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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00492297 |
The purpose of this study is to see whether a new type of anti-cancer drug, known as BAY 43-9006, can be given safely and with good effect in combination with DTIC. DTIC is the current standard chemotherapy drug given for melanoma that has spread through the body. Although this drug can be effective on its own and is generally well tolerated, not all patients will benefit, so there is a need to test new drugs and drug combinations for treating melanoma.
Condition | Intervention | Phase |
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Cancer Melanoma |
Drug: Nexavar (Sorafenib, BAY43-9006) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Multi-Center, Open-Label, Uncontrolled Study to Evaluate the Efficacy and Safety of BAY 43-9006 Given Daily in Combination With Repeated 21-Day Cycles of Dacarbazine (DTIC) Chemotherapy in Subjects With Advanced Metastatic Melanoma. |
Enrollment: | 82 |
Study Start Date: | April 2005 |
Study Completion Date: | June 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 1: Experimental |
Drug: Nexavar (Sorafenib, BAY43-9006)
Multi Kinase Inhibitor: Dacarbazine 1000mg/m2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib, 400mg bid
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
VILLEJUIF CEDEX, France, 94305 | |
LYON CEDEX, France, 69008 | |
BORDEAUX, France, 33000 | |
TOULOUSE, France, 31052 | |
United Kingdom, Cambridgeshire | |
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ | |
United Kingdom, Greater London | |
London, Greater London, United Kingdom, SW3 6JJ | |
London, Greater London, United Kingdom, NW3 2QG | |
London, Greater London, United Kingdom, SE1 7EH | |
United Kingdom, Greater Manchester | |
Manchester, Greater Manchester, United Kingdom, M20 4BX | |
United Kingdom, Hampshire | |
Southampton, Hampshire, United Kingdom, SO16 6YD | |
United Kingdom, Middlesex | |
Northwood, Middlesex, United Kingdom, HA6 2RN | |
United Kingdom, Surrey | |
Sutton, Surrey, United Kingdom, SM2 5PT |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer Healthcare Pharmaceuticals Inc. ( Therapeutic Area Head ) |
Study ID Numbers: | 11538, EudraCT 2004-000725-30 |
Study First Received: | June 26, 2007 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00492297 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; France: Afssaps - French Health Products Safety Agency |
Neuroectodermal Tumors Dacarbazine Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Nevus Sorafenib Neuroendocrine Tumors Melanoma |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Neoplasms, Nerve Tissue |
Enzyme Inhibitors Nevi and Melanomas Antineoplastic Agents, Alkylating Protein Kinase Inhibitors Alkylating Agents Pharmacologic Actions |