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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02544633




Registration number
NCT02544633
Ethics application status
Date submitted
4/09/2015
Date registered
9/09/2015

Titles & IDs
Public title
Phase 2 Study of MGCD265 in Patients With Non-Small Cell Lung Cancer With Activating Genetic Alterations in MET
Scientific 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
Secondary ID [1] 0 0
265-109
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MGCD265

Experimental: Arm 1 - MGCD265 in patients with MET activating mutations in tumor tissue

Experimental: Arm 2 - MGCD265 in patients with MET gene amplifications in tumor tissue

Experimental: Arm 3 - MGCD265 in patients with MET activating mutations in blood (circulating tumor DNA)

Experimental: Arm 4 - MGCD265 in patients with MET gene amplifications in blood (circulating tumor DNA)


Treatment: Drugs: MGCD265
MGCD265 is a small molecule multi-targeted receptor tyrosine kinase inhibitor
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate
Timepoint [1] 0 0
Up to 3 months
Secondary outcome [1] 0 0
Duration of Response
Timepoint [1] 0 0
From date of the first documentation of objective tumor response (CR or PR) to the first documentation of Objective Progression of Disease (PD) or to death due to any cause in the absence of documented PD, assessed up to 24 months.
Secondary outcome [2] 0 0
Progression Free Survival
Timepoint [2] 0 0
The time from date of first study treatment to first PD or death due to any cause in the absence of documented PD, up to 24 months.
Secondary outcome [3] 0 0
1-Year Survival Rate
Timepoint [3] 0 0
From date of first study treatment to death due to any cause, assessed up to 12 months
Secondary outcome [4] 0 0
Overall Survival
Timepoint [4] 0 0
From date of first study treatment to death due to any cause, assessed up to 24 months.
Secondary outcome [5] 0 0
Number of Patients Experiencing Treatment-emergent Adverse Events
Timepoint [5] 0 0
Date of first dose to 28 days after the last dose, up to an average of 5.1 months on treatment.
Secondary outcome [6] 0 0
Blood Plasma Concentration of MGCD265 - AUC0-6
Timepoint [6] 0 0
Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose.
Secondary outcome [7] 0 0
Blood Plasma Concentration of MGCD265 - Cmax
Timepoint [7] 0 0
Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. Cycle 2, Day 1 and Day 15 at pre-dose and at 6 hours post-dose (4-8 hours).
Secondary outcome [8] 0 0
Blood Plasma Concentration of MGCD265 - Ctrough
Timepoint [8] 0 0
Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. Cycle 2, Day 1 and Day 15 at pre-dose and at 6 hours post-dose (4-8 hours).
Secondary outcome [9] 0 0
Blood Plasma Concentration of MGCD265 - Accumulation Ratio AUC0-6
Timepoint [9] 0 0
Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose.
Secondary outcome [10] 0 0
Blood Plasma Concentration of MGCD265 - Accumulation Ratio Cmax
Timepoint [10] 0 0
Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose.
Secondary outcome [11] 0 0
Blood Plasma Concentration of MGCD265 - Peak to Trough Ratio
Timepoint [11] 0 0
Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose.
Secondary outcome [12] 0 0
Blood Plasma Concentration of MGCD265 - Tmax
Timepoint [12] 0 0
Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose.
Secondary outcome [13] 0 0
Assess Correlation Between Selected Tumor Gene Alterations Using Different Analytical Techniques in Tumor Tissue and Circulating Tumor Deoxyribonucleic Acid (ctDNA) - MET Activating Mutations
Timepoint [13] 0 0
At baseline
Secondary outcome [14] 0 0
Assess Correlation Between Selected Tumor Gene Alterations Using Different Analytical Techniques in Tumor Tissue and Circulating Tumor Deoxyribonucleic Acid (ctDNA) - MET Gene Amplifications
Timepoint [14] 0 0
At baseline
Secondary outcome [15] 0 0
Assess Change in Genetic Alteration Status in ctDNA With MGCD265 Treatment Over Time in the Selected Population
Timepoint [15] 0 0
At baseline and at time of confirmation of response to treatment
Secondary outcome [16] 0 0
Blood Plasma Concentration of Soluble MET (sMET) Biomarker
Timepoint [16] 0 0
Cycle 1 and Cycle 2

