A Study of LY3039478 in Japanese Participants With Advanced Solid Tumors

Phase 1

Completed

• Conditions: Advanced Solid Tumor
• Interventions: Drug: LY3039478

• Registration Number: NCT02836600
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The purpose of this study is to evaluate the tolerability of the study drug LY3039478 in Japanese participants with advanced solid tumors.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-15
• Study First Submitted QC: 2016-07-15
• Study First Posted: 2016-07-19
• Study Start: 2016-09-09
• Primary Completion: 2019-07-05
• Study Completion: 2023-05-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-10
• Last Update Posted: 2024-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Histological or cytological evidence of a diagnosis of solid tumor that is advanced and/or metastatic.
• In the judgment of the investigator, participants must be appropriate candidates for experimental therapy after available standard therapies have failed or for whom standard therapy is not appropriate.
• Performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.
• Adequate organ function, including hematologic, hepatic, and renal.
• Estimated life expectancy of ≥12 weeks.

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Exclusion Criteria

• Received previous therapy for cancer within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agents, respectively.
• Have serious preexisting medical conditions.
• Have current or recent (within 3 months of study drug administration) gastrointestinal disease with chronic or intermittent diarrhea.
• Have an active bacterial, fungal, and/or known viral infection.
• Have known acute or chronic leukemia or current hematologic malignancies that may affect the interpretation of results.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LY3039478	LY3039478	LY3039478 given orally TIW (3 times per week) in 28 day cycles. Treatment will continue until disease progression, development of unacceptable toxicity, or any other discontinuation criteria are met.

Primary Outcome Measures

Name	Time	Method
Number of Participants with LY3039478 Dose-Limiting Toxicities (DLTs)	Cycle 1 (28 days)

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3039478	Cycle 1 Day 1 through Cycle 2 Day 1 (28 day cycles)
Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)	Baseline through Disease Progression or Death (estimated at up to 9 months)
PK: Area Under the Curve (AUC) of LY3039478	Cycle 1 Day 1 through Cycle 2 Day 1 (28 day cycles)

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 from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇯🇵 Kashiwa, Chiba, Japan