Overview

This trial is active, not recruiting.

Condition gastric cancer
Treatment ly2875358
Phase phase 2
Target c-MET
Sponsor Eli Lilly and Company
Start date August 2013
End date August 2014
Trial size 15 participants
Trial identifier NCT01874938, 15007, I4C-JE-JTBE

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
LY2875358 will be administered intravenously (IV) at 2000 milligram (mg) bi-weekly in 28 day Cycle.
ly2875358
Administered IV

Primary Outcomes

Measure
Progression Free Survival (PFS) Rate
time frame: 8 Weeks

Secondary Outcomes

Measure
Proportion of Participants who Exhibit Confirmed Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])
time frame: 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])
time frame: Baseline to Measured Progressive Disease or Death from Any Cause (Estimated up to 4 Months)
Duration of Response
time frame: 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)
time frame: Baseline to Death from Any Cause (Estimated up to 6 Months)
Pharmacokinetics (PK): Systemic Clearance (CL) of LY287358
time frame: Baseline to Study Completion (Estimated up to 4 Months)
Pharmacokinetics (PK): Volume of distribution (V) of LY287358
time frame: Baseline to Study Completion (Estimated up to 4 Months)
PFS
time frame: Baseline to Measured Progressive Disease or Death from Any Cause (Estimated up to 6 Months)

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

Official title A Non-Randomized, Open-Label, Single-Arm, Phase 2 Study of LY2875358 in Patients With MET Diagnostic Positive, Advanced Gastric Cancer
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.