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Study to Compare the Efficacy and Safety of CC-5013 vs. Placebo in Subjects with Metastatic Malignant Melanoma. Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Study to Compare the Efficacy and Safety of CC-5013 vs. Placebo in Subjects with Metastatic Malignant Melanoma. conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Study to Compare the Efficacy and Safety of CC-5013 vs. Placebo in Subjects with Metastatic Malignant Melanoma. Clinical research trials and Study to Compare the Efficacy and Safety of CC-5013 vs. Placebo in Subjects with Metastatic Malignant Melanoma. healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Study to Compare the Efficacy and Safety of CC-5013 vs. Placebo in Subjects with Metastatic Malignant Melanoma.. Study to Compare the Efficacy and Safety of CC-5013 vs. Placebo in Subjects with Metastatic Malignant Melanoma. Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Study to Compare the Efficacy and Safety of CC-5013 vs. Placebo in Subjects with Metastatic Malignant Melanoma. clinical trial. Human subjects often receive the most effective healthcare possible for their Study to Compare the Efficacy and Safety of CC-5013 vs. Placebo in Subjects with Metastatic Malignant Melanoma. condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Study to Compare the Efficacy and Safety of CC-5013 vs. Placebo in Subjects with Metastatic Malignant Melanoma. Study to Compare the Efficacy and Safety of CC-5013 vs. Placebo in Subjects with Metastatic Malignant Melanoma.
Study to Compare the Efficacy and Safety of CC-5013 vs. Placebo in Subjects with Metastatic Malignant Melanoma.
For Condition: Neoplasm Metastasis,Melanoma
Status: Completed
Sponsor(s): Celgene Corporation , ICON Clinical Research
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 274
Location and Contact Information:
The Canberra Hospital
Garran, Australian Capital Territory, 2605
Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Australia
Klinick fur Dermatolgie
Bonn, , 53105
Germany
Kinkum der Christian-Albrecht-Universitat KielDepartment of Dermatologie
Kiel, , D-24105
Germany
Kharkov Postgraduate Medical Academy, Kharkov Regional Clinical Oncology Center
Kharkov, , 61070
Ukraine
Little Company of Mary / Mary Potter Oncology Centre
Pretoria, , 0002
South Africa
Sandton Oncology Centre
Morningside, Johannesburg, ,
South Africa
Royal Hobart Hospital
Hobart, Tasmania, 7001
Australia
Lviv State Medical University Regional Oncology Centre
Lviv, , 79010
Ukraine
Dnipropetrovsk State Medical Academy
Dnipropetrovsk, ,
Ukraine
Vilnius University Onkology Institute
Vilnius, , LT-2600
Lithuania
Roayl Brisbane Hospital
HERSTON, Queensland, 4029
Australia
North-Estonian Regional Hospital
Tallinn, , 11619
Estonia
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Australia
Mount HospitalOncology
Perth, Western Australia, 6009
Australia
St. Georges Hospital
Port Elizabeth, , 6001
South Africa
Addington Hospital
Durban, , 4001
South Africa
Cancer Research BldgDivsion of Cancer Medicine Research
Leeds, , LS9 7TF
United Kingdom
Uzhgorod Regional Oncology Diepensary
Uzhgorod, , 88000
Ukraine
Cancer Centre
Egbaston, Birmingham, B15 2TH
United Kingdom
Klinik fur DermatologieVenerologie und Allergologie
Mannheim, , D-68135
Germany
Sydney Cancer Centre
Camperdown, New South Wales, 2145
Australia
Wilgers Hospital / Wilgers Oncology Centre
Hatfield, Pretoria, , 0028
South Africa
Cabrini Hospital
Malvern, Victoria, 3144
Australia
Latvian Onkology Centre
Riga, , LV-1079
Latvia
Royal Marsden Hospital
London, ,
United Kingdom
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
Australia
Klinick fur Dermatologie
Berlin, , D-10117
Germany
Westmead Hospital
Westmead, New South Wales, 2145
Australia
Scientific Research Institute of OncologySoft Tissue Department
Kiev, , 03022
Ukraine
Tartu University Clinics Onkology & Haematology Clinic
Tartu, , 51003
Estonia
Daniel DenHoed Kliniek
Rotterdam, ,
Netherlands
Newcastle GeneralOncology
Newcastle, , NE4 6BE
United Kingdom
St. George's Hospital
London, , SW17 0QT
United Kingdom
Roayl Free Hospital
London, , NW3 2QG
United Kingdom
Universitatsklinik Eppendorf
Hamburg, , D-20246
Germany
Pretoria Academic Hospital / Department Medical Oncology
Pretoria, ,
South Africa
Kiev City Oncology Hospital
Kiev, , 3115
Ukraine
Klaipeda Hospital
Klaipeda, , LT-5808
Lithuania
Panorama Medi-Clinic / Panorama Oncology Unit
Cape Town, , 7506
South Africa
Christies Hospital
Withington, Manchester, M2O 4BX
United Kingdom
Universitatsklinikum Freiburg
Freiburg, , 79104
Germany
Dermatologie Klinik der Ruhr Universitat Bochum- St. Joseph's Hospital
Bochum, , 44791
Germany
Royal Newcastle Hospital
Newcastle, New South Wales, 2300
Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Australia
Royal Marsden Hospital Department of Oncology
London, , SW3 6JJ
United Kingdom
Durban Oncology Centre
Westridge, Durban, , 4001
South Africa
Beatson Oncology CentreWestern InfirmaryOncology
Glasgow, , G11 6NT
United Kingdom
Odessa Regional Oncology DispensaryChemotherapy Dept
Odessa, , 65055
Ukraine
Additional Information:
Study ID Numbers: CC-5013-MEL-002;
Study Start Date: October 2002
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00057616
Other Neoplasm Metastasis Studies:
1. A Phase II Study of Isolated Hepatic Perfusion (IHP) in Patients with Ocular Melanoma
2. Immunization of Patients with Metastatic Melanoma Using MART-1 and GP100 Peptides Modified to Increase Binding to HLA-0201
3. Treatment of Patients with Metastatic Melanoma Using Cloned Peripheral Blood Lymphocytes Sensitized In Vitro to the gp209-2M Immunodominant Peptide
4. Study of Inhaled Doxorubicin (Adriamycin) to Treat Advanced Lung Cancer
5. Monoclonal Antibody Therapy in Treating Patients With Ovarian Epithelial Cancer, Melanoma, Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Non-Small Cell Lung Cancer
Related Studies:
Other Neoplasm Metastasis Clinical Trials
Other Clinical Trials
Other Freiburg Clinical Trials
Study to Compare the Efficacy and Safety of CC-5013 vs. Placebo in Subjects with Metastatic Malignant Melanoma.
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