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

Primary Purpose

Non-Small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MGCD265
Sponsored by
Mirati Therapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Mirati, MGCD265, MET, NSCLC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • Clearview Cancer Institute
  • Fowler Family Center for Cancer Care
  • Providence Saint Joseph Medical Center
  • Saint Joseph Heritage Healthcare
  • University of California San Diego
  • Loma Linda University Medical Center
  • University of California, San Francisco
  • Innovative Clinical Reseach Institute
  • St. Mary's Regional Cancer Center
  • Eastern Connecticut Hematology and Oncology Associates
  • Georgetown University Medical Center
  • Boca Raton Regional Hospital - Eugene M. & Christine E. Lynn Cancer Institute
  • Sylvester Comprehensive Cancer Center
  • Florida Cancer Specialists
  • Mount Sinai Medical Center
  • Memorial Hospital West
  • Florida Cancer Specialists
  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University
  • Rush University Medical Center
  • NorthShore University HealthSystem
  • Loyola University Medical Center
  • Goshen Center for Cancer Care
  • Mercy Cancer Center
  • Oncology-Hematology Associates, PA
  • Lexington Oncology Associates, LLC
  • Kentuckyone Health Cancer and Blood Speacialists
  • Christus Saint Frances Cabrini Hospital
  • Tufts Medical Center
  • Beth Israel Deaconess Medical Center
  • Dana Farber Cancer Institute
  • Henry Ford Health System
  • University of Minnesota Masonic Cancer Center
  • Washington University
  • Hackensack University Medical Center
  • The University of New Mexico Cancer Research and Treatment Center
  • Montefiore Medical Center
  • Queens Cancer Center
  • Clinical Research Alliance
  • University Hospitals of Cleveland
  • Fox Chase Cancer Center
  • Guthrie Cancer Center
  • Greenville Health System
  • Sarah Cannon Research Institute
  • Mary Crowley Cancer Research Centers
  • MD Anderson Cancer Center
  • Seattle Cancer Care Alliance
  • Concord Repatriation General Hospital
  • Saint George Hospital
  • Royal North Shore Hospital
  • Royal Hobart Hospital
  • Monash Cancer Centre
  • Austin Health
  • Flinders Medical Centre
  • Monash Health
  • The Tweed Hospital
  • Princess Alexandra Hospital
  • McGill University Health Centre
  • Szent Borbála Kórház
  • Országos Korányi TBC és Pulmonológiai Intézet
  • Országos Onkológiai Intézet
  • Semmelweis Egyetem
  • Azienda Ospedaliero-Universitaria Careggi
  • Ospedale Unico Versilia
  • IRCCS Ospedale San Raffaele
  • Istituto Europeo di Oncologia Milano
  • Ospedale San Raffaele
  • Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto
  • Azienda Unita Sanitaria Locale di Ravenna
  • Azienda Ospedaliera Città della Salute e della Scienza di Torino
  • Chungbuk National University Hospital
  • National Cancer Center
  • Seoul National University Bundang Hospital
  • Saint Vincent Hospital
  • The Catholic University of Korea Saint Vincent's Hospital
  • Keimyung University Dongsan Medical Center
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Veterans Health Service Medical Center
  • Samsung Medical Center
  • Asan Medical Center
  • Uniwersyteckie Centrum Kliniczne
  • Samodzielny Publiczny Zespól Gruzlicy i Chorób Pluc w Olsztynie
  • Med Polonia Sp. z o.o.
  • National Cheng Kung University
  • Chi Mei Hospital Liouying
  • Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
  • Kaohsiung Medical University Hospital
  • Taichung Veterans General Hospital
  • Taipei Veterans General Hospital
  • North Bristol NHS Trust, Westbury on Trym
  • University College London Hospitals NHS Foundation Trust
  • East and North Hertordshire NHS Trust
  • Royal Free London NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm 1

Arm 2

Arm 3

Arm 4

Arm Description

MGCD265 in patients with MET activating mutations in tumor tissue

MGCD265 in patients with MET gene amplifications in tumor tissue

MGCD265 in patients with MET activating mutations in blood (circulating tumor DNA)

MGCD265 in patients with MET gene amplifications in blood (circulating tumor DNA)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
1-Year Survival Rate
1-Year Survival will be defined as the probability of survival at 1 year after the first dose.
Overall Survival
Overall Survival will be defined as the time from date of first study treatment to death due to any cause
Number of Patients Experiencing Treatment-emergent Adverse Events
Number of patients experiencing treatment-emergent adverse events.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Assess Change in Genetic Alteration Status in ctDNA With MGCD265 Treatment Over Time in the Selected Population
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

Full Information

First Posted
September 4, 2015
Last Updated
February 19, 2020
Sponsor
Mirati Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02544633
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
January 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mirati Therapeutics Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
Mirati, MGCD265, MET, NSCLC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
MGCD265 in patients with MET activating mutations in tumor tissue
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
MGCD265 in patients with MET gene amplifications in tumor tissue
Arm Title
Arm 3
Arm Type
Experimental
Arm Description
MGCD265 in patients with MET activating mutations in blood (circulating tumor DNA)
Arm Title
Arm 4
Arm Type
Experimental
Arm Description
MGCD265 in patients with MET gene amplifications in blood (circulating tumor DNA)
Intervention Type
Drug
Intervention Name(s)
MGCD265
Intervention Description
MGCD265 is a small molecule multi-targeted receptor tyrosine kinase inhibitor
Primary Outcome Measure Information:
Title
Objective Response Rate
Description
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.
Time Frame
Up to 3 months
Secondary Outcome Measure Information:
Title
Duration of Response
Description
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.
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.
Title
Progression Free Survival
Description
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.
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.
Title
1-Year Survival Rate
Description
1-Year Survival will be defined as the probability of survival at 1 year after the first dose.
Time Frame
From date of first study treatment to death due to any cause, assessed up to 12 months
Title
Overall Survival
Description
Overall Survival will be defined as the time from date of first study treatment to death due to any cause
Time Frame
From date of first study treatment to death due to any cause, assessed up to 24 months.
Title
Number of Patients Experiencing Treatment-emergent Adverse Events
Description
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.
Title
Blood Plasma Concentration of MGCD265 - AUC0-6
Description
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.
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.
Title
Blood Plasma Concentration of MGCD265 - Cmax
Description
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.
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).
Title
Blood Plasma Concentration of MGCD265 - Ctrough
Description
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.
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).
Title
Blood Plasma Concentration of MGCD265 - Accumulation Ratio AUC0-6
Description
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.
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.
Title
Blood Plasma Concentration of MGCD265 - Accumulation Ratio Cmax
Description
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.
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.
Title
Blood Plasma Concentration of MGCD265 - Peak to Trough Ratio
Description
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.
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.
Title
Blood Plasma Concentration of MGCD265 - Tmax
Description
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.
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.
Title
Assess Correlation Between Selected Tumor Gene Alterations Using Different Analytical Techniques in Tumor Tissue and Circulating Tumor Deoxyribonucleic Acid (ctDNA) - MET Activating Mutations
Description
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.
Time Frame
At baseline
Title
Assess Correlation Between Selected Tumor Gene Alterations Using Different Analytical Techniques in Tumor Tissue and Circulating Tumor Deoxyribonucleic Acid (ctDNA) - MET Gene Amplifications
Description
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.
Time Frame
At baseline
Title
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
Title
Blood Plasma Concentration of Soluble MET (sMET) Biomarker
Description
MET Activating Mutations in ctDNA. Change from Baseline - Cycle 2 Day 15 - Pre-Dose Standard Deviation not evaluable
Time Frame
Cycle 1 and Cycle 2

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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