A Study of LY3039478 in Japanese Participants With Advanced Solid Tumors

Lilly

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: LY3039478

Study type: Interventional

Funder types: Industry

Identifiers

NCT02836600

16191

I6F-JE-JJCC (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 11 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

25 mg LY3039478

Experimental group

Description:

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.

Treatment:

Drug: LY3039478

50 mg LY3039478

Experimental group

Description:

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.

Treatment:

Drug: LY3039478