A Non-Randomized, Open-Label, Single-Arm, Phase 2 Study of LY2875358 in Patients With MET Diagnostic Positive, Advanced Gastric Cancer
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- Have previously completed or withdrawn from this study or any other study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