroid response and the interval to response with daily treatment of 25 mg of CC-5013 . | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase | Phase 2 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Myelodysplastic Syndrome | ||
Intervention ICMJE | Drug: CC-5013 | ||
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 |
25 | ||
Original Enrollment ICMJE | Same as current | ||
Study Completion Date | Not Provided | ||
Actual Primary Completion Date | January 2007 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE |
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||
Accepts Healthy Volunteers | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00044382 | ||
Other Study ID Numbers ICMJE | CC-5013-MDS-501-001 | ||
Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | Deborah Ingenito, Celgene Corporation | ||
Study Sponsor ICMJE | Celgene Corporation | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Celgene | ||
Verification Date | June 2009 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |