Study to Compare the Efficacy and Safety of CC-5013 Vs. Placebo in Subjects With Metastatic Malignant Melanoma.

This study has been completed.

First Received: April 4, 2003 Last Updated: June 23, 2005 History of Changes

Sponsor:	Celgene Corporation
Collaborator:	ICON Clinical Research
Information provided by:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00057616

Purpose

Subjects are randomized to one of two treatment arms. All subjects are screened for eligibility within 28 days prior to randomization. The study consists of a treatment phase and a follow-up phase. Subjects are treated in repeating 4 week cycles.

Condition	Intervention	Phase
Melanoma Neoplasm Metastasis	Drug: CC-5013	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of CC-5013 Vs. Placebo in Subjects With Metastatic Malignant Melanoma Whose Disease Has Progressed on Treatment With DTIC, IL-2, or IFN Based Therapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Lenalidomide CC 5013

U.S. FDA Resources

Further study details as provided by Celgene Corporation:

Estimated Enrollment:	274
Study Start Date:	October 2002
Estimated Study Completion Date:	December 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Understand and voluntarily sign an informed consent form
Able to adhere to the study visit schedule and other protocol requirements
Metastatic malignant melanoma now stage IV, relapsed or refractory to standard metastatic therapy
Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of starting study drug
Patients with active brain disease, or newly diagnosed brain metastases, within 4 weeks prior to the start of study treatment are excluded.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057616

Show 49 Study Locations

Sponsors and Collaborators

Celgene Corporation

ICON Clinical Research

More Information

No publications provided

Study ID Numbers:	CC-5013-MEL-002
Study First Received:	April 4, 2003
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00057616 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Celgene Corporation:

Metastatic Melanoma
Melanoma
Revimid
CC5013

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Antineoplastic Agents
Neoplasms, Nerve Tissue
Lenalidomide
Pharmacologic Actions
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors

Neoplasms
Neoplastic Processes
Pathologic Processes
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Neoplasm Metastasis
Nevi and Melanomas

ClinicalTrials.gov processed this record on November 09, 2009