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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: Completed Phase 2 study, sponsored by Celgene Corporation.

NCT00064974 is a Phase 2 study that has completed, run by Celgene Corporation. The registered enrollment target is 215 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% higher). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 215 participants
Start Date 2003-06
Est. Completion 2007-02
Phase Phase 2
Celgene Corporation

40 total trials

What the finished NCT00064974 record still lists

NCT00064974 is an interventional study that assigns participants to a tested intervention. The registered 215 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% higher).

The record links to 0 conditions, and to 1 intervention - of which CC-5013 is the first listed.

NCT00064974 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00064974's enrollment target sits among peer trials

215 289th of 2000 higher than 1,711 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00064974, the US trial registry maintained by the National Library of Medicine. NCT00064974 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.