I4C-JE-JTBE

Phase 2

Completed

• Conditions: Stomach Neoplasms

• Registration Number: JPRN-jRCT2080222178
• Lead Sponsor: Eli Lilly Japan K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-21
• Study Completion: 2015-05-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Have a diagnosis of a histopathologically or cytologically confirmed gastric or GEJ adenocarcinoma
-Have received 2 regimens of prior chemotherapies for gastric or GEJ adenocarcinoma
- Determined to be MET diagnostic (+) by the Lilly central laboratory based upon testing of a tumor sample obtained at any time before enrollment.
- Women of child-bearing potential who test negative for pregnancy ≤14 days before enrollment based on a serum pregnancy test and agree to use a reliable method of birth control during the study and for 4 months following the last dose of the study drug and must also not be breastfeeding.

Exclusion Criteria

-Are currently enrolled in, or discontinued within the last 21 days from, a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
-Have previously completed or withdrawn from this study or any other study investigating LY2875358
-Have an active fungal, bacterial, and/or known viral infection
-Have a history of New York Heart Association class more than 3, unstable angina, myocardial infarction (MI) in 6 months prior to study drug administration
-Have symptomatic central nervous system (CNS) malignancy or metastasis
-Have previous or concurrent malignancies
-Have received a liver transplant, or have liver cirrhosis with a Child-Pugh Stage of B or C
-Have corrected QT interval (QTc) of 470 millisecond (msec) on screening electrocardiogram (ECG)
-Have received previous treatment with any hepatocyte growth factor (HGF)/MET targeting therapeutics
-Have a history of radiation therapy involving more than 25% of the bone marrow. Previous radiation therapy is allowed but should have been limited and must not have included whole pelvis radiation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>Progression Free Survival(PFS)Rate(Time Frame:8 Weeks)

Secondary Outcome Measures

Name	Time	Method
safety<br>exploratory<br>pharmacokinetics<br>pharmacodynamics<br>pharmacogenomics<br>other<br>-ORR<br>-DCR<br>-Duration of response<br>-OS<br>-PFS<br>-PK<br>-PD