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Sponsored by: |
Genentech |
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Information provided by: | Genentech |
ClinicalTrials.gov Identifier: | NCT00434226 |
This is a Phase II, randomized, controlled, open-label, multicenter trial designed to provide a preliminary assessment of the safety and efficacy of sunitinib when combined with carboplatin and paclitaxel chemotherapy and bevacizumab in patients with locally advanced, recurrent or metastatic NSCLC who have not received prior systemic therapy for NSCLC. All patients will have advanced, histologically or cytologically confirmed NSCLC (Stage IIIb with pleural effusions, Stage IV, or recurrent).
Condition | Intervention | Phase |
---|---|---|
Non-Small Cell Lung Cancer |
Drug: bevacizumab Drug: sunitinib Drug: carboplatin Drug: paclitaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment |
Official Title: | A Randomized, Controlled, Open-Label, Multicenter, Phase II Study of the Safety and Efficacy of Sunitinib in Combination With Bevacizumab, Carboplatin, and Paclitaxel in Previously Untreated Patients With Advanced Non-Small Cell Lung Cancer |
Enrollment: | 56 |
Study Start Date: | March 2007 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: bevacizumab
Intravenous repeating dose
Drug: sunitinib
Oral repeating dose
Drug: carboplatin
Intravenous repeating dose
Drug: paclitaxel
Intravenous repeating dose
|
2: Placebo Comparator |
Drug: bevacizumab
Intravenous repeating dose
Drug: carboplatin
Intravenous repeating dose
Drug: paclitaxel
Intravenous repeating dose
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Isaiah Dimery, M.D. | Genentech |
Responsible Party: | Genentech, Inc. ( Isaiah Dimery, M.D., Study Director ) |
Study ID Numbers: | AVF3996g |
Study First Received: | February 11, 2007 |
Last Updated: | July 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00434226 |
Health Authority: | United States: Food and Drug Administration |
SABER-L NSCLC Avastin Sutent |
Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Sunitinib Paclitaxel Lung Neoplasms |
Lung Diseases Carboplatin Bevacizumab Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Mitosis Modulators Antimitotic Agents Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Growth Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents, Phytogenic |