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A Non-Randomized, Open-Label, Single-Arm, Phase 2 Study of LY2875358 in Patients With MET Diagnostic Positive, Advanced Gastric Cancer

Phase 2
20 Years
Not Enrolling
Gastric Cancer

Thank you

Trial Information

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

- 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)

- 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- Have previously completed or withdrawn from this study or any other study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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS)

Outcome Time Frame:

Baseline to Measured Progressive Disease or Death from Any Cause (Estimated up to 6 Months)

Safety Issue:


Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

August 2013

Completion Date:

August 2014

Related Keywords:

  • Gastric Cancer
  • Stomach Neoplasms