A Study of LY3039478 in Japanese Participants With Advanced Solid Tumors

Advanced Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02836600
• Other study ID #: 16191
• Secondary ID: I6F-JE-JJCC
• Status: Completed
• Phase: Phase 1
• Start date: September 9, 2016
• Est. completion date: May 30, 2023

Study information

• Verified date: January 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: May 30, 2023
• Est. primary completion date: July 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• LY3039478
Administered orally

Locations

Country	Name	City	State
Japan	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with LY3039478 Dose-Limiting Toxicities (DLTs)		Cycle 1 (28 days)
Secondary	Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3039478		Cycle 1 Day 1 through Cycle 2 Day 1 (28 day cycles)
Secondary	PK: Area Under the Curve (AUC) of LY3039478		Cycle 1 Day 1 through Cycle 2 Day 1 (28 day cycles)
Secondary	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)