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Completed

NCT Number: NCT01874938

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary 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., Aichi, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY2875358

Biological

Administered IV

Primary outcomes

  1. Progression Free Survival (PFS) Rate

    Time frame: 8 Weeks

Secondary outcomes

  1. Proportion of Participants who Exhibit Confirmed Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])

    Time frame: Baseline to Confirmed CR or PR (Estimated up to 4 Months)

  2. Proportion of Participants who Exhibit Stable Disease (SD) or Confirmed CR or PR (Disease Control Rate [DCR])

    Time frame: Baseline to Measured Progressive Disease or Death from Any Cause (Estimated up to 4 Months)

  3. Duration of Response

    Time frame: Date of CR or PR to Date of Measured Recurrent or Progressive Disease or Death from Any Cause (Estimated up to 4 Months)

  4. Overall Survival (OS)

    Time frame: Baseline to Death from Any Cause (Estimated up to 6 Months)

  5. Pharmacokinetics (PK): Systemic Clearance (CL) of LY287358

    Time frame: Baseline to Study Completion (Estimated up to 4 Months)

  6. Pharmacokinetics (PK): Volume of distribution (V) of LY287358

    Time frame: Baseline to Study Completion (Estimated up to 4 Months)

  7. PFS

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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 11, 2013
Registry last updated
Jan 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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