Phase 2 Study of MGCD265 in Patients With Non-Small Cell Lung Cancer With Activating Genetic Alterations in MET
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
1 other identifier
interventional
68
9 countries
94
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 nonsmall-cell-lung-cancer
Started Oct 2015
94 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2015
CompletedFirst Posted
Study publicly available on registry
September 9, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedResults Posted
Study results publicly available
September 10, 2019
CompletedMarch 4, 2020
February 1, 2020
2.6 years
September 4, 2015
April 30, 2019
February 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate
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 Outcomes (16)
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.
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.
1-Year Survival Rate
From date of first study treatment to death due to any cause, assessed up to 12 months
Overall Survival
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
Date of first dose to 28 days after the last dose, up to an average of 5.1 months on treatment.
- +11 more secondary outcomes
Study Arms (4)
Arm 1
EXPERIMENTALMGCD265 in patients with MET activating mutations in tumor tissue
Arm 2
EXPERIMENTALMGCD265 in patients with MET gene amplifications in tumor tissue
Arm 3
EXPERIMENTALMGCD265 in patients with MET activating mutations in blood (circulating tumor DNA)
Arm 4
EXPERIMENTALMGCD265 in patients with MET gene amplifications in blood (circulating tumor DNA)
Interventions
MGCD265 is a small molecule multi-targeted receptor tyrosine kinase inhibitor
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Prior treatment with inhibitor of MET or HGF
- Prior positive test for EGFR mutation or ALK gene rearrangement
- Uncontrolled tumor in the brain
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (94)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Clearview Cancer Institute
Huntsville, Alabama, 35805, United States
Fowler Family Center for Cancer Care
Jonesboro, Arkansas, 72401, United States
Providence Saint Joseph Medical Center
Burbank, California, 91505, United States
Saint Joseph Heritage Healthcare
Fullerton, California, 92835-3825, United States
University of California San Diego
La Jolla, California, 92121, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
University of California, San Francisco
San Francisco, California, 94143, United States
Innovative Clinical Reseach Institute
Whittier, California, 90603, United States
St. Mary's Regional Cancer Center
Grand Junction, Colorado, 81501, United States
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, 06360, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
Boca Raton Regional Hospital - Eugene M. & Christine E. Lynn Cancer Institute
Boca Raton, Florida, 33486, United States
Sylvester Comprehensive Cancer Center
Deerfield Beach, Florida, 33442-7753, United States
Florida Cancer Specialists
Fort Myers, Florida, 33916, United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
Memorial Hospital West
Pembroke Pines, Florida, 33028, United States
Florida Cancer Specialists
St. Petersburg, Florida, 33705, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
NorthShore University HealthSystem
Evanston, Illinois, 60201, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Goshen Center for Cancer Care
Goshen, Indiana, 46526, United States
Mercy Cancer Center
Mason City, Iowa, 50401, United States
Oncology-Hematology Associates, PA
Danville, Kentucky, 40422-2534, United States
Lexington Oncology Associates, LLC
Lexington, Kentucky, 40503, United States
Kentuckyone Health Cancer and Blood Speacialists
Louisville, Kentucky, 40245, United States
Christus Saint Frances Cabrini Hospital
Alexandria, Louisiana, 71301, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
Washington University
St Louis, Missouri, 63110, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
The University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, 87102, United States
Queens Cancer Center
Jamaica, New York, 11430, United States
Clinical Research Alliance
New York, New York, 10021, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Guthrie Cancer Center
Sayre, Pennsylvania, 18840, United States
Greenville Health System
Greenville, South Carolina, 29615, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Mary Crowley Cancer Research Centers
Dallas, Texas, 752010, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
Saint George Hospital
Kogarah, New South Wales, 2217, Australia
Royal North Shore Hospital
Saint Leonards, New South Wales, 2065, Australia
Royal Hobart Hospital
Hobart, Tasmania, 7000, Australia
Monash Cancer Centre
Clayton, Victoria, 3165, Australia
Austin Health
Heidelberg, Victoria, 3084, Australia
Flinders Medical Centre
Bedford Park, 5042, Australia
Monash Health
Clayton, 3165, Australia
The Tweed Hospital
Tweed Heads, 2485, Australia
Princess Alexandra Hospital
Woolloongabba, 4102, Australia
McGill University Health Centre
Montreal, H2W 1S6, Canada
Szent Borbála Kórház
Tatabánya, Komárom-Esztergom, 2800, Hungary
Országos Korányi TBC és Pulmonológiai Intézet
Budapest, 1121, Hungary
Országos Onkológiai Intézet
Budapest, 1122, Hungary
Semmelweis Egyetem
Budapest, 1125, Hungary
Azienda Ospedaliero-Universitaria Careggi
Florence, 50139, Italy
Ospedale Unico Versilia
Lucca, 55041, Italy
IRCCS Ospedale San Raffaele
Milan, 20132, Italy
Istituto Europeo di Oncologia Milano
Milan, 20132, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto
Piacenza, 29100, Italy
Azienda Unita Sanitaria Locale di Ravenna
Ravenna, 48121, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, 10126, Italy
Med Polonia Sp. z o.o.
Poznan, Greater Poland Voivodeship, 60-693, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, 80-952, Poland
Samodzielny Publiczny Zespól Gruzlicy i Chorób Pluc w Olsztynie
Olsztyn, Warmian-Masurian Voivodeship, 10-357, Poland
National Cancer Center
Goyang-si, Gyeonggi-do, 410-769, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707, South Korea
Saint Vincent Hospital
Suwon, Gyeonggi-do, 442-723, South Korea
The Catholic University of Korea Saint Vincent's Hospital
Suwon, Gyeonggi-do, 442-723, South Korea
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, 361-271, South Korea
Keimyung University Dongsan Medical Center
Daegu, 700-712, South Korea
Seoul National University Hospital
Seoul, 110-744, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 120-752, South Korea
Veterans Health Service Medical Center
Seoul, 134-791, South Korea
Samsung Medical Center
Seoul, 135-710, South Korea
Asan Medical Center
Seoul, 138-736, South Korea
National Cheng Kung University
Tainan, Tainan CITY, 70403, Taiwan
Chi Mei Hospital Liouying
Tainan, Tainan, 73657, Taiwan
Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Hualien City, 970, Taiwan
Kaohsiung Medical University Hospital
Kaohsiung City, 807, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
North Bristol NHS Trust, Westbury on Trym
Bristol, England, BS10 5NB, United Kingdom
University College London Hospitals NHS Foundation Trust
London, England, NW1 2PQ, United Kingdom
East and North Hertordshire NHS Trust
Northwood, England, HA6 2RN, United Kingdom
Royal Free London NHS Foundation Trust
London, NW3 2QG, United Kingdom
Related Publications (2)
Hong DS, Cappuzzo F, Chul Cho B, Dowlati A, Hussein M, Kim DW, Percent I, Christensen JG, Morin J, Potvin D, Faltaos D, Tassell V, Der-Torossian H, Chao R. Phase II study investigating the efficacy and safety of glesatinib (MGCD265) in patients with advanced NSCLC containing MET activating alterations. Lung Cancer. 2024 Apr;190:107512. doi: 10.1016/j.lungcan.2024.107512. Epub 2024 Feb 22.
PMID: 38417277DERIVEDKollmannsberger C, Hurwitz H, Bazhenova L, Cho BC, Hong D, Park K, Reckamp KL, Sharma S, Der-Torossian H, Christensen JG, Faltaos D, Potvin D, Tassell V, Chao R, Shapiro GI. Phase I Study Evaluating Glesatinib (MGCD265), An Inhibitor of MET and AXL, in Patients with Non-small Cell Lung Cancer and Other Advanced Solid Tumors. Target Oncol. 2023 Jan;18(1):105-118. doi: 10.1007/s11523-022-00931-9. Epub 2022 Dec 2.
PMID: 36459255DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Early closure of the study is due to sponsor portfolio prioritization and not due to any patient safety issues.
Results Point of Contact
- Title
- Vanessa Tassell, Vice President, Clinical Science
- Organization
- Mirati Therapeutics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2015
First Posted
September 9, 2015
Study Start
October 1, 2015
Primary Completion
April 30, 2018
Study Completion
January 1, 2019
Last Updated
March 4, 2020
Results First Posted
September 10, 2019
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share