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A Study of Enzastaurin and Erlotinib in Participants With Solid Tumors and Lung Cancer
Trial ID: NCT00452413
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.
A Phase 1/2 Trial of Enzastaurin and Erlotinib in Patients With Advanced Solid Tumors and Non-Small Cell Lung Cancer (NSCLC) After Prior Chemotherapy
1. Phase 1: Any incurable solid malignancy, with no more than 3 prior systemic treatment
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).
2. Performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG)
3. 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
4. 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.
5. Non-measurable or measurable disease as defined by Response Evaluation Criteria in
Solid Tumors [RECIST, version (v) 1.0].
1. Are unable to swallow tablets.
2. Unable to discontinue use of carbamazepine, phenobarbital, and phenytoin.
3. Have previously been treated with an epidermal growth factor receptor (EGFR)
inhibitor, including erlotinib.
4. Are receiving concurrent administration of any other antitumor therapy.
5. 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
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Melanie San Pedro-Salcedo