A Study of LY2875358 in Participants With MET Positive, Advanced Gastric Cancer

Study Overview
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Brief Summary
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The main purpose of this study is to evaluate the effectiveness of LY2875358 in participants with MET diagnostic positive (+), advanced gastric or gastroesophageal junction (GEJ) cancer.

Official Title
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A Non-Randomized, Open-Label, Single-Arm, Phase 2 Study of LY2875358 in Patients With MET Diagnostic Positive, Advanced Gastric Cancer

Conditions
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Gastric Cancer

Intervention / Treatment
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* Biological: LY2875358


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a diagnosis of a histopathologically or cytologically confirmed local and/or advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma which is unresectable Have received 2 regimens of prior chemotherapies for gastric or GEJ adenocarcinoma Have the presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) Have consent to provide a tissue sample for pre-screening Determined to be MET diagnostic positive based upon testing of a tumor sample obtained at any time before enrollment Have discontinued all previous treatments for cancer, including chemotherapy and radiotherapy, for at least 3 weeks before enrollment and have recovered from the acute effects of therapy Have adequate organ function Male participants: must agree to use a reliable method of birth control and to not donate sperm during the study and for at least 4 months following last dose of study drug or country requirements, whichever is longer Female participants: are 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 Have a performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale Have an estimated life expectancy, in the judgment of the investigator, of at least 12 weeks 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 ≥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

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: LY2875358<br>LY2875358 will be administered intravenously (IV) at 2000 milligram (mg) bi-weekly in 28 day Cycle. | Biological: LY2875358<br>* Administered IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) Rate |  | 8 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants who Exhibit Confirmed Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR]) |  | Baseline to Confirmed CR or PR (Estimated up to 4 Months) | 
| Proportion of Participants who Exhibit Stable Disease (SD) or Confirmed CR or PR (Disease Control Rate [DCR]) |  | Baseline to Measured Progressive Disease or Death from Any Cause (Estimated up to 4 Months) | 
| Duration of Response |  | Date of CR or PR to Date of Measured Recurrent or Progressive Disease or Death from Any Cause (Estimated up to 4 Months) | 
| Overall Survival (OS) |  | Baseline to Death from Any Cause (Estimated up to 6 Months) | 
| Pharmacokinetics (PK): Systemic Clearance (CL) of LY287358 |  | Baseline to Study Completion (Estimated up to 4 Months) | 
| Pharmacokinetics (PK): Volume of distribution (V) of LY287358 |  | Baseline to Study Completion (Estimated up to 4 Months) | 
| PFS |  | Baseline to Measured Progressive Disease or Death from Any Cause (Estimated up to 6 Months) |