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

Tracking Information
First Received Date ^ICMJE	April 4, 2003
Last Updated Date	June 23, 2005
Start Date ^ICMJE	October 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00057616 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study to Compare the Efficacy and Safety of CC-5013 Vs. Placebo in Subjects With Metastatic Malignant Melanoma.
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Melanoma Neoplasm Metastasis
Intervention ^ICMJE	Drug: CC-5013
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	274
Completion Date	December 2004
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Australia, Estonia, Germany, Latvia, Lithuania, Netherlands, South Africa, Ukraine, United Kingdom

Administrative Information
NCT ID ^ICMJE	NCT00057616
Responsible Party
Study ID Numbers ^ICMJE	CC-5013-MEL-002
Study Sponsor ^ICMJE	Celgene Corporation
Collaborators ^ICMJE	ICON Clinical Research
Investigators ^ICMJE
Information Provided By	Celgene Corporation
Verification Date	May 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP