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Sponsored by: |
Celgene Corporation |
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Information provided by: | Celgene Corporation |
ClinicalTrials.gov Identifier: | NCT00055562 |
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.
Condition | Intervention | Phase |
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Melanoma Neoplasm Metastasis |
Drug: CC 5013 |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Study ID Numbers: | CDC-5013-MEL-001 |
Study First Received: | March 5, 2003 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00055562 |
Health Authority: | United States: Food and Drug Administration |
Metastatic Melanoma Metastatic Malignant Melanoma Revimid CC5013 |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Lenalidomide Neoplasm Metastasis |
Neuroepithelioma Nevus Neuroendocrine Tumors Melanoma |
Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Histologic Type Antineoplastic Agents |
Therapeutic Uses Neoplasms, Nerve Tissue Nevi and Melanomas Pharmacologic Actions |