Phase 2
N=68
Phase 2 Study of MGCD265 in Patients With Non-Small Cell Lung Cancer With Activating Genetic Alterations in MET
Non-Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02544633 ↗Enrolled (actual)
68
Serious AEs
48.5%
Results posted
Sep 2019
Primary outcome: Primary: Objective Response Rate — 10.7; 15.0; 25.0; 0.0 percentage of participants — p=0.94
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MGCD265 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mirati Therapeutics Inc.
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate |
10.7; 15.0; 25.0; 0.0 | 0.94 |
| SECONDARY Duration of Response |
85; 170; NA | — |
| SECONDARY Progression Free Survival |
3.95; 4.84; 3.39; 2.76 | — |
| SECONDARY 1-Year Survival Rate |
50.47; 34.92; 54.69; 13.89 | — |
| SECONDARY Overall Survival |
16.32; 7.04; NA; 4.08 | — |
| SECONDARY Number of Patients Experiencing Treatment-emergent Adverse Events |
28; 20; 8; 12 | — |
| SECONDARY Blood Plasma Concentration of MGCD265 - AUC0-6 |
250.8; 1565; 185.5; 1837 | — |
| SECONDARY Blood Plasma Concentration of MGCD265 - Cmax |
69.77; 279.2; 60.49; 328.1; 214; 138 | — |
| SECONDARY Blood Plasma Concentration of MGCD265 - Ctrough |
264; 337; 203; 255; 345 | — |
| SECONDARY Blood Plasma Concentration of MGCD265 - Accumulation Ratio AUC0-6 |
6.42; 9.88 | — |
| SECONDARY Blood Plasma Concentration of MGCD265 - Accumulation Ratio Cmax |
4.07; 5.35 | — |
| SECONDARY Blood Plasma Concentration of MGCD265 - Peak to Trough Ratio |
1.09; 1.08 | — |
| SECONDARY Blood Plasma Concentration of MGCD265 - Tmax |
6.00; 2.00; 6.00; 6.00 | — |
| SECONDARY Assess Correlation Between Selected Tumor Gene Alterations Using Different Analytical Techniques in Tumor Tissue and Circulating Tumor Deoxyribonucleic Acid (ctDNA) - MET Activating Mutations |
9; 1; 1; 0 | — |
| SECONDARY Assess Correlation Between Selected Tumor Gene Alterations Using Different Analytical Techniques in Tumor Tissue and Circulating Tumor Deoxyribonucleic Acid (ctDNA) - MET Gene Amplifications |
8; 6; 7; 0 | — |
| SECONDARY Assess Change in Genetic Alteration Status in ctDNA With MGCD265 Treatment Over Time in the Selected Population |
2; 2; 2; 1 | — |
| SECONDARY Blood Plasma Concentration of Soluble MET (sMET) Biomarker |
443494.7; 461985.2; 450112.5; 961383.1; 577631.4; 568938.8 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02544633). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.