A Study of LY3023414 in Japanese Participants With Advanced Cancer

Phase 1

Completed

• Conditions: Neoplasm
• Interventions: Drug: LY3023414

• Registration Number: NCT02536586
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The main purpose of this study is to evaluate the tolerability of an investigational drug known as LY3023414 in Japanese participants with advanced cancer or cancer that has spread to another part(s) of the body. The study will also explore the safety of the drug. It will measure how much of the drug gets into the blood steam and how long the body takes to get rid of it. It will investigate anti-cancer activity.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-28
• Study First Submitted QC: 2015-08-28
• Study Start: 2015-09
• Study First Posted: 2015-09-01
• Primary Completion: 2017-02-09
• Study Completion: 2017-02-09
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-20
• Last Update Posted: 2018-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LY3023414	LY3023414	LY3023414 administered orally, twice daily in 21-day cycles. Treatment will continue until disease progression, development of unacceptable toxicity, or other discontinuation criteria are met.

Primary Outcome Measures

Name	Time	Method
Number of Participants with LY3023414 Dose-Limiting Toxicities (DLT)	Cycle 1 (21 days)

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3023414	Predose Cycle 1 through predose Cycle 3. (Cycle = 21 days.)
Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve (AUC) of LY3023414	Predose Cycle 1 through predose Cycle 3. (Cycle = 21 days.)
Proportion of Participants With Best Overall Response (OR) of Partial Response (PR) or Complete Response (CR) (Overall Response Rate [ORR])	Baseline through study completion (estimated as up to five months)

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.; 🇯🇵 Tokyo, Japan