A Study of Enzastaurin and Erlotinib in Participants With Solid Tumors and Lung Cancer
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Eli Lilly and Company
- Study ID
- NCT00452413
- Phase
- PHASE1/PHASE2
- Status
- Completed
Conditions
- Malignant Solid Tumor
- Non-Small Cell Lung Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- enzastaurin — DRUGAdministered orally
- erlotinib — DRUGAdministered orally
Study Details
Phase I: A study to see what doses of Enzastaurin and Erlotinib are best tolerated by participants with solid tumor cancer. Phase II: A study to see how long participants with non-small cell lung cancer (NSCLC) treated with Enzastaurin and Erlotinib live.
Key Dates
- First listed
- Mar 27, 2007
- Start date
- May 31, 2007
- Status verified
- Apr 2021
- Primary completion
- Jul 31, 2009
- Completion
- Nov 30, 2013
Study Design
- Enrollment
- 65 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Enzastaurin and erlotinib combination therapyEnzastaurin: * Phase 1, Dose Level 1: 500 milligram (mg) oral loading dose Day 1, 250 mg oral, daily Day 2-28, 28-day cycle until disease progression * Phase 1, Dose Level 2: 1125 mg oral loading dose Day 1, 500 mg oral, daily until disease progression * Phase 2: Dose determined from Phase 1, oral, daily, 28-day cycles until disease progression Erlotinib: • 150 mg, oral, daily, 28-day cycles until disease progression
Primary Outcome Measure
Recommended Phase 2 Dose for Enzastaurin Plus Erlotinib Combination Therapy (Assess the Tolerated Dose of the Combination Erlotinib and Enzastaurin) [ Time Frame: Phase 1: Predose through end of Cycle 1 (28 days/cycle) ]
Locations (10)
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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.· Los Angeles, CAFor 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.· Palo Alto, CAFor 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.· San Francisco, CAFor 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.· Louisville, KYFor 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.· Baltimore, MDFor 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.· Minneapolis, MN
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