Phase 2 Study of MGCD265 in Patients With Non-Small Cell... | NCT02544633 | Trialant
NCT02544633
Sponsor
Mirati Therapeutics Inc.
Status
Completed
Last Update Posted
Mar 4, 2020Actual
Enrollment
68Actual
Phase
Phase 2
Conditions
Non-Small Cell Lung Cancer
Interventions
MGCD265
Countries
United States
Australia
Canada
Hungary
Italy
Poland
South Korea
Taiwan
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02544633
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
265-109
Secondary IDs
Not provided
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
Acronym
Not provided
Organization
Mirati Therapeutics Inc.INDUSTRY
Status Module
Record Verification Date
Feb 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 2015
Primary Completion Date
Apr 30, 2018Actual
Completion Date
Jan 2019Actual
First Submitted Date
Sep 4, 2015
First Submission Date that Met QC Criteria
Sep 4, 2015
First Posted Date
Sep 9, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 30, 2019
Results First Submitted that Met QC Criteria
Sep 6, 2019
Results First Posted Date
Sep 10, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 19, 2020
Last Update Posted Date
Mar 4, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Mirati Therapeutics Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Conditions Module
Conditions
Non-Small Cell Lung Cancer
Keywords
Mirati
MGCD265
MET
NSCLC
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
68Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm 1
Experimental
MGCD265 in patients with MET activating mutations in tumor tissue
Drug: MGCD265
Arm 2
Experimental
MGCD265 in patients with MET gene amplifications in tumor tissue
Drug: MGCD265
Arm 3
Experimental
MGCD265 in patients with MET activating mutations in blood (circulating tumor DNA)
Drug: MGCD265
Arm 4
Experimental
MGCD265 in patients with MET gene amplifications in blood (circulating tumor DNA)
Drug: MGCD265
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MGCD265
Drug
MGCD265 is a small molecule multi-targeted receptor tyrosine kinase inhibitor
Arm 1
Arm 2
Arm 3
Arm 4
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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
Measure
Description
Time Frame
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.
Other Outcomes
Not provided
Eligibility Module
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
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.
Sponsor approval of each potential patient's genetic testing following prescreening, whether performed by the study central lab or a Sponsor-approved local lab, was filed prior to proceeding to full clinical screening. All patients considered eligible for the study following clinical screening were submitted to Sponsor for registration approval.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
MET Activating Mutations in Tumor Tissue
MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.
FG001
MET Gene Amplifications in Tumor Tissue
Periods
Title
Milestones
Reasons Not Completed
Treatment Period
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Mar 23, 2017
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
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.
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
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.
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.
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.
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).
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).
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.
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.
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.
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.
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
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
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
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
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
Derived
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.
MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.
FG002
MET Activating Mutations in ctDNA
MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).
FG003
MET Gene Amplifications in ctDNA
MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).
FG00028 subjects
FG00120 subjects
FG0028 subjects
FG00312 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
NOT COMPLETED
FG00028 subjects
FG00120 subjects
FG0028 subjects
FG00312 subjects
Type
Comment
Reasons
Patient Still on Treatment/Study
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
Adverse Event
FG0007 subjects
FG0014 subjects
FG0020 subjects
FG0035 subjects
Lack of Efficacy
FG00017 subjects
FG00111 subjects
FG0025 subjects
FG0035 subjects
Global Deterioration of Health
FG0003 subjects
FG0013 subjects
FG0020 subjects
FG0031 subjects
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Death
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Non-compliance
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Clinical Disease Progression
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
Survival Follow-up Period
Type
Comment
Milestone Data
STARTED
2 patients on treatment at the time of primary report date
FG00028 subjects
FG00119 subjects
FG0027 subjects
FG00312 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
NOT COMPLETED
FG00028 subjects
FG00119 subjects
FG0027 subjects
FG00312 subjects
Type
Comment
Reasons
Death
FG00012 subjects
FG00114 subjects
FG0023 subjects
FG003
These figures are based on the safety population.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
MET Activating Mutations in Tumor Tissue
MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.
BG001
MET Gene Amplifications in Tumor Tissue
MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.
BG002
MET Activating Mutations in ctDNA
MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).
BG003
MET Gene Amplifications in ctDNA
MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00028
BG00120
BG0028
BG00312
BG00468
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Mean
Standard Deviation
years
Title
Denominators
Categories
Mean (STD)
ParticipantsBG00028
ParticipantsBG00120
ParticipantsBG0028
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00028
ParticipantsBG00120
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00028
ParticipantsBG00120
ParticipantsBG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00028
ParticipantsBG00120
ParticipantsBG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
White
ParticipantsBG00028
ParticipantsBG00120
ParticipantsBG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
South Korea
ParticipantsBG00028
ParticipantsBG00120
ParticipantsBG002
Height
Some patients did not have height recorded at baseline
Mean
Standard Deviation
cm
Title
Denominators
Categories
ParticipantsBG00026
ParticipantsBG00120
ParticipantsBG002
Body Mass Index
BMI unable to be calculated in patients with no height recorded at baseline
Mean
Standard Deviation
kg/m^2
Title
Denominators
Categories
ParticipantsBG00026
ParticipantsBG00120
ParticipantsBG002
Weight
Mean
Standard Deviation
kg
Title
Denominators
Categories
ParticipantsBG00028
ParticipantsBG00120
ParticipantsBG002
ECOG Performance Status
0: Fully active, able to carry on all pre-disease performance without restriction
Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours
Capable of only limited self care, confined to bed or chair more than 50% of waking hours
Completely disabled. Cannot carry on any self care. Totally confined to bed or chair
Dead
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00028
ParticipantsBG001
Primary Disease Histology
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00028
ParticipantsBG00120
ParticipantsBG002
Current Stage
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00028
ParticipantsBG00120
ParticipantsBG002
Smoking History
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00028
ParticipantsBG00120
ParticipantsBG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
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.
Modified Intent-to-Treat (mITT) Population defined as all patients who received at least one dose of MGCD265
Posted
Number
95% Confidence Interval
percentage of participants
Up to 3 months
ID
Title
Description
OG000
MET Activating Mutations in Tumor Tissue
MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.
OG001
MET Gene Amplifications in Tumor Tissue
MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.
OG002
MET Activating Mutations in ctDNA
MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).
OG003
MET Gene Amplifications in ctDNA
MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).
Units
Counts
Participants
OG00028
OG00120
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG00010.7(2.27 to 28.23)
OG00115.0(3.21 to 37.89)
OG00225.0(3.19 to 65.09)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
exact test
0.94
Objective response rate
10.7
2-Sided
95
2.27
28.23
Superiority
An exact test for single proportion (two-sided a=5%) will be performed to test H0: ORR <=20% against H1: ORR >20%.
OG001
exact test
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.
Modified Intent-to-Treat (mITT) Population defined as all patients who received at least one dose of MGCD265
Posted
Median
95% Confidence Interval
days
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.
ID
Title
Description
OG000
MET Activating Mutations in Tumor Tissue
MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.
OG001
MET Gene Amplifications in Tumor Tissue
MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.
OG002
MET Activating Mutations in ctDNA
MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).
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.
Modified Intent-to-Treat (mITT) Population defined as all patients who received at least one dose of MGCD265
Posted
Median
95% Confidence Interval
months
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.
ID
Title
Description
OG000
MET Activating Mutations in Tumor Tissue
MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.
OG001
MET Gene Amplifications in Tumor Tissue
MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.
OG002
MET Activating Mutations in ctDNA
Secondary
1-Year Survival Rate
1-Year Survival will be defined as the probability of survival at 1 year after the first dose.
Modified Intent-to-Treat (mITT) Population defined as all patients who received at least one dose of MGCD265
Posted
Number
95% Confidence Interval
percentage
From date of first study treatment to death due to any cause, assessed up to 12 months
ID
Title
Description
OG000
MET Activating Mutations in Tumor Tissue
MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.
OG001
MET Gene Amplifications in Tumor Tissue
MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.
OG002
MET Activating Mutations in ctDNA
MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).
OG003
MET Gene Amplifications in ctDNA
Secondary
Overall Survival
Overall Survival will be defined as the time from date of first study treatment to death due to any cause
Modified Intent-to-Treat (mITT) Population defined as all patients who received at least one dose of MGCD265
Posted
Median
95% Confidence Interval
months
From date of first study treatment to death due to any cause, assessed up to 24 months.
