Study to Compare the Efficacy and Safety of CC-5013 vs. Placebo in Subjects With Metastatic Malignant Melanoma.
NCT ID: NCT00057616
Last Updated: 2019-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
274 participants
INTERVENTIONAL
2002-10-01
2005-07-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Interventions
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CC-5013
Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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ICON Clinical Research
INDUSTRY
Celgene
INDUSTRY
Responsible Party
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Locations
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The Canberra Hospital
Garran, Australian Capital Territory, Australia
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Sydney Cancer Centre
Camperdown, New South Wales, Australia
Royal Newcastle Hospital
Newcastle, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Roayl Brisbane Hospital
Herston, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
Cabrini Hospital
Malvern, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Mount HospitalOncology
Perth, Western Australia, Australia
North-Estonian Regional Hospital
Tallinn, , Estonia
Tartu University Clinics Onkology & Haematology Clinic
Tartu, , Estonia
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 im Breisgau, , Germany
Universitatsklinik Eppendorf
Hamburg, , Germany
Kinkum der Christian-Albrecht-Universitat KielDepartment of Dermatologie
Kiel, , Germany
Klinik fur DermatologieVenerologie und Allergologie
Mannheim, , Germany
Latvian Onkology Centre
Riga, , Latvia
Klaipeda Hospital
Klaipėda, , Lithuania
Vilnius University Onkology Institute
Vilnius, , Lithuania
Daniel DenHoed Kliniek
Rotterdam, , Netherlands
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, , South Africa
Dnipropetrovsk State Medical Academy
Dnipropetrovsk, , Ukraine
Kharkov Postgraduate Medical Academy, Kharkov Regional Clinical Oncology Center
Kharkiv, , Ukraine
Scientific Research Institute of OncologySoft Tissue Department
Kiev, , Ukraine
Kiev City Oncology Hospital
Kiev, , Ukraine
Lviv State Medical University Regional Oncology Centre
Lviv, , Ukraine
Odessa Regional Oncology DispensaryChemotherapy Dept
Odesa, , Ukraine
Uzhgorod Regional Oncology Diepensary
Uzhhorod, , Ukraine
Cancer Centre
Egbaston, Birmingham, United Kingdom
Christies Hospital
Withington, Manchester, 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
St. George's Hospital
London, , United Kingdom
Royal Marsden Hospital Department of Oncology
London, , United Kingdom
Royal Marsden Hospital
London, , United Kingdom
Newcastle GeneralOncology
Newcastle, , United Kingdom
Countries
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References
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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.
Other Identifiers
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CC-5013-MEL-002
Identifier Type: -
Identifier Source: org_study_id
NCT00051064
Identifier Type: -
Identifier Source: nct_alias
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