A Study of LY2584702 in Solid Tumors
The purpose of this study is to assess the safety and tolerability of LY2584702 in Japanese patients with advanced and/or metastatic solid tumors for which no proven effective therapy exists.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1 Study of LY2584702 in Japanese Patients With Solid Tumors|
- Number of participants with clinically significant effects [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Pharmacokinetics, area under the concentration time curve (AUC) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Number of participants with tumor response. [ Time Frame: Baseline to study completion ] [ Designated as safety issue: No ]
- Pharmacokinetics, maximum concentration (Cmax) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
|Study Start Date:||November 2010|
|Study Completion Date:||November 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Dose escalation starting at 50 mg. On day 1, subjects will receive a single oral dose. After a two day observation period, subjects will receive oral doses twice daily for a 28 day cycle.
Patients may continue 28 day cycles of twice daily dosing until discontinuation criteria are met.
|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.|
|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|