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Trial record 2 of 7 for:    mgcd265

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

This study is currently recruiting participants.
Verified November 2017 by Mirati Therapeutics Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02544633
First Posted: September 9, 2015
Last Update Posted: November 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Mirati Therapeutics Inc.
  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.

Condition Intervention Phase
Non-Small Cell Lung Cancer Drug: MGCD265 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Mirati Therapeutics Inc.:

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

Estimated Enrollment: 200
Study Start Date: October 2015
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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


Contacts
Contact: Mirati Therapeutics Study Locator Services 1-844-356-0895 (toll free) miratistudylocator@emergingmed.com

  Show 94 Study Locations
Sponsors and Collaborators
Mirati Therapeutics Inc.
  More Information

Responsible Party: Mirati Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT02544633     History of Changes
Other Study ID Numbers: 265-109
First Submitted: September 4, 2015
First Posted: September 9, 2015
Last Update Posted: November 13, 2017
Last Verified: November 2017
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