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Completed

NCT Number: NCT02836600

A Study of LY3039478 in Japanese Participants 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.

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Key information

Conditions

Advanced Solid Tumor

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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, 277 8577, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LY3039478

Drug

Administered orally

Primary outcomes

  1. Number of Participants With LY3039478 Dose-Limiting Toxicities (DLTs)

    Time frame: Cycle 1 (Up to 28 Days)

    DLT was defined as an adverse event (AE) that occurred during Cycle 1 (first 28 days) related to the study drug and met one of the following criteria per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. These criteria included: CTCAE Grade greater than or equal to (≥) 3 non-hematological toxicity, with exceptions for nausea, vomiting, or constipation, and asymptomatic electrolyte disturbances that can be controlled with standard treatment; Grade 4 hematological toxicity of greater than (>) 5 days duration; Grade ≥ 3 anemia requiring transfusion; any febrile neutropenia; neutropenia needing granulocyte-colony stimulating factors (GCSFs); Grade 3 thrombocytopenia with bleeding or requiring platelet transfusion; Grade 4 thrombocytopenia.

Secondary outcomes

  1. Overall Response Rate (ORR): Percentage of Participants Who Achieved a Complete Response (CR) or Partial Response (PR)

    Time frame: Baseline through Measured Progressive Disease (Up To 100 Weeks)

    • The ORR was defined as the percentage of participants achieving either a CR or PR. Tumor response was assessed based on histology: Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) was used for solid tumors, and Response Assessment in Neuro-Oncology criteria were used for glioblastoma.
    • CR was defined as the disappearance of all target lesions, with any pathological lymph nodes (whether target or non-target) showing a reduction in the short axis to <10 mm. Additionally, tumor marker results were required to have normalized. PR was defined as a decrease of at least 30% in the sum of the diameters of target lesions, using baseline diameters as the reference.

  2. Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3039478

    Time frame: Cycle 1, Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, and 24 hours post-dose); Cycle 1 Day 22 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, and 24 hours post-dose)

    PK: Cmax of LY3039478 was reported.

  3. PK: Area Under the Plasma Concentration-Time Curve (AUC) From 0 to 24 Hours (AUC (0-24)) of LY3039478

    Time frame: Cycle 1, Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, and 24 hours post-dose); Cycle 1 Day 22 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, and 24 hours post-dose)

    PK: AUC (0-24) of LY3039478 was reported.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2023
First posted
Jul 19, 2016
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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