A Study of LY2875358 in Japanese Participants With Advanced Cancer
|Solid Tumors Lymphoma Carcinoma, Non-Small-Cell Lung||Biological: LY2875358 Drug: Erlotinib Drug: Gefitinib||Phase 1|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase 1 Study of LY2875358 in Japanese Patients With Advanced Malignancies|
- Number of participants with one or more drug (or procedure)-related adverse events (AEs) or any serious AEs [ Time Frame: Baseline up to 56 days after last dose of study drug ]
- Pharmacokinetics (PK): Maximum concentration (Cmax) of LY2875358, erlotinib and gefitinib [ Time Frame: Predose up to Cycle 6 ]
- Pharmacokinetics (PK): Area under the concentration time curve (AUC) of LY2875358, erlotinib and gefitinib [ Time Frame: Predose up to Cycle 6 ]
- Number of participants with a tumor response [ Time Frame: Baseline to study completion (estimated to be 5 months) ]
|Study Start Date:||June 2012|
|Study Completion Date:||August 2014|
|Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Part A. LY2875358 will be administered intravenously (IV) at escalating doses (700 mg up to 2000 mg) on Day 1 and Day 15 of a 28-day cycle, until any discontinuation criterion is met.
Part B1. Erlotinib will be administered orally at 150 mg dose level each day. LY2875358 will be administered intravenously (IV) at recommended dose level in Part A on Day 1 and Day 15 of a 28-day cycle. (Part B1 was added per protocol amendment in January, 2013.)
Part B2. Gefitinib will be administered orally at 250 mg dose level each day. LY2875358 will be administered intravenously (IV) at recommended dose level in Part A on Day 1 and Day 15 of a 28-day cycle. (Part B2 was added per protocol amendment in January, 2013.)
This study has 3 parts. Participants may only enroll in one part.
Part A - Participants will receive LY2875358.
Part B1 - Participants with non-small cell lung cancer (NSCLC) will receive LY2875358 and erlotinib.
Part B2 - Participants with NSCLC will receive LY2875358 and gefitinib.
Parts B1 and B2 were added per protocol amendment in January, 2013.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01602289
|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.|
|Chiba, Japan, 277-8577|
|Study Director:||Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)||Eli Lilly and Company|