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

February 19, 2020 updated by: Mirati Therapeutics Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Bedford Park, Australia, 5042
        • Flinders Medical Centre
      • Clayton, Australia, 3165
        • Monash Health
      • Tweed Heads, Australia, 2485
        • The Tweed Hospital
      • Woolloongabba, Australia, 4102
        • Princess Alexandra Hospital
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Concord Repatriation General Hospital
      • Kogarah, New South Wales, Australia, 2217
        • Saint George Hospital
      • Saint Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Royal Hobart Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3165
        • Monash Cancer Centre
      • Heidelberg, Victoria, Australia, 3084
        • Austin Health
  • Canada
      • Montréal, Canada, H2W 1S6
        • McGill University Health Centre
  • Hungary
      • Budapest, Hungary, 1121
        • Orszagos Koranyi Tbc es Pulmonologiai Intezet
      • Budapest, Hungary, 1122
        • Orszagos Onkologiai Intezet
      • Budapest, Hungary, 1125
        • Semmelweis Egyetem
    • Komarom-esztergom
      • Tatabánya, Komarom-esztergom, Hungary, 2800
        • Szent Borbala Korhaz
  • Italy
      • Firenze, Italy, 50139
        • Azienda Ospedaliero-Universitaria Careggi
      • Lucca, Italy, 55041
        • Ospedale Unico Versilia
      • Milano, Italy, 20132
        • Ospedale San Raffaele
      • Milano, Italy, 20132
        • Irccs Ospedale San Raffaele
      • Milano, Italy, 20132
        • Istituto Europeo di Oncologia Milano
      • Piacenza, Italy, 29100
        • Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto
      • Ravenna, Italy, 48121
        • Azienda Unita Sanitaria Locale Di Ravenna
      • Torino, Italy, 10126
        • Azienda Ospedaliera Città della Salute e della Scienza di Torino
  • Korea, Republic of
      • Daegu, Korea, Republic of, 700-712
        • Keimyung University Dongsan Medical Center
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 120-752
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 134-791
        • Veterans Health Service Medical Center
    • Chungcheongbuk-do
      • Cheongju, Chungcheongbuk-do, Korea, Republic of, 361-271
        • Chungbuk National University Hospital
    • Gyeonggi-do
      • Goyang, Gyeonggi-do, Korea, Republic of, 410-769
        • National Cancer Center
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital
      • Suwon-si, Gyeonggi-do, Korea, Republic of, 442-723
        • Saint Vincent Hospital
      • Suwon-si, Gyeonggi-do, Korea, Republic of, 442-723
        • The Catholic University of Korea Saint Vincent's Hospital
  • Poland
    • Pomorskie
      • Gdańsk, Pomorskie, Poland, 80-952
        • Uniwersyteckie Centrum Kliniczne
    • Warminsko-mazurskie
      • Olsztyn, Warminsko-mazurskie, Poland, 10-357
        • Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc w Olsztynie
    • Wielkopolskie
      • Poznan, Wielkopolskie, Poland, 60-693
        • Med Polonia Sp. z o.o.
  • Taiwan
      • Hualien City, Taiwan, 970
        • Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Medical University Hospital
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
    • Tainan
      • Tainan City, Tainan, Taiwan, 73657
        • Chi Mei Hospital Liouying
    • Tainan CITY
      • Tainan, Tainan CITY, Taiwan, 70403
        • National Cheng Kung University
  • United Kingdom
      • London, United Kingdom, NW3 2QG
        • Royal Free London NHS Foundation Trust
    • England
      • Bristol, England, United Kingdom, BS10 5NB
        • North Bristol NHS Trust, Westbury on Trym
      • London, England, United Kingdom, NW1 2PQ
        • University College London Hospitals Nhs Foundation Trust
      • Northwood, England, United Kingdom, HA6 2RN
        • East and North Hertordshire NHS Trust
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
      • Huntsville, Alabama, United States, 35805
        • Clearview Cancer Institute
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Fowler Family Center for Cancer Care
    • California
      • Burbank, California, United States, 91505
        • Providence Saint Joseph Medical Center
      • Fullerton, California, United States, 92835-3825
        • Saint Joseph Heritage Healthcare
      • La Jolla, California, United States, 92121
        • University of California San Diego
      • Loma Linda, California, United States, 92354
        • Loma Linda University Medical Center
      • San Francisco, California, United States, 94143
        • University of California, San Francisco
      • Whittier, California, United States, 90603
        • Innovative Clinical Reseach Institute
    • Colorado
      • Grand Junction, Colorado, United States, 81501
        • St. Mary's Regional Cancer Center
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Eastern Connecticut Hematology and Oncology Associates
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Medical Center
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Boca Raton Regional Hospital - Eugene M. & Christine E. Lynn Cancer Institute
      • Deerfield Beach, Florida, United States, 33442-7753
        • Sylvester Comprehensive Cancer Center
      • Fort Myers, Florida, United States, 33916
        • Florida Cancer Specialists
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Medical Center
      • Pembroke Pines, Florida, United States, 33028
        • Memorial Hospital West
      • Saint Petersburg, Florida, United States, 33705
        • Florida Cancer Specialists
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60611
        • Robert H. Lurie Comprehensive Cancer Center of Northwestern University
      • Evanston, Illinois, United States, 60201
        • NorthShore University Healthsystem
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
    • Indiana
      • Goshen, Indiana, United States, 46526
        • Goshen Center for Cancer Care
    • Iowa
      • Mason City, Iowa, United States, 50401
        • Mercy Cancer Center
    • Kentucky
      • Danville, Kentucky, United States, 40422-2534
        • Oncology-Hematology Associates, PA
      • Lexington, Kentucky, United States, 40503
        • Lexington Oncology Associates, LLC
      • Louisville, Kentucky, United States, 40245
        • Kentuckyone Health Cancer and Blood Speacialists
    • Louisiana
      • Alexandria, Louisiana, United States, 71301
        • Christus Saint Frances Cabrini Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Masonic Cancer Center
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • The University of New Mexico Cancer Research and Treatment Center
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • Jamaica, New York, United States, 11430
        • Queens Cancer Center
      • New York, New York, United States, 10021
        • Clinical Research Alliance
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals of Cleveland
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Sayre, Pennsylvania, United States, 18840
        • Guthrie Cancer Center
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Greenville Health System
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute
    • Texas
      • Dallas, Texas, United States, 752010
        • Mary Crowley Cancer Research Centers
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
    • Washington
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate
Time Frame: 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.
Up to 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of Response
Time Frame: 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.
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.
Progression Free Survival
Time Frame: 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.
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.
1-Year Survival Rate
Time Frame: 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.
From date of first study treatment to death due to any cause, assessed up to 12 months
Overall Survival
Time Frame: 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
From date of first study treatment to death due to any cause, assessed up to 24 months.
Number of Patients Experiencing Treatment-emergent Adverse Events
Time Frame: 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.
Date of first dose to 28 days after the last dose, up to an average of 5.1 months on treatment.
Blood Plasma Concentration of MGCD265 - AUC0-6
Time Frame: 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.
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 Plasma Concentration of MGCD265 - Cmax
Time Frame: 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.
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 Plasma Concentration of MGCD265 - Ctrough
Time Frame: 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.
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 Plasma Concentration of MGCD265 - Accumulation Ratio AUC0-6
Time Frame: 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.
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 Plasma Concentration of MGCD265 - Accumulation Ratio Cmax
Time Frame: 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 Ration Cmax = Cmax C1D15/ Cmax C1D1.
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 Plasma Concentration of MGCD265 - Peak to Trough Ratio
Time Frame: 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. Peak to trough ratio calculated as C1D15 Cmax/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.
Blood Plasma Concentration of MGCD265 - Tmax
Time Frame: 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. 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.
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.
Assess Correlation Between Selected Tumor Gene Alterations Using Different Analytical Techniques in Tumor Tissue and Circulating Tumor Deoxyribonucleic Acid (ctDNA) - MET Activating Mutations
Time Frame: At baseline
Only a sub-set of patients had different molecular techniques completed, therefore a correlation analysis was not performed. Patients with positive identification by two different analytical techniques are tabulated for MET Activating Mutations.
At baseline
Assess Correlation Between Selected Tumor Gene Alterations Using Different Analytical Techniques in Tumor Tissue and Circulating Tumor Deoxyribonucleic Acid (ctDNA) - MET Gene Amplifications
Time Frame: At baseline
Only a sub-set of patients had different molecular techniques completed, therefore a correlation analysis was not performed. Patients with positive identification by two different analytical techniques are tabulated for MET Gene Amplifications.
At baseline
Assess Change in Genetic Alteration Status in ctDNA With MGCD265 Treatment Over Time in the Selected Population
Time Frame: At baseline and at time of confirmation of response to treatment
At baseline and at time of confirmation of response to treatment
Blood Plasma Concentration of Soluble MET (sMET) Biomarker
Time Frame: Cycle 1 and Cycle 2
MET Activating Mutations in ctDNA. Change from Baseline - Cycle 2 Day 15 - Pre-Dose Standard Deviation not evaluable
Cycle 1 and Cycle 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mirati Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 4, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 265-109

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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