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CLINICAL TRIALS PROFILE FOR NEXAVAR

Clinical Trials for Nexavar

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Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00064350	Sorafenib in Treating Patients With Refractory Non-Small Cell Lung Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2004-05-01	RATIONALE: Preclinical studies indicate that sorafenib is a potent inhibitor of Raf kinase in vitro and in vivo, with significant dose-dependent, anti-tumor activity in four different human tumor types including colon, pancreatic, lung, and ovarian. This activity was cytostatic in nature and was maintained if dosing was continued. That is, tumor growth is suspended while the drug is administered but returns to baseline rates when the agent is withdrawn. Therefore, the optimal schedule will be an uninterrupted one. To assess the activity of sorafenib in a timely manner and with a meaningful interpretation, a randomized discontinuation design was adopted in the present trial, conducted in a population who were potentially sensitive to sorafenib. PURPOSE: This randomized phase II trial is studying sorafenib to see how well it works compared to placebo in treating patients with refractory non-small cell lung cancer.
NCT00064350	Sorafenib in Treating Patients With Refractory Non-Small Cell Lung Cancer	Completed	Eastern Cooperative Oncology Group	Phase 2	2004-05-01	RATIONALE: Preclinical studies indicate that sorafenib is a potent inhibitor of Raf kinase in vitro and in vivo, with significant dose-dependent, anti-tumor activity in four different human tumor types including colon, pancreatic, lung, and ovarian. This activity was cytostatic in nature and was maintained if dosing was continued. That is, tumor growth is suspended while the drug is administered but returns to baseline rates when the agent is withdrawn. Therefore, the optimal schedule will be an uninterrupted one. To assess the activity of sorafenib in a timely manner and with a meaningful interpretation, a randomized discontinuation design was adopted in the present trial, conducted in a population who were potentially sensitive to sorafenib. PURPOSE: This randomized phase II trial is studying sorafenib to see how well it works compared to placebo in treating patients with refractory non-small cell lung cancer.
NCT00079612	Study of Nexavar (Sorafenib, BAY 43-9006) in Patients With Advanced Refractory Cancer	Completed	Onyx Pharmaceuticals	Phase 2	2002-09-01	The purpose of the study is to: - Find out if BAY 43-9006 prevents the growth of tumors - For patients who have stable cancer status after 3 months of treatment if it is safer and/or more effective to continue to give BAY 43-9006 or to stop giving BAY 43-9006 at that time. - Find out how long the effect of BAY 43-9006 is on tumors. To assess the safety of BAY 43-9006 (sorafenib) in the treatment of advanced refractory cancers. - Measure the amount of BAY 43-9006 and some of its targets in the blood stream in some patients.
NCT00079612	Study of Nexavar (Sorafenib, BAY 43-9006) in Patients With Advanced Refractory Cancer	Completed	Bayer	Phase 2	2002-09-01	The purpose of the study is to: - Find out if BAY 43-9006 prevents the growth of tumors - For patients who have stable cancer status after 3 months of treatment if it is safer and/or more effective to continue to give BAY 43-9006 or to stop giving BAY 43-9006 at that time. - Find out how long the effect of BAY 43-9006 is on tumors. To assess the safety of BAY 43-9006 (sorafenib) in the treatment of advanced refractory cancers. - Measure the amount of BAY 43-9006 and some of its targets in the blood stream in some patients.
NCT00093613	Sorafenib in Treating Patients With Recurrent or Progressive Malignant Glioma	Completed	National Cancer Institute (NCI)	Phase 1	2004-12-01	This phase I trial is studying the side effects and best dose of sorafenib in treating patients with recurrent or progressive malignant glioma. Sorafenib may stop the growth of tumor cells by stopping blood flow to the tumor and by blocking the enzymes necessary for their growth.
NCT00093626	Sorafenib in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Peritoneal Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2004-10-01	Sorafenib may stop the growth of tumor cells by stopping blood flow to the tumor and by blocking the enzymes necessary for their growth. This phase II trial is studying how well sorafenib works in treating patients with persistent or recurrent ovarian epithelial or peritoneal cancer.
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