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

NCT00064974 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 215

Last updated 2013-04-04

No results posted yet for this 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.

Conditions

Interventions

DRUG

CC-5013

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

Sponsors & Collaborators

  • Celgene Corporation

    lead INDUSTRY

Principal Investigators

  • Robert Knight, MD · Celgene Corporation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-06-30
Primary Completion
2007-01-31
Completion
2007-02-28

Countries

  • United States
  • Australia
  • Belgium
  • Czechia
  • Denmark
  • France
  • Germany
  • Greece
  • Italy
  • Netherlands
  • Russia
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00064974 on ClinicalTrials.gov