ID
Title
Description
OG000
MET Activating Mutations in Tumor Tissue
MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.
OG001
MET Gene Amplifications in Tumor Tissue
MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.
OG002
MET Activating Mutations in ctDNA
MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).
OG003
MET Gene Amplifications in ctDNA
Secondary
Number of Patients Experiencing Treatment-emergent Adverse Events
Number of patients experiencing treatment-emergent adverse events.
Safety population
Posted
Count of Participants
Participants
Date of first dose to 28 days after the last dose, up to an average of 5.1 months on treatment.
ID
Title
Description
OG000
MET Activating Mutations in Tumor Tissue
MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.
OG001
MET Gene Amplifications in Tumor Tissue
MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.
OG002
MET Activating Mutations in ctDNA
MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).
OG003
MET Gene Amplifications in ctDNA
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.
PK Analysis Set consisted of all patients who received at least one dose of active study drug and had sufficient data to assess any of the PK parameters.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
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.
ID
Title
Description
OG000
Tablet 750 mg BID C1D1
Tablet formulation, 750 mg, BID, Cycle 1 Day 1
OG001
Tablet 750 mg BID C1D15
Tablet formulation, 750 mg, BID, Cycle 1 Day 15
OG002
Soft Gel 1050 mg BID C1D1
Soft Gel formulation, 1050 mg, BID, Cycle 1 Day 1
OG003
Soft Gel 1050 mg BID C1D15
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.
PK Analysis Set consisted of all patients who received at least one dose of active study drug and had sufficient data to assess any of the PK parameters. No results are reported for C2D15 because the number of observations were less than 3 for the 1050 mg BID (Soft Gel Capsule).
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
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).
ID
Title
Description
OG000
Tablet 750 mg BID C1D1
Tablet formulation, 750 mg, BID, Cycle 1 Day 1
OG001
Tablet 750 mg BID C1D15
Tablet formulation, 750 mg, BID, Cycle 1 Day 15
OG002
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.
PK Analysis Set consisted of all patients who received at least one dose of active study drug and had sufficient data to assess any of the PK parameters. No results are reported for C2D15 because the number of observations were less than 3 for the 1050 mg BID (Soft Gel Capsule).
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
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).
ID
Title
Description
OG000
Tablet 750 mg BID C1D1
Tablet formulation, 750 mg, BID, Cycle 1 Day 1
OG001
Tablet 750 mg BID C1D15
Tablet formulation, 750 mg, BID, Cycle 1 Day 15
OG002
Soft Gel 1050 mg BID C1D1
Soft Gel formulation, 1050 mg, BID, Cycle 1 Day 1
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.
PK Analysis Set consisted of all patients who received at least one dose of active study drug and had sufficient data to assess any of the PK parameters.
Posted
Geometric Mean
Geometric Coefficient of Variation
ratio
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.
ID
Title
Description
OG000
Tablet 750 mg BID C1D1
Tablet formulation, 750 mg, BID, Cycle 1 Day 1
OG001
Tablet 750 mg BID C1D15
Tablet formulation, 750 mg, BID, Cycle 1 Day 15
OG002
Soft Gel 1050 mg BID C1D1
Soft Gel formulation, 1050 mg, BID, Cycle 1 Day 1
OG003
Soft Gel 1050 mg BID C1D15
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.
PK Analysis Set consisted of all patients who received at least one dose of active study drug and had sufficient data to assess any of the PK parameters.
Posted
Geometric Mean
Geometric Coefficient of Variation
ratio
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.
ID
Title
Description
OG000
Tablet 750 mg BID C1D1
Tablet formulation, 750 mg, BID, Cycle 1 Day 1
OG001
Tablet 750 mg BID C1D15
Tablet formulation, 750 mg, BID, Cycle 1 Day 15
OG002
Soft Gel 1050 mg BID C1D1
Soft Gel formulation, 1050 mg, BID, Cycle 1 Day 1
OG003
Soft Gel 1050 mg BID C1D15
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.
PK Analysis Set consisted of all patients who received at least one dose of active study drug and had sufficient data to assess any of the PK parameters.
Posted
Geometric Mean
Geometric Coefficient of Variation
ratio
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.
