Overview

This trial has been completed.

Conditions non-small cell lung cancer, malignant solid tumor
Treatments enzastaurin, erlotinib
Phase phase 1/phase 2
Target EGFR
Sponsor Eli Lilly and Company
Start date May 2007
End date July 2009
Trial size 65 participants
Trial identifier NCT00452413, 11183, H6Q-MC-S030

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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
enzastaurin LY317615
Administered orally
erlotinib
Administered orally

Primary Outcomes

Measure
Phase 1: Assess the tolerated dose of the combination erlotinib and enzastaurin.
time frame: every cycle
Phase 2: Assess progression free survival with the combination regimen.
time frame: baseline to measured progressive disease

Secondary Outcomes

Measure
Phase 1: safety and adverse event profile for enzastaurin/erlotinib combination
time frame: every cycle
Evaluate pharmacokinetic interactions between enzastaurin and erlotinib
time frame: cycle 1
Phase 2: overall survival
time frame: baseline to date of death from any cause
Phase 2: duration of response
time frame: time of response to progressive disease
Phase 2: tumor response
time frame: baseline to measured tumor response
Phase 2: safety and adverse event profile
time frame: every cycle

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.