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NCT00064974 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety Study of CC-5013 Monotherapy in Subjects With Myelodysplastic Syndromes
A Phase 2 study, sponsored by Celgene Corporation.
- Completed
- Registry status
- Phase 2
- Development phase
- 215
- Enrollment target
NCT00064974 is a Phase 2 study that has completed, run by Celgene Corporation. The registered enrollment target is 215 participants.
The verdict
NCT00064974, a Phase 2 study, has completed, sponsored by Celgene Corporation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 215 participants
- Enrollment target
Study Summary
This study is a multi-center, single-arm, open-label study of oral CC-5013 monotherapy administered at a dose of 10 mg daily on Days 1-21 every 28 days (28-day cycles) to red blood cell (RBC) transfusion-dependent subjects with low- or intermediate-1-risk MDS who do not have a del (5q31-33) cytogenetic abnormality. Screening procedures will take place within 28 days of first day of study drug treatment. Subjects will receive study drug (CC-5013) in 28-day cycles for up to 6 cycles, or until bone marrow disease progression or progression/relapse following erythroid hematologic improvement (Appendix I) is documented. Study visits will occur every cycle (every 28 days) and laboratory monitoring to assess hematological parameters will occur every 14 days. Safety and efficacy assessments to be performed during the study are outlined in the Schedule of Study Assessments.
Interventions
- DRUG CC-5013
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 215 participants |
| Start Date | 2003-06 |
| Est. Completion | 2007-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00064974
The ClinicalTrials.gov registry entry for NCT00064974 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 215 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene Corporation, which has 40 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CC-5013 is the first listed.
NCT00064974 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00064974 about?
NCT00064974 is a clinical study titled "Efficacy and Safety Study of CC-5013 Monotherapy in Subjects With Myelodysplastic Syndromes". This study is a multi-center, single-arm, open-label study of oral CC-5013 monotherapy administered at a dose of 10 mg daily on Days 1-21 every 28 days (28-day cycles) to red blood cell (RBC) transfusion-dependent subjects with low- or intermediate-1-risk MDS who do not have a del (5q31-33) cytogene...
What is the current status of trial NCT00064974?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 215 participants. The study started on 2003-06. Estimated completion is 2007-02.
What interventions are being tested in trial NCT00064974?
The interventions under investigation include: CC-5013 (DRUG).
Who is sponsoring clinical trial NCT00064974?
This trial is sponsored by Celgene Corporation, which has 40 total clinical trials registered on ClinicalTrials.gov.
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