ID
Title
Description
OG000
Tablet 750 mg BID C1D1
Tablet formulation, 750 mg, BID, Cycle 1 Day 1
OG001
Tablet 750 mg BID C1D15
Tablet formulation, 750 mg, BID, Cycle 1 Day 15
OG002
Soft Gel 1050 mg BID C1D1
Soft Gel formulation, 1050 mg, BID, Cycle 1 Day 1
OG003
Soft Gel 1050 mg BID C1D15
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.
PK Analysis Set consisted of all patients who received at least one dose of active study drug and had sufficient data to assess any of the PK parameters.
Posted
Median
Full Range
hours
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.
ID
Title
Description
OG000
Tablet 750 mg BID C1D1
Tablet formulation, 750 mg, BID, Cycle 1 Day 1
OG001
Tablet 750 mg BID C1D15
Tablet formulation, 750 mg, BID, Cycle 1 Day 15
OG002
Soft Gel 1050 mg BID C1D1
Soft Gel formulation, 1050 mg, BID, Cycle 1 Day 1
OG003
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.
Posted
Count of Participants
Participants
At baseline
ID
Title
Description
OG000
MET Activating Mutations
Patients with MET Activating Mutations
Units
Counts
Participants
OG000
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.
Posted
Count of Participants
Participants
At baseline
ID
Title
Description
OG000
MET Gene Amplifications
Patients with MET Gene Amplifications
Units
Counts
Participants
OG000
Secondary
Assess Change in Genetic Alteration Status in ctDNA With MGCD265 Treatment Over Time in the Selected Population
The study was closed early due to sponsor portfolio prioritization and not due to any patient safety issues. Based on limited individual patient data for whom baseline and post-treatment values were available, the statistical analyses as planned could not be performed. Screening and end of treatment detection results provided.
Posted
Number
participants
At baseline and at time of confirmation of response to treatment
ID
Title
Description
OG000
MET Activating Mutation
MET Exon 14 deletion mutation
OG001
MET Gene Amplification
MET activating mutation
Units
Counts
Participants
OG000
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
The Pharmacodynamics Evaluable Population Population defined as all patients in the mITT population for whom PD analytical results were available. Overall number of participants analyzed at baseline and post-baseline are different due to samples not being collected post-baseline for some patients.
Posted
Mean
Standard Deviation
pg/mL
Cycle 1 and Cycle 2
ID
Title
Description
OG000
MET Activating Mutations in Tumor Tissue
MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.
OG001
MET Gene Amplifications in Tumor Tissue
MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.
OG002
MET Activating Mutations in ctDNA
MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).
Time Frame
Up to 12 months
Description
All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
MET Activating Mutations in Tumor Tissue
MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.
12
28
12
28
28
28
EG001
MET Gene Amplifications in Tumor Tissue
MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.
14
20
10
20
20
20
EG002
MET Activating Mutations in ctDNA
MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).
3
8
4
8
7
8
EG003
MET Gene Amplifications in ctDNA
MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).
9
12
7
12
12
12
EG004
Total
All patients
38
68
33
68
67
68
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Myocardial Infarction
Cardiac disorders
MedDRA (21.0)
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG0030 affected12 at risk
EG0042 affected68 at risk
Colitis
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0021 affected8 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0021 affected8 at risk
EG003
Asthenia
General disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Hepatic haemorrhage
Hepatobiliary disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Bronchopulmonary aspergillosis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0021 affected8 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0013 affected20 at risk
EG0021 affected8 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0013 affected20 at risk
EG0020 affected8 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (21.0)
Systematic Assessment
EG0005 affected28 at risk
EG0015 affected20 at risk
EG0021 affected8 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Seizure
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Syncope
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0021 affected8 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Bronchial fistula
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Oesophagobronchial fistula
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Pneumothorax spontaneous
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Hypotension
Vascular disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Thrombosis
Vascular disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0021 affected8 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (21.0)
Systematic Assessment
EG0003 affected28 at risk
EG0011 affected20 at risk
EG0021 affected8 at risk
EG0031 affected12 at risk
EG0046 affected68 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected20 at risk
EG0022 affected8 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0011 affected20 at risk
EG0021 affected8 at risk
EG003
Cataract
Eye disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0021 affected8 at risk
EG003
Eye discharge
Eye disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0021 affected8 at risk
EG003
Periorbital oedema
Eye disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Vision blurred
Eye disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0021 affected8 at risk
EG003
Visual impairment
Eye disorders
MedDRA (21.0)
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0002 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0005 affected28 at risk
EG0012 affected20 at risk
EG0021 affected8 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0002 affected28 at risk
EG0011 affected20 at risk
EG0022 affected8 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0004 affected28 at risk
EG0011 affected20 at risk
EG0022 affected8 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG00022 affected28 at risk
EG00118 affected20 at risk
EG0027 affected8 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected20 at risk
EG0021 affected8 at risk
EG003
Duodenal perforation
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0011 affected20 at risk
EG0021 affected8 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0003 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0005 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0003 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0021 affected8 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG00015 affected28 at risk
EG0019 affected20 at risk
EG0026 affected8 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0007 affected28 at risk
EG0018 affected20 at risk
EG0026 affected8 at risk
EG003
Asthenia
General disorders
MedDRA (21.0)
Systematic Assessment
EG0002 affected28 at risk
EG0013 affected20 at risk
EG0021 affected8 at risk
EG003
Catheter site pain
General disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Chest discomfort
General disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Chest pain
General disorders
MedDRA (21.0)
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Face oedema
General disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected20 at risk
EG0022 affected8 at risk
EG003
Fatigue
General disorders
MedDRA (21.0)
Systematic Assessment
EG00013 affected28 at risk
EG0018 affected20 at risk
EG0025 affected8 at risk
EG003
General physical health deterioration
General disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Malaise
General disorders
MedDRA (21.0)
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0021 affected8 at risk
EG003
Oedema
General disorders
MedDRA (21.0)
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Oedema peripheral
General disorders
MedDRA (21.0)
Systematic Assessment
EG0008 affected28 at risk
EG0015 affected20 at risk
EG0023 affected8 at risk
EG003
Pain
General disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0013 affected20 at risk
EG0020 affected8 at risk
EG003
Peripheral swelling
General disorders
MedDRA (21.0)
Systematic Assessment
EG0002 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Pyrexia
General disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected20 at risk
EG0021 affected8 at risk
EG003
Bile duct obstruction
Hepatobiliary disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Perforation bile duct
Hepatobiliary disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Aspergillus infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0021 affected8 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0021 affected8 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0021 affected8 at risk
EG003
Influenza
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0021 affected8 at risk
EG003
Lung infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Mucosal infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0003 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected20 at risk
EG0021 affected8 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0021 affected8 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0021 affected8 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Spinal column injury
Injury, poisoning and procedural complications
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0021 affected8 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG00014 affected28 at risk
EG0018 affected20 at risk
EG0023 affected8 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG00012 affected28 at risk
EG0019 affected20 at risk
EG0023 affected8 at risk
EG003
Blood creatine increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0021 affected8 at risk
EG003
Blood alkaline phosphatase
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0003 affected28 at risk
EG0013 affected20 at risk
EG0022 affected8 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected20 at risk
EG0021 affected8 at risk
EG003
Capillary nail refill test abnormal
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Haemoglobin
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Inflammatory marker increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
International normalised ratio increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0003 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Platelet count decreased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0003 affected28 at risk
EG0012 affected20 at risk
EG0020 affected8 at risk
EG003
Platelet count increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0021 affected8 at risk
EG003
Transaminases increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Weight decreased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0004 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Weight increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
White blood cell count decreased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected20 at risk
EG0021 affected8 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG00012 affected28 at risk
EG0016 affected20 at risk
EG0023 affected8 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0006 affected28 at risk
EG0012 affected20 at risk
EG0020 affected8 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0012 affected20 at risk
EG0020 affected8 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0004 affected28 at risk
EG0012 affected20 at risk
EG0021 affected8 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0003 affected28 at risk
EG0011 affected20 at risk
EG0021 affected8 at risk
EG003
Hypochloraemia
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0005 affected28 at risk
EG0015 affected20 at risk
EG0021 affected8 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0009 affected28 at risk
EG0014 affected20 at risk
EG0022 affected8 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0005 affected28 at risk
EG0012 affected20 at risk
EG0020 affected8 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0011 affected20 at risk
EG0021 affected8 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0003 affected28 at risk
EG0012 affected20 at risk
EG0022 affected8 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0002 affected28 at risk
EG0012 affected20 at risk
EG0020 affected8 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0004 affected28 at risk
EG0015 affected20 at risk
EG0020 affected8 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0022 affected8 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected20 at risk
EG0021 affected8 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0011 affected20 at risk
EG0022 affected8 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0004 affected28 at risk
EG0013 affected20 at risk
EG0023 affected8 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0002 affected28 at risk
EG0011 affected20 at risk
EG0022 affected8 at risk
EG003
Headache
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0004 affected28 at risk
EG0012 affected20 at risk
EG0020 affected8 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Tremor
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Agitation
Psychiatric disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (21.0)
Systematic Assessment
EG0002 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Dysphemia
Psychiatric disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (21.0)
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Oliguria
Renal and urinary disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Urinary hesitation
Renal and urinary disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Urinary tract disorder
Renal and urinary disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0021 affected8 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0003 affected28 at risk
EG0016 affected20 at risk
EG0023 affected8 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0006 affected28 at risk
EG0018 affected20 at risk
EG0022 affected8 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Pharyngeal erythema
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0012 affected20 at risk
EG0022 affected8 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0012 affected20 at risk
EG0020 affected8 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected20 at risk
EG0021 affected8 at risk
EG003
Pulmonary congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0012 affected20 at risk
EG0021 affected8 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Rales
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Sinus pain
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Tachypnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0003 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0022 affected8 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected20 at risk
EG0021 affected8 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0021 affected8 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0004 affected28 at risk
EG0013 affected20 at risk
EG0020 affected8 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Rash generalised
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA (21.0)
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Embolism
Vascular disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Haemorrhage
Vascular disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Hot flush
Vascular disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Hypertension
Vascular disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Hypotension
Vascular disorders
MedDRA (21.0)
Systematic Assessment
EG0003 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Superior vena cava syndrome
Vascular disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected20 at risk
EG0020 affected8 at risk
EG003
Thrombosis
Vascular disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected20 at risk
EG0020 affected8 at risk
EG003
Early closure of the study is due to sponsor portfolio prioritization and not due to any patient safety issues.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
PI can not disclose, discuss, or publish study results until final manuscript has been published.
MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).
Units
Counts
Participants
OG0003
OG0013
OG0022
OG0030
Title
Denominators
Categories
Title
Measurements
OG00085(82 to 132)
OG001170(120 to 170)
OG002NA(77 to NA)Median DR and upper bound of 95% CI for median DR are not estimable. Median not reached/small number of events.
MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).
OG003
MET Gene Amplifications in ctDNA
MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).
Units
Counts
Participants
OG00028
OG00120
OG0028
OG00312
Title
Denominators
Categories
Title
Measurements
OG0003.95(2.11 to 4.18)
OG0014.84(1.35 to 5.53)
OG0023.39(1.28 to NA)Upper bound of 95% CI for median PFS is not estimable due to small number of events.
OG0032.76(1.48 to 4.01)
MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).
Units
Counts
Participants
OG00028
OG00120
OG0028
OG00312
Title
Denominators
Categories
Title
Measurements
OG00050.47(27.49 to 69.62)
OG00134.92(14.05 to 56.89)
OG00254.69(13.72 to 83.24)
OG00313.89(0.86 to 44.05)
MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).
Units
Counts
Participants
OG00028
OG00120
OG0028
OG00312
Title
Denominators
Categories
Title
Measurements
OG00016.32(4.01 to NA)Upper bound of 95% CI for median OS is not estimable due to small number of events.
OG0017.04(1.84 to 14.93)
OG002NA(.89 to NA)Median OS and upper bound of 95% CI for median OS are not estimable. Median not reached/small number of events.
OG0034.08(1.22 to 11.05)
MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).
Units
Counts
Participants
OG00028
OG00120
OG0028
OG00312
Title
Denominators
Categories
Title
Measurements
OG00028
OG00120
OG0028
OG00312
Soft Gel formulation, 1050 mg, BID, Cycle 1 Day 15
Units
Counts
Participants
OG00046
OG00130
OG00217
OG00313
Title
Denominators
Categories
Title
Measurements
OG000250.8± 98.0
OG0011565± 54.0
OG002185.5± 98.8
OG0031837± 51.3
Soft Gel 1050 mg BID C1D1
Soft Gel formulation, 1050 mg, BID, Cycle 1 Day 1
OG003
Soft Gel 1050 mg BID C1D15
Soft Gel formulation, 1050 mg, BID, Cycle 1 Day 15
OG004
Tablet 750 mg BID C2D1
Tablet formulation, 750 mg, BID, Cycle 2 Day 1
OG005
Tablet 750 mg BID C2D15
Tablet formulation, 750 mg, BID, Cycle 2 Day 15
OG006
Soft Gel 1050 mg BID C2D1
Soft Gel formulation, 1050 mg, BID, Cycle 2 Day 1
Units
Counts
Participants
OG00046
OG00130
OG00217
OG00313
OG00429
OG0055
OG0063
Title
Denominators
Categories
Title
Measurements
OG00069.77± 87.1
OG001279.2± 54.6
OG00260.49± 103.9
OG003328.1± 49.8
OG004214± 69.4
OG005138± 100.0
OG006386± 13.9
OG003
Soft Gel 1050 mg BID C1D15
Soft Gel formulation, 1050 mg, BID, Cycle 1 Day 15
OG004
Tablet 750 mg BID C2D1
Tablet formulation, 750 mg, BID, Cycle 2 Day 1
OG005
Tablet 750 mg BID C2D15
Tablet formulation, 750 mg, BID, Cycle 2 Day 15
OG006
Soft Gel 1050 mg BID C2D1
Soft Gel formulation, 1050 mg, BID, Cycle 2 Day 1
Units
Counts
Participants
OG0000
OG00136
OG0020
OG00315
OG00435
OG0055
OG0068
Title
Denominators
Categories
Title
Measurements
OG001264± 52.5
OG003337± 59.2
OG004203± 80.9
OG005255± 37.5
OG006345± 48.5
Soft Gel formulation, 1050 mg, BID, Cycle 1 Day 15
Units
Counts
Participants
OG0000
OG00130
OG0020
OG00313
Title
Denominators
Categories
Title
Measurements
OG0016.42± 87.2
OG0039.88± 96.4
Soft Gel formulation, 1050 mg, BID, Cycle 1 Day 15
Units
Counts
Participants
OG0000
OG00130
OG0020
OG00313
Title
Denominators
Categories
Title
Measurements
OG0014.07± 79.7
OG0035.35± 100.9
Soft Gel formulation, 1050 mg, BID, Cycle 1 Day 15
Units
Counts
Participants
OG0000
OG00130
OG0020
OG00313
Title
Denominators
Categories
Title
Measurements
OG0011.09± 13.4
OG0031.08± 10.4
Soft Gel 1050 mg BID C1D15
Soft Gel formulation, 1050 mg, BID, Cycle 1 Day 15
Units
Counts
Participants
OG00046
OG00130
OG00217
OG00313
Title
Denominators
Categories
Title
Measurements
OG0006.00(2.00 to 6.00)
OG0012.00(2.00 to 6.00)
OG0026.00(6.00 to 6.00)
OG0036.00(2.00 to 6.00)
11
Title
Denominators
Categories
Title
Measurements
Positive by both PCR and NGS
OG0009
Positive by PCR and Negative by NGS
OG0001
Negative by PCR and Positive by NGS
OG0001
Negative by both PCR and NGS
OG0000
21
Title
Denominators
Categories
Title
Measurements
Positive by both FISH and NGS
OG0008
Positive by FISH and Negative by NGS
OG0006
Negative by FISH and Positive by NGS
OG0007
Negative by both FISH and NGS
OG0000
2
OG0012
Title
Denominators
Categories
Detected at Screening
Title
Measurements
OG0002
OG0012
Detected at End of Treatment
Title
Measurements
OG0002
OG0011
OG003
MET Gene Amplifications in ctDNA
MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).