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Sponsored by: |
Eli Lilly and Company |
---|---|
Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00530621 |
The purpose of this study is to determine if the combination of enzastaurin and pemetrexed can extend survival time without progression of disease for patients who have advanced or metastatic non-small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Non-Small Cell Lung Cancer |
Drug: enzastaurin Drug: placebo Drug: pemetrexed |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2 Double-Blind Randomized Study of Oral Enzastaurin HCl Versus Placebo Concurrently With Pemetrexed (Alimta®) as Second-Line Therapy in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer |
Enrollment: | 149 |
Study Start Date: | September 2007 |
Study Completion Date: | October 2008 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Active Comparator |
Drug: enzastaurin
1125 mg loading dose then 500 mg, oral, daily Cycle 1 (28 days), subsequent cycles 21 days, until disease progression
Drug: pemetrexed
500 mg/m2, IV, day 8 Cycle 1 (28 days), day 1 subsequent cycles (21 days), until disease progression
|
B: Placebo Comparator |
Drug: placebo
oral, daily
Drug: pemetrexed
500 mg/m2, IV, day 8 Cycle 1 (28 days), day 1 subsequent cycles (21 days), until disease progression
|
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: | 9820, H6Q-MC-JCBT |
Study First Received: | September 13, 2007 |
Last Updated: | December 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00530621 |
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 |