Study to Determine the Safety and Preliminary Efficacy of CC-1088 in the Treatment of Myelodysplastic Syndromes

This study has been completed.

First Received on September 9, 2002. Last Updated on June 23, 2005 History of Changes

Sponsor:	Celgene Corporation
Information provided by:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00045786

Purpose

The primary objective of the study is to assess the safety of CC-1088 to patients with myelodysplastic syndromes (MDS).

Condition	Intervention	Phase
Myelodysplastic Syndrome	Drug: CC-1088	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Myelodysplastic Syndromes

Drug Information available for: CC 1088

U.S. FDA Resources

Further study details as provided by Celgene Corporation:

Estimated Enrollment:	39
Study Start Date:	October 2001
Estimated Study Completion Date:	November 2005

Eligibility

Criteria

Eligible patients must have a diagnosis of MDS of at least 12 weeks that is not therapy related.
Patient must be able to adhere to the study visit schedule and other protocol requirements.
Patient must understand and voluntarily sign an informed consent document.
Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test.
Women must not be pregnant or lactating.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00045786

Locations

United States, Illinois
Rush-Presbyterian-St Luke's Medical Center
Chicago, Illinois, United States, 60612-3515

Sponsors and Collaborators

Celgene Corporation

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00045786 History of Changes
Other Study ID Numbers:	CC-1088-MDS-801-001
Study First Received:	September 9, 2002
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by Celgene Corporation:

myelodysplastic syndrome

Additional relevant MeSH terms:

Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases

Hematologic Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on February 09, 2012