A Phase I, Open-Label, Dose-Escalation Study of CC-11006 In Subjects With Low- or Intermediate-1 Risk Myelodysplastic Syndromes

Phase 1

Terminated

• Conditions: Myelodysplastic Syndrome
• Interventions: Drug: CC-11006

• Registration Number: NCT00458159
• Lead Sponsor: Celgene

Brief Summary

A Phase I, Open-Label, Dose-Escalation Study of CC-11006 In Subjects With Low- or Intermediate-1 Risk Myelodysplastic Syndromes.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-04-05
• Study First Submitted QC: 2007-04-06
• Study First Posted: 2007-04-09
• Study Start: 2007-05-01
• Primary Completion: 2008-10-01
• Study Completion: 2008-12-01
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-11
• Last Update Posted: 2019-12-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	CC-11006	-

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose of CC-11006	2 cohorts

Secondary Outcome Measures

Name	Time	Method
Safety of CC-11006-MDS-001	Ongoing basis

Trial Locations

Locations (7)

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States

Indiana University Medical Center; 🇺🇸 Indianapolis, Indiana, United States

Center for Cancer and Blood Disorders; 🇺🇸 Bethesda, Maryland, United States

New York Presbyterian Hospital-Weill Cornell Medical College; 🇺🇸 New York, New York, United States

Wake Forest University School of Medicine Bowman Gray Campus, Comprehensive Cancer Center; 🇺🇸 Winston-Salem, North Carolina, United States

The Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States