A Study of LY3039478 in Japanese Participants With Advanced Solid Tumors

January 10, 2024 updated by: Eli Lilly and Company

A Phase 1 Study of LY3039478 in Japanese Patients With Advanced Solid Tumors

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Chiba
      • Kashiwa, Chiba, Japan, 277 8577
        • 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: LY3039478
Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with LY3039478 Dose-Limiting Toxicities (DLTs)
Time Frame: Cycle 1 (28 days)
Cycle 1 (28 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3039478
Time Frame: Cycle 1 Day 1 through Cycle 2 Day 1 (28 day cycles)
Cycle 1 Day 1 through Cycle 2 Day 1 (28 day cycles)
PK: Area Under the Curve (AUC) of LY3039478
Time Frame: Cycle 1 Day 1 through Cycle 2 Day 1 (28 day cycles)
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)
Time Frame: Baseline through Disease Progression or Death (estimated at up to 9 months)
Baseline through Disease Progression or Death (estimated at up to 9 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2016

Primary Completion (Actual)

July 5, 2019

Study Completion (Actual)

May 30, 2023

Study Registration Dates

First Submitted

July 15, 2016

First Submitted That Met QC Criteria

July 15, 2016

First Posted (Estimated)

July 19, 2016

Study Record Updates

Last Update Posted (Actual)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16191
  • I6F-JE-JJCC (Other Identifier: Eli Lilly and Company)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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