A Study of LY3039478 in Japanese Participants With Advanced Solid Tumors

Study Overview
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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.

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

Conditions
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Advanced Solid Tumor

Intervention / Treatment
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* Drug: LY3039478


Participation Criteria
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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 ≤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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3039478<br>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<br>* Administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3039478 |  | Cycle 1 Day 1 through Cycle 2 Day 1 (28 day cycles) | 
| PK: Area Under the Curve (AUC) 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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notch inhibitor