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
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Melanoma, Neoplasm Metastasis
Both
Melanoma, Neoplasm Metastasis
Trial Information
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
Inclusion 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Authority:
United States: Food and Drug Administration
Study ID:
CC-5013-MEL-002
NCT ID:
NCT00057616
Start Date:
October 2002
Completion Date:
December 2004
Related Keywords:
- Melanoma
- Neoplasm Metastasis
- Metastatic Melanoma
- Melanoma
- Revimid
- CC5013
- Neoplasms
- Melanoma
- Neoplasm Metastasis
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