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2019
Sample size
Target
Accrual to date
Final
68
Recruitment in Australia
Recruitment state(s)
NSW,TAS,VIC
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Saint George Hospital - Kogarah
Recruitment hospital [3] 0 0
Royal North Shore Hospital - Saint Leonards
Recruitment hospital [4] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [5] 0 0
Monash Cancer Centre - Clayton
Recruitment hospital [6] 0 0
Austin Health - Heidelberg
Recruitment hospital [7] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [8] 0 0
Monash Health - Clayton
Recruitment hospital [9] 0 0
The Tweed Hospital - Tweed Heads
Recruitment hospital [10] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [4] 0 0
7000 - Hobart
Recruitment postcode(s) [5] 0 0
3165 - Clayton
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment postcode(s) [7] 0 0
5042 - Bedford Park
Recruitment postcode(s) [8] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [9] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Iowa
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Louisiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Minnesota
Country [16] 0 0
United States of America
State/province [16] 0 0
Missouri
Country [17] 0 0
United States of America
State/province [17] 0 0
New Jersey
Country [18] 0 0
United States of America
State/province [18] 0 0
New Mexico
Country [19] 0 0
United States of America
State/province [19] 0 0
New York
Country [20] 0 0
United States of America
State/province [20] 0 0
Ohio
Country [21] 0 0
United States of America
State/province [21] 0 0
Pennsylvania
Country [22] 0 0
United States of America
State/province [22] 0 0
South Carolina
Country [23] 0 0
United States of America
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Tennessee
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United States of America
State/province [24] 0 0
Texas
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United States of America
State/province [25] 0 0
Washington
Country [26] 0 0
Canada
State/province [26] 0 0
Montréal
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Hungary
State/province [27] 0 0
Komarom-esztergom
Country [28] 0 0
Hungary
State/province [28] 0 0
Budapest
Country [29] 0 0
Italy
State/province [29] 0 0
Firenze
Country [30] 0 0
Italy
State/province [30] 0 0
Lucca
Country [31] 0 0
Italy
State/province [31] 0 0
Milano
Country [32] 0 0
Italy
State/province [32] 0 0
Piacenza
Country [33] 0 0
Italy
State/province [33] 0 0
Ravenna
Country [34] 0 0
Italy
State/province [34] 0 0
Torino
Country [35] 0 0
Korea, Republic of
State/province [35] 0 0
Chungcheongbuk-do
Country [36] 0 0
Korea, Republic of
State/province [36] 0 0
Gyeonggi-do
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Korea, Republic of
State/province [37] 0 0
Daegu
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Korea, Republic of
State/province [38] 0 0
Seoul
Country [39] 0 0
Poland
State/province [39] 0 0
Pomorskie
Country [40] 0 0
Poland
State/province [40] 0 0
Warminsko-mazurskie
Country [41] 0 0
Poland
State/province [41] 0 0
Wielkopolskie
Country [42] 0 0
Taiwan
State/province [42] 0 0
Tainan CITY
Country [43] 0 0
Taiwan
State/province [43] 0 0
Tainan
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Taiwan
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Hualien City
Country [45] 0 0
Taiwan
State/province [45] 0 0
Kaohsiung
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Taiwan
State/province [46] 0 0
Taichung
Country [47] 0 0
Taiwan
State/province [47] 0 0
Taipei
Country [48] 0 0
United Kingdom
State/province [48] 0 0
England
Country [49] 0 0
United Kingdom
State/province [49] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Mirati Therapeutics Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02544633