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| 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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Contacts and Locations
Hide Study Locations| Australia, Australian Capital Territory | |
| The Canberra Hospital | |
| Garran, Australian Capital Territory, Australia, 2605 | |
| Australia, New South Wales | |
| Sydney Cancer Centre | |
| Camperdown, New South Wales, Australia, 2145 | |
| Westmead Hospital | |
| Westmead, New South Wales, Australia, 2145 | |
| Royal Newcastle Hospital | |
| Newcastle, New South Wales, Australia, 2300 | |
| Royal Prince Alfred Hospital | |
| Camperdown, New South Wales, Australia, 2050 | |
| Australia, Queensland | |
| Roayl Brisbane Hospital | |
| Herston, Queensland, Australia, 4029 | |
| Princess Alexandra Hospital | |
| Woolloongabba, Queensland, Australia, 4102 | |
| Australia, South Australia | |
| Royal Adelaide Hospital | |
| Adelaide, South Australia, Australia, 5000 | |
| Australia, Tasmania | |
| Royal Hobart Hospital | |
| Hobart, Tasmania, Australia, 7001 | |
| Australia, Victoria | |
| Cabrini Hospital | |
| Malvern, Victoria, Australia, 3144 | |
| Australia, Western Australia | |
| Sir Charles Gairdner Hospital | |
| Nedlands, Western Australia, Australia, 6009 | |
| Mount HospitalOncology | |
| Perth, Western Australia, Australia, 6009 | |
| Estonia | |
| North-Estonian Regional Hospital | |
| Tallinn, Estonia, 11619 | |
| Tartu University Clinics Onkology & Haematology Clinic | |
| Tartu, Estonia, 51003 | |
| Germany | |
| Klinick fur Dermatologie | |
| Berlin, Germany, D-10117 | |
| Universitatsklinik Eppendorf | |
| Hamburg, Germany, D-20246 | |
| Kinkum der Christian-Albrecht-Universitat KielDepartment of Dermatologie | |
| Kiel, Germany, D-24105 | |
| Klinik fur DermatologieVenerologie und Allergologie | |
| Mannheim, Germany, D-68135 | |
| Klinick fur Dermatolgie | |
| Bonn, Germany, 53105 | |
| Dermatologie Klinik der Ruhr Universitat Bochum- St. Joseph's Hospital | |
| Bochum, Germany, 44791 | |
| Universitatsklinikum Freiburg | |
| Freiburg, Germany, 79104 | |
| Latvia | |
| Latvian Onkology Centre | |
| Riga, Latvia, LV-1079 | |
| Lithuania | |
| Vilnius University Onkology Institute | |
| Vilnius, Lithuania, LT-2600 | |
| Klaipeda Hospital | |
| Klaipeda, Lithuania, LT-5808 | |
| Netherlands | |
| Daniel DenHoed Kliniek | |
| Rotterdam, Netherlands | |
| South Africa | |
| Wilgers Hospital / Wilgers Oncology Centre | |
| Hatfield, Pretoria, South Africa, 0028 | |
| Little Company of Mary / Mary Potter Oncology Centre | |
| Pretoria, South Africa, 0002 | |
| Panorama Medi-Clinic / Panorama Oncology Unit | |
| Cape Town, South Africa, 7506 | |
| Sandton Oncology Centre | |
| Morningside, Johannesburg, South Africa | |
| Pretoria Academic Hospital / Department Medical Oncology | |
| Pretoria, South Africa | |
| Durban Oncology Centre | |
| Westridge, Durban, South Africa, 4001 | |
| Addington Hospital | |
| Durban, South Africa, 4001 | |
| St. Georges Hospital | |
| Port Elizabeth, South Africa, 6001 | |
| Ukraine | |
| Lviv State Medical University Regional Oncology Centre | |
| Lviv, Ukraine, 79010 | |
| Uzhgorod Regional Oncology Diepensary | |
| Uzhgorod, Ukraine, 88000 | |
| Odessa Regional Oncology DispensaryChemotherapy Dept | |
| Odessa, Ukraine, 65055 | |
| Kharkov Postgraduate Medical Academy, Kharkov Regional Clinical Oncology Center | |
| Kharkov, Ukraine, 61070 | |
| Scientific Research Institute of OncologySoft Tissue Department | |
| Kiev, Ukraine, 03022 | |
| Kiev City Oncology Hospital | |
| Kiev, Ukraine, 3115 | |
| Dnipropetrovsk State Medical Academy | |
| Dnipropetrovsk, Ukraine | |
| United Kingdom | |
| St. George's Hospital | |
| London, United Kingdom, SW17 0QT | |
| Beatson Oncology CentreWestern InfirmaryOncology | |
| Glasgow, United Kingdom, G11 6NT | |
| Newcastle GeneralOncology | |
| Newcastle, United Kingdom, NE4 6BE | |
| Cancer Research BldgDivsion of Cancer Medicine Research | |
| Leeds, United Kingdom, LS9 7TF | |
| Roayl Free Hospital | |
| London, United Kingdom, NW3 2QG | |
| Royal Marsden Hospital | |
| London, United Kingdom | |
| Royal Marsden Hospital Department of Oncology | |
| London, United Kingdom, SW3 6JJ | |
| United Kingdom, Birmingham | |
| Cancer Centre | |
| Egbaston, Birmingham, United Kingdom, B15 2TH | |
| United Kingdom, Manchester | |
| Christies Hospital | |
| Withington, Manchester, United Kingdom, M2O 4BX | |
More Information
| 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 |
|
Metastatic Melanoma Melanoma Revimid CC5013 |
|
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 |
