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Sponsors and Collaborators: |
Eli Lilly and Company Genentech |
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Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00533429 |
The purpose of this study is to determine if Pemetrexed plus Carboplatin plus Bevacizumab plus Enzastaurin, followed by maintenance Bevacizumab plus Enzastaurin can extend survival time without disease progression in the first-line treatment of patients with advanced stage non-small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Non-Small Cell Lung Cancer |
Drug: enzastaurin Drug: pemetrexed Drug: carboplatin Drug: bevacizumab Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Protocol H6Q-MC-S034(a) Randomized, Double-Blind, Phase 2 Study of Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin Versus Pemetrexed + Carboplatin + Bevacizumab + Placebo in Chemonaive Patients With Stage IIIB or IV Non-Small Cell Lung Cancer |
Estimated Enrollment: | 90 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental |
Drug: enzastaurin
1125 mg loading dose then 500 mg, oral, daily until disease progression
Drug: pemetrexed
500 mg/m2, IV, day 8 of cycle 1 - 28 days, day 1 of subsequent cycles q 21 days x 3 cycles
Drug: carboplatin
AUC 6, IV day 8 cycle 1 - 28 days, day 1 of subsequent cycles q 21 days x 3 cycles
Drug: bevacizumab
15 mg/kg, IV, Day 8 of cycle 1 - 28 days, day 1 of subsequent cycles q 21 days x 3 cycles
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B: Placebo Comparator |
Drug: pemetrexed
500 mg/m2, IV, day 8 of cycle 1 - 28 days, day 1 of subsequent cycles q 21 days x 3 cycles
Drug: carboplatin
AUC 6, IV day 8 cycle 1 - 28 days, day 1 of subsequent cycles q 21 days x 3 cycles
Drug: bevacizumab
15 mg/kg, IV, Day 8 of cycle 1 - 28 days, day 1 of subsequent cycles q 21 days x 3 cycles
Drug: Placebo
oral, daily
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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:
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or | 1-317-615-4559 |
United States, Arkansas | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Active, not recruiting |
Bentonville, Arkansas, United States, 72712 | |
United States, Illinois | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Active, not recruiting |
Chicago, Illinois, United States, 60611 | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
Galesburg, Illinois, United States, 61401 | |
Contact: Eli Lilly | |
United States, Indiana | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Active, not recruiting |
South Bend, Indiana, United States, 46601 | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Active, not recruiting |
Muncie, Indiana, United States, 47303 | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Active, not recruiting |
Fort Wayne, Indiana, United States, 46815 | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
Bloomington, Indiana, United States, 47403 | |
Contact: Eli Lilly | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
Evansville, Indiana, United States, 47714 | |
Contact: Eli Lilly | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Contact: Eli Lilly | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
Lafayette, Indiana, United States, 47904 | |
Contact: Eli Lilly | |
United States, Michigan | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
Jackson, Michigan, United States, 49201 | |
Contact: Eli Lilly | |
United States, Nebraska | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
Omaha, Nebraska, United States, 68114 | |
Contact: Eli Lilly |
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: | 11398, H6Q-MC-S034 |
Study First Received: | September 19, 2007 |
Last Updated: | December 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00533429 |
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 Carboplatin Bevacizumab 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 Growth Substances Physiological Effects of Drugs Enzyme Inhibitors |
Folic Acid Antagonists Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |