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

Mirati Therapeutics

Status and phase: Completed; Phase 2

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: MGCD265

Study type: Interventional

Funder types: Industry

Identifiers

NCT02544633

265-109

Details and patient eligibility

About

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.

Full description

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

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 4 patient groups

Arm 1

Experimental group

Description:

MGCD265 in patients with MET activating mutations in tumor tissue

Treatment:

Drug: MGCD265

Arm 2

Experimental group

Description:

MGCD265 in patients with MET gene amplifications in tumor tissue

Treatment:

Drug: MGCD265

Arm 3

Experimental group

Description:

MGCD265 in patients with MET activating mutations in blood (circulating tumor DNA)

Treatment:

Drug: MGCD265

Arm 4

Experimental group

Description:

MGCD265 in patients with MET gene amplifications in blood (circulating tumor DNA)

Treatment:

Drug: MGCD265