Study to Compare the Efficacy and Safety of Two CC-5013 Dose Regimens in Subjects With Metastatic Malignant Melanoma

This study has been completed.
Sponsor:
Information provided by:
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00055562
First received: March 5, 2003
Last updated: June 23, 2005
Last verified: May 2004

March 5, 2003
June 23, 2005
January 2003
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00055562 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study to Compare the Efficacy and Safety of Two CC-5013 Dose Regimens in Subjects With Metastatic Malignant Melanoma
Multicenter, Randomized, Controlled, Double-Blind, Parallel-Group Study to Compare the Efficacy and Safety of Two CC-5013 Dose Regimens in Subjects With Metastatic Malignant Melanoma Whose Disease Has Progressed on Treatment With DTIC, IL-2 or IFN Based Therapy

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 will be treated in repeating 4 week cycles.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Melanoma
  • Neoplasm Metastasis
Drug: CC 5013
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
274
December 2004
Not Provided
  • 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00055562
CDC-5013-MEL-001
Not Provided
Not Provided
Celgene Corporation
Not Provided
Not Provided
Celgene Corporation
May 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP