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

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

Sponsors

Lead sponsor: Eli Lilly and Company

Source Eli Lilly and Company
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 cancer (NSCLC) treated with Enzastaurin and Erlotinib live.

Overall Status Completed
Start Date May 2007
Completion Date November 2013
Primary Completion Date July 2009
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Phase 1: Assess the tolerated dose of the combination erlotinib and enzastaurin. every cycle
Phase 2: Assess progression free survival with the combination regimen. baseline to measured progressive disease
Secondary Outcome
Measure Time Frame
Phase 1: safety and adverse event profile for enzastaurin/erlotinib combination every cycle
Evaluate pharmacokinetic interactions between enzastaurin and erlotinib cycle 1
Phase 2: overall survival baseline to date of death from any cause
Phase 2: duration of response time of response to progressive disease
Phase 2: tumor response baseline to measured tumor response
Phase 2: safety and adverse event profile every cycle
Enrollment 65
Condition
Intervention

Intervention type: Drug

Intervention name: enzastaurin

Description: Administered orally

Arm group label: Enzastaurin and erlotinib combination therapy

Other name: LY317615

Intervention type: Drug

Intervention name: erlotinib

Description: Administered orally

Arm group label: Enzastaurin and erlotinib combination therapy

Eligibility

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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5PM Eastern time (UTC/GMT- 5 hours, EST) Study Director Eli Lilly and Company
Location
facility
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, 90048, United States
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, 94305, United States
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, 94143, United States
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, 40207, United States
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. | Baltimore, Maryland, 21237, United States
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. | Minneapolis, Minnesota, 55455, United States
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. | Omaha, Nebraska, 68131, United States
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. | Portland, Oregon, 97213, United States
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. | Memphis, Tennessee, 38104, United States
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. | Lubbock, Texas, 79410, United States
Location Countries

United States

Verification Date

November 2016

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Enzastaurin and erlotinib combination therapy

Arm group type: Experimental

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

Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov