Clinical trial NCT02544633: Phase 2 Study of MGCD265 in Patients With Non-Small Cell Lung Cancer With Activating Genetic Alterations in MET
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Keywords: Mirati
MGCD265
MET
NSCLC
Lead sponsor: Mirati Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2015-09-09
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Objective Response Rate
timeFrame: Up to 3 months
Secondary outcomes:
measure: Duration of Response
timeFrame: 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.
measure: Progression Free Survival
timeFrame: 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.
measure: 1-Year Survival Rate
timeFrame: From date of first study treatment to death due to any cause, assessed up to 12 months
measure: Overall Survival
timeFrame: From date of first study treatment to death due to any cause, assessed up to 24 months.
measure: Number of Patients Experiencing Treatment-emergent Adverse Events
timeFrame: Date of first dose to 28 days after the last dose, up to an average of 5.1 months on treatment.
measure: Blood Plasma Concentration of MGCD265 - AUC0-6
timeFrame: 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.
measure: Blood Plasma Concentration of MGCD265 - Cmax
timeFrame: 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).
measure: Blood Plasma Concentration of MGCD265 - Ctrough
timeFrame: 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).
measure: Blood Plasma Concentration of MGCD265 - Accumulation Ratio AUC0-6
timeFrame: 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.
measure: Blood Plasma Concentration of MGCD265 - Accumulation Ratio Cmax
timeFrame: 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.
measure: Blood Plasma Concentration of MGCD265 - Peak to Trough Ratio
timeFrame: 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.
measure: Blood Plasma Concentration of MGCD265 - Tmax
timeFrame: 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.
measure: Assess Correlation Between Selected Tumor Gene Alterations Using Different Analytical Techniques in Tumor Tissue and Circulating Tumor Deoxyribonucleic Acid (ctDNA) - MET Activating Mutations
timeFrame: At baseline
measure: Assess Correlation Between Selected Tumor Gene Alterations Using Different Analytical Techniques in Tumor Tissue and Circulating Tumor Deoxyribonucleic Acid (ctDNA) - MET Gene Amplifications
timeFrame: At baseline
measure: Assess Change in Genetic Alteration Status in ctDNA With MGCD265 Treatment Over Time in the Selected Population
timeFrame: At baseline and at time of confirmation of response to treatment
measure: Blood Plasma Concentration of Soluble MET (sMET) Biomarker
timeFrame: Cycle 1 and Cycle 2
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Huntsville
country: United States
facility: Clearview Cancer Institute
state: Alabama
city: Jonesboro
country: United States
facility: Fowler Family Center for Cancer Care
state: Arkansas
city: Burbank
country: United States
facility: Providence Saint Joseph Medical Center
state: California
city: Fullerton
country: United States
facility: Saint Joseph Heritage Healthcare
state: California
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Whittier
country: United States
facility: Innovative Clinical Reseach Institute
state: California
city: Grand Junction
country: United States
facility: St. Mary's Regional Cancer Center
state: Colorado
city: Norwich
country: United States
facility: Eastern Connecticut Hematology and Oncology Associates
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Boca Raton
country: United States
facility: Boca Raton Regional Hospital - Eugene M. & Christine E. Lynn Cancer Institute
state: Florida
city: Deerfield Beach
country: United States
facility: Sylvester Comprehensive Cancer Center
state: Florida
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Pembroke Pines
country: United States
facility: Memorial Hospital West
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center of Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Goshen
country: United States
facility: Goshen Center for Cancer Care
state: Indiana
city: Mason City
country: United States
facility: Mercy Cancer Center
state: Iowa
city: Danville
country: United States
facility: Oncology-Hematology Associates, PA
state: Kentucky
city: Lexington
country: United States
facility: Lexington Oncology Associates, LLC
state: Kentucky
city: Louisville
country: United States
facility: Kentuckyone Health Cancer and Blood Speacialists
state: Kentucky
city: Alexandria
country: United States
facility: Christus Saint Frances Cabrini Hospital
state: Louisiana
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Masonic Cancer Center
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: The University of New Mexico Cancer Research and Treatment Center
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Jamaica
country: United States
facility: Queens Cancer Center
state: New York
city: New York
country: United States
facility: Clinical Research Alliance
state: New York
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Sayre
country: United States
facility: Guthrie Cancer Center
state: Pennsylvania
city: Greenville
country: United States
facility: Greenville Health System
state: South Carolina
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Dallas
country: United States
facility: Mary Crowley Cancer Research Centers
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Kogarah
country: Australia
facility: Saint George Hospital
state: New South Wales
city: Saint Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Clayton
country: Australia
facility: Monash Cancer Centre
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
city: Clayton
country: Australia
facility: Monash Health
city: Tweed Heads
country: Australia
facility: The Tweed Hospital
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
city: Montréal
country: Canada
facility: McGill University Health Centre
city: Tatabánya
country: Hungary
facility: Szent Borbála Kórház
state: Komarom-esztergom
city: Budapest
country: Hungary
facility: Országos Korányi TBC és Pulmonológiai Intézet
city: Budapest
country: Hungary
facility: Országos Onkológiai Intézet
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi
city: Lucca
country: Italy
facility: Ospedale Unico Versilia
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia Milano
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Piacenza
country: Italy
facility: Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto
city: Ravenna
country: Italy
facility: Azienda Unita Sanitaria Locale di Ravenna
city: Torino
country: Italy
facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: Chungcheongbuk-do
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: Saint Vincent Hospital
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University of Korea Saint Vincent's Hospital
state: Gyeonggi-do
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Veterans Health Service Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Gdańsk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
state: Pomorskie
city: Olsztyn
country: Poland
facility: Samodzielny Publiczny Zespól Gruzlicy i Chorób Pluc w Olsztynie
state: Warminsko-mazurskie
city: Poznan
country: Poland
facility: Med Polonia Sp. z o.o.
state: Wielkopolskie
city: Tainan
country: Taiwan
facility: National Cheng Kung University
state: Tainan CITY
city: Tainan City
country: Taiwan
facility: Chi Mei Hospital Liouying
state: Tainan
city: Hualien City
country: Taiwan
facility: Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Bristol
country: United Kingdom
facility: North Bristol NHS Trust, Westbury on Trym
state: England
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust
state: England
city: Northwood
country: United Kingdom
facility: East and North Hertordshire NHS Trust
state: England
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust
Study officials:
References: