NCT01874938

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2 gastric-cancer

Timeline
Completed

Started Aug 2013

Shorter than P25 for phase_2 gastric-cancer

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 11, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 16, 2015

Status Verified

January 1, 2015

Enrollment Period

1 year

First QC Date

May 22, 2013

Last Update Submit

January 7, 2015

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival (PFS) Rate

    8 Weeks

Secondary Outcomes (7)

  • 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)

  • 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)

  • Pharmacokinetics (PK): Systemic Clearance (CL) of LY287358

    Baseline to Study Completion (Estimated up to 4 Months)

  • +2 more secondary outcomes

Study Arms (1)

LY2875358

EXPERIMENTAL

LY2875358 will be administered intravenously (IV) at 2000 milligram (mg) bi-weekly in 28 day Cycle.

Biological: LY2875358

Interventions

LY2875358BIOLOGICAL

Administered IV

LY2875358

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

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, 464-8681, Japan

Location

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, 565-0871, Japan

Location

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, 135 720, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

emibetuzumab

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2013

First Posted

June 11, 2013

Study Start

August 1, 2013

Primary Completion

August 1, 2014

Study Completion

December 1, 2014

Last Updated

January 16, 2015

Record last verified: 2015-01

Locations

KR(1)JP(2)