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

Lilly

Status and phase

Completed

Phase 2

Conditions

Gastric Cancer

Treatments

Biological: LY2875358

Study type

Interventional

Funder types

Industry

Identifiers

NCT01874938

15007

I4C-JE-JTBE (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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Have previously completed or withdrawn from this study or any other study investigating LY2875358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