Clinical Trials /

Phase 2 Study of MGCD265 in Patients With Non-Small Cell Lung Cancer With Activating Genetic Alterations in MET

NCT02544633

Description:

MGCD265 is an orally administered receptor tyrosine kinase inhibitor that targets MET and other receptors. This study is a Phase 2 trial of MGCD265 in patients with locally advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) that has activating genetic changes of the MET gene (mutation or amplification [increase number of gene copies]). Testing for tumor gene changes can be performed in tumor tissue or blood samples. Patients must have previously received treatment with chemotherapy. The number of patients to be enrolled will depend on how many enrolled patients experience tumor size reduction. MGCD265 will be administered orally, twice daily. The study is designed to evaluate whether the number of patients experiencing tumor size reduction is substantially higher than would be expected with other available treatments.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Completed

Phase:

Phase 2

Trial Eligibility

Document

Phase 2 Study of <span class="go-doc-concept go-doc-intervention">MGCD265</span> in Patients With Non-Small Cell Lung Cancer With Activating <span class="go-doc-concept go-doc-keyword">Genetic</span> Alterations in <span class="go-doc-concept go-doc-biomarker">MET</span>

Title

  • Brief Title: Phase 2 Study of MGCD265 in Patients With Non-Small Cell Lung Cancer With Activating Genetic Alterations in MET
  • Official Title: Phase 2, Parallel-Arm Study of MGCD265 in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Activating Genetic Alterations in Mesenchymal-Epithelial Transition Factor
  • Clinical Trial IDs

    NCT ID: NCT02544633

    ORG ID: 265-109

    Trial Conditions

    Non-Small Cell Lung Cancer

    Trial Interventions

    Drug Synonyms Arms
    MGCD265 Arm 1, Arm 2, Arm 3, Arm 4

    Trial Purpose

    MGCD265 is an orally administered receptor tyrosine kinase inhibitor that targets MET and
    other receptors. This study is a Phase 2 trial of MGCD265 in patients with locally advanced,
    unresectable or metastatic non-small cell lung cancer (NSCLC) that has activating genetic
    changes of the MET gene (mutation or amplification [increase number of gene copies]).
    Testing for tumor gene changes can be performed in tumor tissue or blood samples. Patients
    must have previously received treatment with chemotherapy. The number of patients to be
    enrolled will depend on how many enrolled patients experience tumor size reduction. MGCD265
    will be administered orally, twice daily. The study is designed to evaluate whether the
    number of patients experiencing tumor size reduction is substantially higher than would be
    expected with other available treatments.

    Detailed Description

    If testing has not already been performed, the study will provide for the testing.

    Trial Arms

    Name Type Description Interventions
    Arm 1 Experimental MGCD265 in patients with MET activating mutations in tumor tissue MGCD265
    Arm 2 Experimental MGCD265 in patients with MET gene amplifications in tumor tissue MGCD265
    Arm 3 Experimental MGCD265 in patients with MET activating mutations in blood (circulating tumor DNA) MGCD265
    Arm 4 Experimental MGCD265 in patients with MET gene amplifications in blood (circulating tumor DNA) MGCD265

    Eligibility Criteria

    Inclusion Criteria:

    - Diagnosis of non-small cell lung cancer

    - Metastatic or locally advanced disease

    - Prior chemotherapy

    - Test result showing genetic change in MET tumor gene

    - At least one tumor that can be measured on a radiographic scan

    Exclusion Criteria:

    - Prior treatment with inhibitor of MET or HGF

    - Prior positive test for EGFR mutation or ALK gene rearrangement

    - Uncontrolled tumor in the brain

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Number of patients experiencing tumor size reduction

    Secondary Outcome Measures

    Number of patients experiencing adverse events

    Peak blood plasma concentration of MGCD265

    Trial Keywords

    Mirati

    MGCD265

    MET

    NSCLC