Trial · NCT02544633

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

NCT02544633, Phase 2, Completed, Mirati Therapeutics Inc.; results first posted 2019-09-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase 2 Study of MGCD265 in Patients With Non-Small Cell Lung Cancer With Activating Genetic Alterations in MET. Trials, record NCT02544633. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02544633

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Phase 2 Study of MGCD265 in Patients With Non-Small Cell Lung Cancer With Activating Genetic Alterations in MET
NCT number: NCT02544633
Status: Completed
Phases: Phase 2
Enrollment: 68 participants, actual
Lead sponsor: Mirati Therapeutics Inc.
Conditions: Non-Small Cell Lung Cancer
Interventions: MGCD265
First posted: 2015-09-09
Last updated: 2020-03-04
Results first posted: 2019-09-10
Limitations and caveats: Early closure of the study is due to sponsor portfolio prioritization and not due to any patient safety issues.

Source ClinicalTrials.gov

Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Objective Response Rate	Up to 3 months	Objective disease response is defined as the percent of patients documented by investigator assessment to have a confirmed Complete Response (CR) or Partial Response (PR) in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for target and non-target lesions as assessed by CT or MRI. CR is defined as complete disappearance of all target lesions with the exception of nodal disease; PR is defined as \>=30% decrease under baseline of the sum of diameters of all target measurable lesions; Stable Disease (SD) is concluded when the response does not qualify for CR, PR or Progression; Progressive Disease (PD) is defined as a 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions.
Secondary	Duration of Response	From date of the first documentation of objective tumor response (CR or PR) to the first documentation of Objective Progression of Disease (PD) or to death due to any cause in the absence of documented PD, assessed up to 24 months.	Duration of Response (DR) will be defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of Objective Progression of Disease (PD) or to death due to any cause in the absence of documented PD.
Secondary	Progression Free Survival	The time from date of first study treatment to first PD or death due to any cause in the absence of documented PD, up to 24 months.	Progression-free survival (PFS) will be defined as the time from date of first study treatment to first PD or death due to any cause in the absence of documented PD. Per RECIST 1.1, Progressive Disease (PD) is defined as a 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions.
Secondary	1-Year Survival Rate	From date of first study treatment to death due to any cause, assessed up to 12 months	1-Year Survival will be defined as the probability of survival at 1 year after the first dose.
Secondary	Overall Survival	From date of first study treatment to death due to any cause, assessed up to 24 months.	Overall Survival will be defined as the time from date of first study treatment to death due to any cause
Secondary	Number of Patients Experiencing Treatment-emergent Adverse Events	Date of first dose to 28 days after the last dose, up to an average of 5.1 months on treatment.	Number of patients experiencing treatment-emergent adverse events.
Secondary	Blood Plasma Concentration of MGCD265 - AUC0-6	Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose.	Blood samples for PK assessment were to be taken on Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. The number of patients reported for each PK parameter was dependent on the actual number of blood samples collected post-dose.
Secondary	Blood Plasma Concentration of MGCD265 - Cmax	Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. Cycle 2, Day 1 and Day 15 at pre-dose and at 6 hours post-dose (4-8 hours).	Blood samples for PK assessment were to be taken on Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. On Cycle 2, samples were collected on Day 1 and Day 15 at pre-dose and at 6 hours post-dose (4-8 hours). Note: Assessment of Cmax and Tmax are limited by the sparse blood sampling schedule post dose (i.e., only 2 blood draws post-dose in Cycle 1 and only 1 sample collected post-dose in Cycle 2). The number of patients reported for each PK parameter was dependent on the actual number of blood samples collected post-dose.
Secondary	Blood Plasma Concentration of MGCD265 - Ctrough	Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. Cycle 2, Day 1 and Day 15 at pre-dose and at 6 hours post-dose (4-8 hours).	Blood samples for PK assessment were to be taken on Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. On Cycle 2, samples were collected on Day 1 and Day 15 at pre-dose and at 6 hours post-dose (4-8 hours). The number of patients reported for each PK parameter was dependent on the actual number of blood samples collected post-dose.
Secondary	Blood Plasma Concentration of MGCD265 - Accumulation Ratio AUC0-6	Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose.	Blood samples for PK assessment were to be taken on Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. The number of patients reported for each PK parameter was dependent on the actual number of blood samples collected post-dose. Accumulation Ratio AUC0-6 = AUC0-6 C1D15/ AUC0-6 C1D1.

1 to 10 of 17Source ClinicalTrials.gov

See all 17 registered outcomes

Outcomes17

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Objective Response Rate	Up to 3 months	Modified Intent-to-Treat (mITT) Population defined as all patients who received at least one dose of MGCD265	percentage of participants	NUMBER
SECONDARY	Duration of Response	From date of the first documentation of objective tumor response (CR or PR) to the first documentation of Objective Progression of Disease (PD) or to death due to any cause in the absence of documented PD, assessed up to 24 months.	Modified Intent-to-Treat (mITT) Population defined as all patients who received at least one dose of MGCD265	days	MEDIAN
SECONDARY	Progression Free Survival	The time from date of first study treatment to first PD or death due to any cause in the absence of documented PD, up to 24 months.	Modified Intent-to-Treat (mITT) Population defined as all patients who received at least one dose of MGCD265	months	MEDIAN
SECONDARY	1-Year Survival Rate	From date of first study treatment to death due to any cause, assessed up to 12 months	Modified Intent-to-Treat (mITT) Population defined as all patients who received at least one dose of MGCD265	percentage	NUMBER
SECONDARY	Overall Survival	From date of first study treatment to death due to any cause, assessed up to 24 months.	Modified Intent-to-Treat (mITT) Population defined as all patients who received at least one dose of MGCD265	months	MEDIAN
SECONDARY	Number of Patients Experiencing Treatment-emergent Adverse Events	Date of first dose to 28 days after the last dose, up to an average of 5.1 months on treatment.	Safety population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Blood Plasma Concentration of MGCD265 - AUC0-6	Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose.	PK Analysis Set consisted of all patients who received at least one dose of active study drug and had sufficient data to assess any of the PK parameters.	h*ng/mL	GEOMETRIC_MEAN
SECONDARY	Blood Plasma Concentration of MGCD265 - Cmax	Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. Cycle 2, Day 1 and Day 15 at pre-dose and at 6 hours post-dose (4-8 hours).	PK Analysis Set consisted of all patients who received at least one dose of active study drug and had sufficient data to assess any of the PK parameters. No results are reported for C2D15 because the number of observations were less than 3 for the 1050 mg BID (Soft Gel Capsule).	ng/mL	GEOMETRIC_MEAN
SECONDARY	Blood Plasma Concentration of MGCD265 - Ctrough	Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. Cycle 2, Day 1 and Day 15 at pre-dose and at 6 hours post-dose (4-8 hours).	PK Analysis Set consisted of all patients who received at least one dose of active study drug and had sufficient data to assess any of the PK parameters. No results are reported for C2D15 because the number of observations were less than 3 for the 1050 mg BID (Soft Gel Capsule).	ng/mL	GEOMETRIC_MEAN
SECONDARY	Blood Plasma Concentration of MGCD265 - Accumulation Ratio AUC0-6	Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose.	PK Analysis Set consisted of all patients who received at least one dose of active study drug and had sufficient data to assess any of the PK parameters.	ratio	GEOMETRIC_MEAN

1 to 10 of 17Source ClinicalTrials.gov

See all 17 outcomes

Results by group89

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Objective Response Rate	MET Activating Mutations in Tumor Tissue	10.7	95% Confidence Interval 2.27 to 28.23	percentage of participants
Objective Response Rate	MET Gene Amplifications in Tumor Tissue	15.0	95% Confidence Interval 3.21 to 37.89	percentage of participants
Objective Response Rate	MET Activating Mutations in ctDNA	25.0	95% Confidence Interval 3.19 to 65.09	percentage of participants
Objective Response Rate	MET Gene Amplifications in ctDNA	0.0	95% Confidence Interval 0.00 to 26.46	percentage of participants
Duration of Response	MET Activating Mutations in Tumor Tissue	85	95% Confidence Interval 82 to 132	days
Duration of Response	MET Gene Amplifications in Tumor Tissue	170	95% Confidence Interval 120 to 170	days
Duration of Response	MET Activating Mutations in ctDNA	NA	95% Confidence Interval 77 to NA	days
Progression Free Survival	MET Activating Mutations in Tumor Tissue	3.95	95% Confidence Interval 2.11 to 4.18	months
Progression Free Survival	MET Gene Amplifications in Tumor Tissue	4.84	95% Confidence Interval 1.35 to 5.53	months
Progression Free Survival	MET Activating Mutations in ctDNA	3.39	95% Confidence Interval 1.28 to NA	months

1 to 10 of 89Source ClinicalTrials.gov

See all 89 results by group

Participant flow24

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Treatment Period	STARTED	MET Activating Mutations in Tumor Tissue	28
Treatment Period	STARTED	MET Gene Amplifications in Tumor Tissue	20
Treatment Period	STARTED	MET Activating Mutations in ctDNA	8
Treatment Period	STARTED	MET Gene Amplifications in ctDNA	12
Treatment Period	COMPLETED	MET Activating Mutations in Tumor Tissue	0
Treatment Period	COMPLETED	MET Gene Amplifications in Tumor Tissue	0
Treatment Period	COMPLETED	MET Activating Mutations in ctDNA	0
Treatment Period	COMPLETED	MET Gene Amplifications in ctDNA	0
Treatment Period	NOT COMPLETED	MET Activating Mutations in Tumor Tissue	28
Treatment Period	NOT COMPLETED	MET Gene Amplifications in Tumor Tissue	20

1 to 10 of 24Source ClinicalTrials.gov

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Adverse events990

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	MET Activating Mutations in Tumor Tissue	3	28
other	Anaemia	Blood and lymphatic system disorders	MET Gene Amplifications in Tumor Tissue	1	20
other	Anaemia	Blood and lymphatic system disorders	MET Activating Mutations in ctDNA	1	8
other	Anaemia	Blood and lymphatic system disorders	MET Gene Amplifications in ctDNA	1	12
other	Anaemia	Blood and lymphatic system disorders	Total	6	68
other	Iron deficiency anaemia	Blood and lymphatic system disorders	MET Activating Mutations in Tumor Tissue	0	28
other	Iron deficiency anaemia	Blood and lymphatic system disorders	MET Gene Amplifications in Tumor Tissue	0	20
other	Iron deficiency anaemia	Blood and lymphatic system disorders	MET Activating Mutations in ctDNA	0	8
other	Iron deficiency anaemia	Blood and lymphatic system disorders	MET Gene Amplifications in ctDNA	1	12
other	Iron deficiency anaemia	Blood and lymphatic system disorders	Total	1	68

1 to 10 of 990Source ClinicalTrials.gov

See all 990 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	MET Activating Mutations in Tumor Tissue	12	28
Total, all-cause mortality	MET Gene Amplifications in Tumor Tissue	14	20
Total, all-cause mortality	MET Activating Mutations in ctDNA	3	8
Total, all-cause mortality	MET Gene Amplifications in ctDNA	9	12
Total, all-cause mortality	Total	38	68
Total, other adverse events	MET Activating Mutations in Tumor Tissue	28	28
Total, other adverse events	MET Gene Amplifications in Tumor Tissue	20	20
Total, other adverse events	MET Activating Mutations in ctDNA	7	8
Total, other adverse events	MET Gene Amplifications in ctDNA	12	12
Total, other adverse events	Total	67	68

1 to 10 of 15Source ClinicalTrials.gov

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Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
36459255	DERIVED	PubMed
38417277	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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