Gastric Cancer
Conditions
Brief 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.
Interventions
BIOLOGICALLY2875358
Administered IV
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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medical research judged not to be scientifically or medically compatible with this study * Have previously completed or withdrawn from this study or any other study investigating LY2875358 * Have an active fungal, bacterial, and/or known viral infection * Have a history of New York Heart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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS) Rate | 8 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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) |
| 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) |
| 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) |
| Pharmacokinetics (PK): Systemic Clearance (CL) of LY287358 | Baseline to Study Completion (Estimated up to 4 Months) |
Countries
Japan, South Korea
Outcome results
None listed