A Study of LY3039478 in Japanese Participants With Advanced Solid Tumors

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-09

Study Completion Date

2023-05-30

Brief Summary

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

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Detailed Description

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Conditions

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Advanced Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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25 mg LY3039478

Participants received 25 milligrams (mg) of LY3039478, administered orally three times per week (TIW) in a 28-day cycle, until disease progression, development of unacceptable toxicity, or any other discontinuation criteria were met.

Group Type EXPERIMENTAL

LY3039478

Intervention Type DRUG

Administered orally

50 mg LY3039478

Participants received 50 mg of LY3039478, administered orally TIW in a 28-day cycle, until disease progression, development of unacceptable toxicity, or any other discontinuation criteria were met.

Group Type EXPERIMENTAL

LY3039478

Intervention Type DRUG

Administered orally

Interventions

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LY3039478

Administered orally

Intervention Type DRUG

Eligibility Criteria

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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 less than or equal to (≤) 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
* Adequate organ function, including hematologic, hepatic, and renal.
* Estimated life expectancy of greater than or equal to (≥) 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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No