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Sponsors and Collaborators: |
Regeneron Pharmaceuticals Sanofi-Aventis |
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Information provided by: | Regeneron Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00794417 |
The purpose of the study is to determine whether the combination of aflibercept, pemetrexed and cisplatin is safe and effective.
Condition | Intervention | Phase |
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Advanced Carcinoma Non-Small Cell Lung Cancer |
Drug: Combination of aflibercept, pemetrexed and cisplatin |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 1/2 Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Patients With Advanced Carcinoma |
Estimated Enrollment: | 100 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Combination of aflibercept, pemetrexed and cisplatin
Aflibercept in combination with pemetrexed and cisplatin administered via intravenous infusion.
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The study will be conducted in two phases. In phase 1, patients with advanced cancer will receive different doses of aflibercept in combination with approved doses of pemetrexed and cisplatin. The objective of phase 1 is to determine the safest dose of the combined study medications. This dose will then be administered to patients with previously untreated non-small cell lung cancer in phase 2. The phase 2 portion of the study will determine if the combination is effective in treating non-small cell lung cancer.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Any of the following up to 6 months (24 weeks) prior to the initial administration of aflibercept:
United States, California | |
Stanford University Medical Center | Recruiting |
Stanford, California, United States, 94305 | |
Contact: Melanie San Pedro-Salcedo 650-724-1388 msanpedro@stanford.edu | |
Principal Investigator: Heather Wakelee, MD | |
Canada, Ontario | |
Princess Margaret Hospital | Recruiting |
Toronto, Ontario, Canada | |
Contact: Lillian Siu, MD 416-946-2911 Lillian.siu@uhn.on.ca | |
Principal Investigator: Lillian Siu, MD |
Study Director: | MD | Regeneron Pharmaceuticals |
Responsible Party: | Regeneron Pharmaceuticals ( Study Manager ) |
Study ID Numbers: | VGFT-ST-0708, TCD10767 |
Study First Received: | November 19, 2008 |
Last Updated: | November 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00794417 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
advanced cancer lung cancer NSCLC |
Non-small Cell Lung Cancer aflibercept chemotherapy |
Folic Acid Pemetrexed Thoracic Neoplasms Non-small cell lung cancer Cisplatin Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Antimetabolites Respiratory Tract Neoplasms Neoplasms by Histologic Type Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs |
Enzyme Inhibitors Folic Acid Antagonists Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |