Status:
COMPLETED
A Study of Enzastaurin and Erlotinib in Participants With Solid Tumors and Lung Cancer
Lead Sponsor:
Eli Lilly and Company
Conditions:
Non-Small Cell Lung Cancer
Malignant Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 can...
Eligibility Criteria
Inclusion
- Phase 1: Any incurable solid malignancy, with no more than 3 prior systemic treatment regimens.
- Phase 2: Histologic diagnosis of advanced NSCLC, Stage IIIB with malignant pleural effusion or Stage IV per American Joint Committee on Cancer Staging Criteria for NSCLC. Participants must have failed 1 or 2 prior systemic treatment regimen(s).
- Performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Scale
- Prior chemotherapy must be completed at least 2 weeks prior to study enrollment, and the participant must have recovered from acute toxic effects (except alopecia) prior to enrollment.
- Prior radiotherapy is allowed to \<25% of the bone marrow. Prior radiotherapy must be completed at least 2 weeks before study enrollment, and the participant must have recovered from acute toxic effects (except alopecia) prior to enrollment.
- Non-measurable or measurable disease as defined by Response Evaluation Criteria in Solid Tumors \[RECIST, version (v) 1.0\].
Exclusion
- Participants who
- Are unable to swallow tablets.
- Unable to discontinue use of carbamazepine, phenobarbital, and phenytoin.
- Have previously been treated with an epidermal growth factor receptor (EGFR) inhibitor, including erlotinib.
- Are receiving concurrent administration of any other antitumor therapy.
- Have received treatment within the last 30 days with a drug (not including study drug) that has not received regulatory approval for any indication at the time of study entry.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00452413
Start Date
May 1 2007
End Date
November 1 2013
Last Update
May 13 2021
Active Locations (10)
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1
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, California, United States, 90048
2
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.
Palo Alto, California, United States, 94305
3
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.
San Francisco, California, United States, 94143
4
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.
Louisville, Kentucky, United States, 40207