Clinical trial NCT01874938: A Study of LY2875358 in Participants With MET Positive, Advanced Gastric Cancer
Official title: A Non-Randomized, Open-Label, Single-Arm, Phase 2 Study of LY2875358 in Patients With MET Diagnostic Positive, Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2013-06-11
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Progression Free Survival (PFS) Rate
timeFrame: 8 Weeks
Secondary outcomes:
measure: Proportion of Participants who Exhibit Confirmed Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])
timeFrame: Baseline to Confirmed CR or PR (Estimated up to 4 Months)
measure: Proportion of Participants who Exhibit Stable Disease (SD) or Confirmed CR or PR (Disease Control Rate [DCR])
timeFrame: Baseline to Measured Progressive Disease or Death from Any Cause (Estimated up to 4 Months)
measure: Duration of Response
timeFrame: Date of CR or PR to Date of Measured Recurrent or Progressive Disease or Death from Any Cause (Estimated up to 4 Months)
measure: Overall Survival (OS)
timeFrame: Baseline to Death from Any Cause (Estimated up to 6 Months)
measure: Pharmacokinetics (PK): Systemic Clearance (CL) of LY287358
timeFrame: Baseline to Study Completion (Estimated up to 4 Months)
measure: Pharmacokinetics (PK): Volume of distribution (V) of LY287358
timeFrame: Baseline to Study Completion (Estimated up to 4 Months)
measure: PFS
timeFrame: Baseline to Measured Progressive Disease or Death from Any Cause (Estimated up to 6 Months)
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Osaka
country: Japan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Seoul
country: Korea, Republic of
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: