Melanoma Clinical Trial
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
| Verified date | November 2019 |
| Source | Celgene |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 274 |
| Est. completion date | July 15, 2005 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
- 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. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Royal Adelaide Hospital | Adelaide | South Australia |
| Australia | Royal Prince Alfred Hospital | Camperdown | New South Wales |
| Australia | Sydney Cancer Centre | Camperdown | New South Wales |
| Australia | The Canberra Hospital | Garran | Australian Capital Territory |
| Australia | Roayl Brisbane Hospital | Herston | Queensland |
| Australia | Royal Hobart Hospital | Hobart | Tasmania |
| Australia | Cabrini Hospital | Malvern | Victoria |
| Australia | Sir Charles Gairdner Hospital | Nedlands | Western Australia |
| Australia | Royal Newcastle Hospital | Newcastle | New South Wales |
| Australia | Mount HospitalOncology | Perth | Western Australia |
| Australia | Westmead Hospital | Westmead | New South Wales |
| Australia | Princess Alexandra Hospital | Woolloongabba | Queensland |
| Estonia | North-Estonian Regional Hospital | Tallinn | |
| Estonia | Tartu University Clinics Onkology & Haematology Clinic | Tartu | |
| Germany | Klinick fur Dermatologie | Berlin | |
| Germany | Dermatologie Klinik der Ruhr Universitat Bochum- St. Joseph's Hospital | Bochum | |
| Germany | Klinick fur Dermatolgie | Bonn | |
| Germany | Universitatsklinikum Freiburg | Freiburg | |
| Germany | Universitatsklinik Eppendorf | Hamburg | |
| Germany | Kinkum der Christian-Albrecht-Universitat KielDepartment of Dermatologie | Kiel | |
| Germany | Klinik fur DermatologieVenerologie und Allergologie | Mannheim | |
| Latvia | Latvian Onkology Centre | Riga | |
| Lithuania | Klaipeda Hospital | Klaipeda | |
| Lithuania | Vilnius University Onkology Institute | Vilnius | |
| Netherlands | Daniel DenHoed Kliniek | Rotterdam | |
| South Africa | Panorama Medi-Clinic / Panorama Oncology Unit | Cape Town | |
| South Africa | Addington Hospital | Durban | |
| South Africa | Wilgers Hospital / Wilgers Oncology Centre | Hatfield, Pretoria | |
| South Africa | Sandton Oncology Centre | Morningside, Johannesburg | |
| South Africa | St. Georges Hospital | Port Elizabeth | |
| South Africa | Little Company of Mary / Mary Potter Oncology Centre | Pretoria | |
| South Africa | Pretoria Academic Hospital / Department Medical Oncology | Pretoria | |
| South Africa | Durban Oncology Centre | Westridge, Durban | |
| Ukraine | Dnipropetrovsk State Medical Academy | Dnipropetrovsk | |
| Ukraine | Kharkov Postgraduate Medical Academy, Kharkov Regional Clinical Oncology Center | Kharkov | |
| Ukraine | Kiev City Oncology Hospital | Kiev | |
| Ukraine | Scientific Research Institute of OncologySoft Tissue Department | Kiev | |
| Ukraine | Lviv State Medical University Regional Oncology Centre | Lviv | |
| Ukraine | Odessa Regional Oncology DispensaryChemotherapy Dept | Odessa | |
| Ukraine | Uzhgorod Regional Oncology Diepensary | Uzhgorod | |
| United Kingdom | Cancer Centre | Egbaston | Birmingham |
| United Kingdom | Beatson Oncology CentreWestern InfirmaryOncology | Glasgow | |
| United Kingdom | Cancer Research BldgDivsion of Cancer Medicine Research | Leeds | |
| United Kingdom | Roayl Free Hospital | London | |
| United Kingdom | Royal Marsden Hospital | London | |
| United Kingdom | Royal Marsden Hospital Department of Oncology | London | |
| United Kingdom | St. George's Hospital | London | |
| United Kingdom | Newcastle GeneralOncology | Newcastle | |
| United Kingdom | Christies Hospital | Withington | Manchester |
| Lead Sponsor | Collaborator |
|---|---|
| Celgene | ICON Clinical Research |
Australia, Estonia, Germany, Latvia, Lithuania, Netherlands, South Africa, Ukraine, United Kingdom,
Eisen T, Trefzer U, Hamilton A, Hersey P, Millward M, Knight RD, Jungnelius JU, Glaspy J. Results of a multicenter, randomized, double-blind phase 2/3 study of lenalidomide in the treatment of pretreated relapsed or refractory metastatic malignant melanoma. Cancer. 2010 Jan 1;116(1):146-54. doi: 10.1002/cncr.24686. — View Citation
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