NCT00064974

Efficacy and Safety Study of CC-5013 Monotherapy in Subjects With Myelodysplastic Syndromes

A Multicenter, Single-Arm, Open-Label Study of the Efficacy and Safety of CC-5013 Monotherapy in Subjects With Myelodysplastic Syndromes

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 215 (actual)
• Sponsor: Celgene Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	CC-5013	CC-5013 10 mg (two 5 mg capsules) daily on days 1-28 every 28 days (28 day cycles)

Timeline

• Start date: 2003-06-01
• Primary completion: 2007-01-01
• Completion: 2007-02-01
• First posted: 2003-07-17
• Last updated: 2013-04-04

Locations

119 sites across 15 countries: United States, Australia, Belgium, Czechia, Denmark, France, Germany, Greece, Italy, Netherlands, Russia, Spain, Sweden, Switzerland, United Kingdom