Stomach Neoplasms
Conditions
Interventions
investigational material(s)
Generic name etc : LY2875358
INN of investigational material : Emibetuzumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigati
Sponsors
Eli Lilly Japan K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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medical research judged not to be scientifically or medically compatible with this study -Have previously completed or withdrawn from this study or any other study investigating LY2875358 -Have an active fungal, bacterial, and/or known viral infection -Have a history of New York Heart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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Progression Free Survival(PFS)Rate(Time Frame:8 Weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| safety exploratory pharmacokinetics pharmacodynamics pharmacogenomics other -ORR -DCR -Duration of response -OS -PFS -PK -PD | — |
Countries
Asia except Japan, Japan
Outcome results
None listed