Non-Small Cell Lung Cancer Clinical Trial
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
NCT number | NCT02544633 |
Other study ID # | 265-109 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | October 2015 |
Est. completion date | January 2019 |
Verified date | February 2020 |
Source | Mirati Therapeutics Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 68 |
Est. completion date | January 2019 |
Est. primary completion date | April 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Australia | Flinders Medical Centre | Bedford Park | |
Australia | Monash Cancer Centre | Clayton | Victoria |
Australia | Monash Health | Clayton | |
Australia | Concord Repatriation General Hospital | Concord | New South Wales |
Australia | Austin Health | Heidelberg | Victoria |
Australia | Royal Hobart Hospital | Hobart | Tasmania |
Australia | Saint George Hospital | Kogarah | New South Wales |
Australia | Royal North Shore Hospital | Saint Leonards | New South Wales |
Australia | The Tweed Hospital | Tweed Heads | |
Australia | Princess Alexandra Hospital | Woolloongabba | |
Canada | McGill University Health Centre | Montréal | |
Hungary | Országos Korányi TBC és Pulmonológiai Intézet | Budapest | |
Hungary | Országos Onkológiai Intézet | Budapest | |
Hungary | Semmelweis Egyetem | Budapest | |
Hungary | Szent Borbála Kórház | Tatabánya | Komarom-esztergom |
Italy | Azienda Ospedaliero-Universitaria Careggi | Firenze | |
Italy | Ospedale Unico Versilia | Lucca | |
Italy | IRCCS Ospedale San Raffaele | Milano | |
Italy | Istituto Europeo di Oncologia Milano | Milano | |
Italy | Ospedale San Raffaele | Milano | |
Italy | Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto | Piacenza | |
Italy | Azienda Unita Sanitaria Locale di Ravenna | Ravenna | |
Italy | Azienda Ospedaliera Città della Salute e della Scienza di Torino | Torino | |
Korea, Republic of | Chungbuk National University Hospital | Cheongju | Chungcheongbuk-do |
Korea, Republic of | Keimyung University Dongsan Medical Center | Daegu | |
Korea, Republic of | National Cancer Center | Goyang | Gyeonggi-do |
Korea, Republic of | Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do |
Korea, Republic of | Asan Medical Center | Seoul | |
Korea, Republic of | Samsung Medical Center | Seoul | |
Korea, Republic of | Seoul National University Hospital | Seoul | |
Korea, Republic of | Severance Hospital, Yonsei University Health System | Seoul | |
Korea, Republic of | Veterans Health Service Medical Center | Seoul | |
Korea, Republic of | Saint Vincent Hospital | Suwon-si | Gyeonggi-do |
Korea, Republic of | The Catholic University of Korea Saint Vincent's Hospital | Suwon-si | Gyeonggi-do |
Poland | Uniwersyteckie Centrum Kliniczne | Gdansk | Pomorskie |
Poland | Samodzielny Publiczny Zespól Gruzlicy i Chorób Pluc w Olsztynie | Olsztyn | Warminsko-mazurskie |
Poland | Med Polonia Sp. z o.o. | Poznan | Wielkopolskie |
Taiwan | Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation | Hualien City | |
Taiwan | Kaohsiung Medical University Hospital | Kaohsiung | |
Taiwan | Taichung Veterans General Hospital | Taichung | |
Taiwan | National Cheng Kung University | Tainan | Tainan CITY |
Taiwan | Chi Mei Hospital Liouying | Tainan City | Tainan |
Taiwan | Taipei Veterans General Hospital | Taipei | |
United Kingdom | North Bristol NHS Trust, Westbury on Trym | Bristol | England |
United Kingdom | Royal Free London NHS Foundation Trust | London | |
United Kingdom | University College London Hospitals NHS Foundation Trust | London | England |
United Kingdom | East and North Hertordshire NHS Trust | Northwood | England |
United States | The University of New Mexico Cancer Research and Treatment Center | Albuquerque | New Mexico |
United States | Christus Saint Frances Cabrini Hospital | Alexandria | Louisiana |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Boca Raton Regional Hospital - Eugene M. & Christine E. Lynn Cancer Institute | Boca Raton | Florida |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
United States | Tufts Medical Center | Boston | Massachusetts |
United States | Montefiore Medical Center | Bronx | New York |
United States | Providence Saint Joseph Medical Center | Burbank | California |
United States | Robert H. Lurie Comprehensive Cancer Center of Northwestern University | Chicago | Illinois |
United States | Rush University Medical Center | Chicago | Illinois |
United States | University Hospitals of Cleveland | Cleveland | Ohio |
United States | Mary Crowley Cancer Research Centers | Dallas | Texas |
