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

Lilly

Status and phase: Completed; Phase 2; Phase 1

Conditions: Malignant Solid Tumor; Non-Small Cell Lung Cancer

Treatments: Drug: erlotinib; Drug: enzastaurin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00452413

11183 (Registry Identifier)

H6Q-MC-S030 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

Enzastaurin and erlotinib combination therapy

Experimental group

Description:

Enzastaurin: * 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

Treatment:

Drug: enzastaurin

Drug: erlotinib