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Sponsored by: |
Eli Lilly and Company |
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Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00102804 |
This study is a randomized Phase 3, double-blind study of maintenance pemetrexed plus best supportive care versus placebo plus best supportive care in Non Small Cell Lung Cancer (NSCLC). Patients must have received one of six induction regimens for 4 cycles and did not have progressive disease prior to randomization (enrollment) into this trial.
Condition | Intervention | Phase |
---|---|---|
Non Small Cell Lung Cancer |
Drug: pemetrexed Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3, Double-Blind, Placebo-Controlled Study of Maintenance Pemetrexed Plus Best Supportive Care Versus Best Supportive Care Immediately Following Induction Treatment for Advanced Non-Small Cell Lung Cancer |
Estimated Enrollment: | 660 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | May 2009 |
Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental |
Drug: pemetrexed
500 mg/m2, IV, q 21 days, until disease progression
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B: Placebo Comparator |
Drug: Placebo
IV, q 21 days
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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:
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Responsible Party: | Eli Lilly ( Chief Medical Officer ) |
Study ID Numbers: | 5122, H3E-MC-JMEN |
Study First Received: | February 1, 2005 |
Last Updated: | June 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00102804 |
Health Authority: | United States: Food and Drug Administration |
Folic Acid Pemetrexed Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Antimetabolites Respiratory Tract Neoplasms Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site Neoplasms by Histologic Type |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Folic Acid Antagonists Pharmacologic Actions |