A Study of Enzastaurin and Erlotinib in Participants With Solid Tumors and Lung Cancer

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

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 cancer (NSCLC) treated with Enzastaurin and Erlotinib live.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Erlotinib Hydrochloride

Criteria

Inclusion Criteria:

1. 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).

2. Performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Scale

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 to enrollment.

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].

Exclusion Criteria:

Participants who

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 entry.