A Study of LY2875358 in Participants With MET Positive, Advanced Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01874938
• Other study ID #: 15007
• Secondary ID: I4C-JE-JTBE
• Status: Completed
• Phase: Phase 2
• First received: May 22, 2013
• Last updated: January 7, 2015
• Start date: August 2013
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareJapan: Pharmaceuticals and Medical Devices AgencySouth Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Biological:
• LY2875358
Administered IV

Locations

Country	Name	City	State
Japan	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.	Aichi
Japan	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.	Osaka
Korea, Republic of	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.	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

Japan,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS) Rate		8 Weeks	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	Overall Survival (OS)		Baseline to Death from Any Cause (Estimated up to 6 Months)	No
Secondary	Pharmacokinetics (PK): Systemic Clearance (CL) of LY287358		Baseline to Study Completion (Estimated up to 4 Months)	No
Secondary	Pharmacokinetics (PK): Volume of distribution (V) of LY287358		Baseline to Study Completion (Estimated up to 4 Months)	No
Secondary	PFS		Baseline to Measured Progressive Disease or Death from Any Cause (Estimated up to 6 Months)	No