United States | Oncology-Hematology Associates, PA | Danville | Kentucky |
United States | Sylvester Comprehensive Cancer Center | Deerfield Beach | Florida |
United States | Henry Ford Health System | Detroit | Michigan |
United States | NorthShore University HealthSystem | Evanston | Illinois |
United States | Florida Cancer Specialists | Fort Myers | Florida |
United States | Saint Joseph Heritage Healthcare | Fullerton | California |
United States | Goshen Center for Cancer Care | Goshen | Indiana |
United States | St. Mary's Regional Cancer Center | Grand Junction | Colorado |
United States | Greenville Health System | Greenville | South Carolina |
United States | Hackensack University Medical Center | Hackensack | New Jersey |
United States | MD Anderson Cancer Center | Houston | Texas |
United States | Clearview Cancer Institute | Huntsville | Alabama |
United States | Queens Cancer Center | Jamaica | New York |
United States | Fowler Family Center for Cancer Care | Jonesboro | Arkansas |
United States | University of California San Diego | La Jolla | California |
United States | Lexington Oncology Associates, LLC | Lexington | Kentucky |
United States | Loma Linda University Medical Center | Loma Linda | California |
United States | Kentuckyone Health Cancer and Blood Speacialists | Louisville | Kentucky |
United States | Mercy Cancer Center | Mason City | Iowa |
United States | Loyola University Medical Center | Maywood | Illinois |
United States | Mount Sinai Medical Center | Miami Beach | Florida |
United States | University of Minnesota Masonic Cancer Center | Minneapolis | Minnesota |
United States | Sarah Cannon Research Institute | Nashville | Tennessee |
United States | Clinical Research Alliance | New York | New York |
United States | Eastern Connecticut Hematology and Oncology Associates | Norwich | Connecticut |
United States | Memorial Hospital West | Pembroke Pines | Florida |
United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
United States | Washington University | Saint Louis | Missouri |
United States | Florida Cancer Specialists | Saint Petersburg | Florida |
United States | University of California, San Francisco | San Francisco | California |
United States | Guthrie Cancer Center | Sayre | Pennsylvania |
United States | Seattle Cancer Care Alliance | Seattle | Washington |
United States | Georgetown University Medical Center | Washington | District of Columbia |
United States | Innovative Clinical Reseach Institute | Whittier | California |
Lead Sponsor | Collaborator |
---|---|
Mirati Therapeutics Inc. |
United States, Australia, Canada, Hungary, Italy, Korea, Republic of, Poland, Taiwan, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | 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. | |
Secondary | 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. | 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. | |
Secondary | 1-Year Survival Rate | 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 | |
Secondary | Overall Survival | 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. | |
Secondary | Number of Patients Experiencing Treatment-emergent Adverse Events | 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. | |
Secondary | 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. | 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. | |
Secondary | 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. | 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). | |
Secondary | 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. | 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). | |
Secondary | 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. | 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. | |
Secondary | 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. | 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. | |
Secondary | 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. | 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. | |
Secondary | 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. | 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. | |
Secondary | 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. | At baseline | |
Secondary | 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. | At baseline | |
Secondary | Assess Change in Genetic Alteration Status in ctDNA With MGCD265 Treatment Over Time in the Selected Population | At baseline and at time of confirmation of response to treatment | ||
Secondary | 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 | Cycle 1 and Cycle 2 |
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