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

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ClinicalTrials.gov Identifier: NCT02544633
Recruitment Status : Active, not recruiting
First Posted : September 9, 2015
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
Mirati Therapeutics Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: MGCD265 Phase 2

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Arm 1
MGCD265 in patients with MET activating mutations in tumor tissue
Drug: MGCD265
MGCD265 is a small molecule multi-targeted receptor tyrosine kinase inhibitor

Experimental: Arm 2
MGCD265 in patients with MET gene amplifications in tumor tissue
Drug: MGCD265
MGCD265 is a small molecule multi-targeted receptor tyrosine kinase inhibitor

Experimental: Arm 3
MGCD265 in patients with MET activating mutations in blood (circulating tumor DNA)
Drug: MGCD265
MGCD265 is a small molecule multi-targeted receptor tyrosine kinase inhibitor

Experimental: Arm 4
MGCD265 in patients with MET gene amplifications in blood (circulating tumor DNA)
Drug: MGCD265
MGCD265 is a small molecule multi-targeted receptor tyrosine kinase inhibitor




Primary Outcome Measures :
  1. Number of patients experiencing tumor size reduction [ Time Frame: Up to 3 months ]
    Tumors will be measure using radiographic scans. Tumor size reduction and overall disease response will be categorized according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1)


Secondary Outcome Measures :
  1. Number of patients experiencing adverse events [ Time Frame: Up to 12 months ]
  2. Peak blood plasma concentration of MGCD265 [ Time Frame: Up to 6 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of non-small cell lung cancer
  • Metastatic or locally advanced disease
  • Prior platinum chemotherapy or immunotherapy
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02544633


  Show 94 Study Locations
Sponsors and Collaborators
Mirati Therapeutics Inc.

Responsible Party: Mirati Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT02544633     History of Changes
Other Study ID Numbers: 265-109
First Posted: September 9, 2015    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Mirati Therapeutics Inc.:
Mirati
MGCD265
MET
NSCLC

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms