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Non-Small Cell Lung CancerPhase 2NCT02544633

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

A Phase 2 study testing MGCD265 in people with Non-Small Cell Lung Cancer, run by Mirati Therapeutics Inc. at 94 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
MGCD265
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
94 sitesin 9 countries
Study dates
Oct 2015to Jan 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Prior treatment with inhibitor of MET or HGF
  • Prior positive test for EGFR mutation or ALK gene rearrangement
  • Uncontrolled tumor in the brain

Trial locations and contacts

94 sites in 9 countries.

94 sites in 9 countries

United States47 sites

  • The University of New Mexico Cancer Research and Treatment Center

    Albuquerque, New Mexico, 87102

  • Christus Saint Frances Cabrini Hospital

    Alexandria, Louisiana, 71301

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Boca Raton Regional Hospital - Eugene M. & Christine E. Lynn Cancer Institute

    Boca Raton, Florida, 33486

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Providence Saint Joseph Medical Center

    Burbank, California, 91505

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • Mary Crowley Cancer Research Centers

    Dallas, Texas, 752010

  • Oncology-Hematology Associates, PA

    Danville, Kentucky, 40422-2534

  • Sylvester Comprehensive Cancer Center

    Deerfield Beach, Florida, 33442-7753

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • NorthShore University HealthSystem

    Evanston, Illinois, 60201

  • Florida Cancer Specialists

    Fort Myers, Florida, 33916

  • Saint Joseph Heritage Healthcare

    Fullerton, California, 92835-3825

  • Goshen Center for Cancer Care

    Goshen, Indiana, 46526

  • St. Mary's Regional Cancer Center

    Grand Junction, Colorado, 81501

  • Greenville Health System

    Greenville, South Carolina, 29615

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Clearview Cancer Institute

    Huntsville, Alabama, 35805

  • Queens Cancer Center

    Jamaica, New York, 11430

  • Fowler Family Center for Cancer Care

    Jonesboro, Arkansas, 72401

  • University of California San Diego

    La Jolla, California, 92121

  • Lexington Oncology Associates, LLC

    Lexington, Kentucky, 40503

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Kentuckyone Health Cancer and Blood Speacialists

    Louisville, Kentucky, 40245

  • Mercy Cancer Center

    Mason City, Iowa, 50401

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • University of Minnesota Masonic Cancer Center

    Minneapolis, Minnesota, 55455

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Clinical Research Alliance

    New York, New York, 10021

  • Eastern Connecticut Hematology and Oncology Associates

    Norwich, Connecticut, 06360

  • Memorial Hospital West

    Pembroke Pines, Florida, 33028

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • University of California, San Francisco

    San Francisco, California, 94143

  • Guthrie Cancer Center

    Sayre, Pennsylvania, 18840

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Washington University

    St Louis, Missouri, 63110

  • Florida Cancer Specialists

    St. Petersburg, Florida, 33705

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Innovative Clinical Reseach Institute

    Whittier, California, 90603

Other trials in United States

South Korea11 sites

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, 361-271

  • Keimyung University Dongsan Medical Center

    Daegu, 700-712

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 410-769

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 463-707

  • Seoul National University Hospital

    Seoul, 110-744

  • Severance Hospital, Yonsei University Health System

    Seoul, 120-752

  • Veterans Health Service Medical Center

    Seoul, 134-791

  • Samsung Medical Center

    Seoul, 135-710

  • Asan Medical Center

    Seoul, 138-736

  • Saint Vincent Hospital

    Suwon, Gyeonggi-do, 442-723

  • The Catholic University of Korea Saint Vincent's Hospital

    Suwon, Gyeonggi-do, 442-723

Other trials in South Korea

Australia10 sites

  • Flinders Medical Centre

    Bedford Park, 5042

  • Monash Cancer Centre

    Clayton, Victoria, 3165

  • Monash Health

    Clayton, 3165

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • Austin Health

    Heidelberg, Victoria, 3084

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • Saint George Hospital

    Kogarah, New South Wales, 2217

  • Royal North Shore Hospital

    Saint Leonards, New South Wales, 2065

  • The Tweed Hospital

    Tweed Heads, 2485

  • Princess Alexandra Hospital

    Woolloongabba, 4102

Other trials in Australia

Italy8 sites

  • Azienda Ospedaliero-Universitaria Careggi

    Florence, 50139

  • Ospedale Unico Versilia

    Lucca, 55041

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • Istituto Europeo di Oncologia Milano

    Milan, 20132

  • Ospedale San Raffaele

    Milan, 20132

  • Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto

    Piacenza, 29100

  • Azienda Unita Sanitaria Locale di Ravenna

    Ravenna, 48121

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Torino, 10126

Other trials in Italy

Taiwan6 sites

  • Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

    Hualien City, 970

  • Kaohsiung Medical University Hospital

    Kaohsiung City, 807

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Cheng Kung University

    Tainan, Tainan CITY, 70403

  • Chi Mei Hospital Liouying

    Tainan, Tainan, 73657

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

Hungary4 sites

  • Országos Korányi TBC és Pulmonológiai Intézet

    Budapest, 1121

  • Országos Onkológiai Intézet

    Budapest, 1122

  • Semmelweis Egyetem

    Budapest, 1125

  • Szent Borbála Kórház

    Tatabánya, Komárom-Esztergom, 2800

Other trials in Hungary

United Kingdom4 sites

  • North Bristol NHS Trust, Westbury on Trym

    Bristol, England, BS10 5NB

  • University College London Hospitals NHS Foundation Trust

    London, England, NW1 2PQ

  • Royal Free London NHS Foundation Trust

    London, NW3 2QG

  • East and North Hertordshire NHS Trust

    Northwood, England, HA6 2RN

Other trials in United Kingdom

Poland3 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, Pomeranian Voivodeship, 80-952

  • Samodzielny Publiczny Zespól Gruzlicy i Chorób Pluc w Olsztynie

    Olsztyn, Warmian-Masurian Voivodeship, 10-357

  • Med Polonia Sp. z o.o.

    Poznan, Greater Poland Voivodeship, 60-693

Other trials in Poland

Canada1 site

  • McGill University Health Centre

    Montreal, H2W 1S6

Other trials in Canada

About this study

Official title: 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.

Read the detailed description

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

Being tested
MGCD265
Keywords
Mirati, MGCD265, MET, NSCLC
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MGCD265Drug

    MGCD265 is a small molecule multi-targeted receptor tyrosine kinase inhibitor

Study groups in NCT02544633
Study groupRoleWhat they receive
Arm 1ExperimentalMGCD265 in patients with MET activating mutations in tumor tissue
Receives: Drug: MGCD265
Arm 2ExperimentalMGCD265 in patients with MET gene amplifications in tumor tissue
Receives: Drug: MGCD265
Arm 3ExperimentalMGCD265 in patients with MET activating mutations in blood (circulating tumor DNA)
Receives: Drug: MGCD265
Arm 4ExperimentalMGCD265 in patients with MET gene amplifications in blood (circulating tumor DNA)
Receives: Drug: MGCD265

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 3 months

Secondary outcomes (16)

  1. Duration of Response

    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.

    Measured: 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.

  2. Progression Free Survival

    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.

    Measured: 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.

  3. 1-Year Survival Rate

    1-Year Survival will be defined as the probability of survival at 1 year after the first dose.

    Measured: From date of first study treatment to death due to any cause, assessed up to 12 months

  4. Overall Survival

    Overall Survival will be defined as the time from date of first study treatment to death due to any cause

    Measured: From date of first study treatment to death due to any cause, assessed up to 24 months.

  5. Number of Patients Experiencing Treatment-emergent Adverse Events

    Number of patients experiencing treatment-emergent adverse events.

    Measured: Date of first dose to 28 days after the last dose, up to an average of 5.1 months on treatment.

  6. Blood Plasma Concentration of MGCD265 - AUC0-6

    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.

    Measured: 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.

  7. Blood Plasma Concentration of MGCD265 - Cmax

    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.

    Measured: 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).

  8. Blood Plasma Concentration of MGCD265 - Ctrough

    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.

    Measured: 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).

  9. Blood Plasma Concentration of MGCD265 - Accumulation Ratio AUC0-6

    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.

    Measured: 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.

  10. Blood Plasma Concentration of MGCD265 - Accumulation Ratio Cmax

    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.

    Measured: 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.

  11. Blood Plasma Concentration of MGCD265 - Peak to Trough Ratio

    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.

    Measured: 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.

  12. Blood Plasma Concentration of MGCD265 - Tmax

    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.

    Measured: 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.

  13. Assess Correlation Between Selected Tumor Gene Alterations Using Different Analytical Techniques in Tumor Tissue and Circulating Tumor Deoxyribonucleic Acid (ctDNA) - MET Activating Mutations

    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.

    Measured: At baseline

  14. Assess Correlation Between Selected Tumor Gene Alterations Using Different Analytical Techniques in Tumor Tissue and Circulating Tumor Deoxyribonucleic Acid (ctDNA) - MET Gene Amplifications

    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.

    Measured: At baseline

  15. Assess Change in Genetic Alteration Status in ctDNA With MGCD265 Treatment Over Time in the Selected Population

    Measured: At baseline and at time of confirmation of response to treatment

  16. Blood Plasma Concentration of Soluble MET (sMET) Biomarker

    MET Activating Mutations in ctDNA. Change from Baseline - Cycle 2 Day 15 - Pre-Dose Standard Deviation not evaluable

    Measured: Cycle 1 and Cycle 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2015 (estimated)
  2. Study startOct 2015
  3. Primary completion30 Apr 2018
  4. Study completionJan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02544633
Sponsor's protocol ID
265-109
Status last verified
Feb 2020
First submitted
4 Sep 2015
Last updated
4 Mar 2020
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 38417277

  • Kollmannsberger 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.

    PubMed 36459255

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MGCD265 in people with Non-Small Cell Lung Cancer, run by Mirati Therapeutics Inc. at 94 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 sites in United States, South Korea, Australia, Italy, Taiwan and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02544633, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.

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