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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
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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
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Secondary ID [1]
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265-109
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer
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0
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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0
0
0
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Lung - Non small cell
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Cancer
0
0
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0
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Objective Response Rate
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Assessment method [1]
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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.
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Timepoint [1]
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Up to 3 months
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Secondary outcome [1]
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Duration of Response
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Assessment method [1]
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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.
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Timepoint [1]
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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.
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Secondary outcome [2]
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Progression Free Survival
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Assessment method [2]
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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.
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Timepoint [2]
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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.
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Secondary outcome [3]
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1-Year Survival Rate
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Assessment method [3]
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1-Year Survival will be defined as the probability of survival at 1 year after the first dose.
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Timepoint [3]
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From date of first study treatment to death due to any cause, assessed up to 12 months
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Secondary outcome [4]
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Overall Survival
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Assessment method [4]
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Overall Survival will be defined as the time from date of first study treatment to death due to any cause
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Timepoint [4]
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From date of first study treatment to death due to any cause, assessed up to 24 months.
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Secondary outcome [5]
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Number of Patients Experiencing Treatment-emergent Adverse Events
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Assessment method [5]
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Number of patients experiencing treatment-emergent adverse events.
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Timepoint [5]
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Date of first dose to 28 days after the last dose, up to an average of 5.1 months on treatment.
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Secondary outcome [6]
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Blood Plasma Concentration of MGCD265 - AUC0-6
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Assessment method [6]
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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.
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Timepoint [6]
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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.
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Secondary outcome [7]
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Blood Plasma Concentration of MGCD265 - Cmax
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Assessment method [7]
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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.
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Timepoint [7]
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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).
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Secondary outcome [8]
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Blood Plasma Concentration of MGCD265 - Ctrough
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Assessment method [8]
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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.
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Timepoint [8]
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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).
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Secondary outcome [9]
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Blood Plasma Concentration of MGCD265 - Accumulation Ratio AUC0-6
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Assessment method [9]
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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.
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Timepoint [9]
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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.
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Secondary outcome [10]
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Blood Plasma Concentration of MGCD265 - Accumulation Ratio Cmax
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Assessment method [10]
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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.
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Timepoint [10]
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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.
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Secondary outcome [11]
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Blood Plasma Concentration of MGCD265 - Peak to Trough Ratio
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Assessment method [11]
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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.
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Timepoint [11]
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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.
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Secondary outcome [12]
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Blood Plasma Concentration of MGCD265 - Tmax
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Assessment method [12]
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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.
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Timepoint [12]
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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.
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Secondary outcome [13]
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Assess Correlation Between Selected Tumor Gene Alterations Using Different Analytical Techniques in Tumor Tissue and Circulating Tumor Deoxyribonucleic Acid (ctDNA) - MET Activating Mutations
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Assessment method [13]
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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.
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Timepoint [13]
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At baseline
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Secondary outcome [14]
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Assess Correlation Between Selected Tumor Gene Alterations Using Different Analytical Techniques in Tumor Tissue and Circulating Tumor Deoxyribonucleic Acid (ctDNA) - MET Gene Amplifications
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Assessment method [14]
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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.
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Timepoint [14]
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At baseline
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Secondary outcome [15]
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Assess Change in Genetic Alteration Status in ctDNA With MGCD265 Treatment Over Time in the Selected Population
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Assessment method [15]
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Timepoint [15]
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At baseline and at time of confirmation of response to treatment
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Secondary outcome [16]
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Blood Plasma Concentration of Soluble MET (sMET) Biomarker
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Assessment method [16]
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MET Activating Mutations in ctDNA. Change from Baseline - Cycle 2 Day 15 - Pre-Dose Standard Deviation not evaluable
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Timepoint [16]
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Cycle 1 and Cycle 2
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2019
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Sample size
Target
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Accrual to date
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Final
68
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Recruitment in Australia
Recruitment state(s)
NSW,TAS,VIC
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Recruitment hospital [1]
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Concord Repatriation General Hospital - Concord
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Recruitment hospital [2]
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Saint George Hospital - Kogarah
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Recruitment hospital [3]
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Royal North Shore Hospital - Saint Leonards
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Recruitment hospital [4]
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Royal Hobart Hospital - Hobart
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Recruitment hospital [5]
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Monash Cancer Centre - Clayton
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Recruitment hospital [6]
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Austin Health - Heidelberg
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Recruitment hospital [7]
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [8]
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Monash Health - Clayton
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Recruitment hospital [9]
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The Tweed Hospital - Tweed Heads
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Recruitment hospital [10]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment postcode(s) [1]
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2139 - Concord
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Recruitment postcode(s) [2]
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2217 - Kogarah
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Recruitment postcode(s) [3]
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2065 - Saint Leonards
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Recruitment postcode(s) [4]
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7000 - Hobart
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Recruitment postcode(s) [5]
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3165 - Clayton
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Recruitment postcode(s) [6]
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3084 - Heidelberg
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Recruitment postcode(s) [7]
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5042 - Bedford Park
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Recruitment postcode(s) [8]
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2485 - Tweed Heads
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Recruitment postcode(s) [9]
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4102 - Woolloongabba
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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United States of America
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State/province [2]
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Arkansas
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United States of America
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California
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United States of America
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Colorado
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United States of America
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State/province [5]
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Connecticut
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0
0
United States of America
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State/province [6]
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0
District of Columbia
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Country [7]
0
0
United States of America
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State/province [7]
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Florida
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Country [8]
0
0
United States of America
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State/province [8]
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Illinois
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Country [9]
0
0
United States of America
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State/province [9]
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Indiana
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0
United States of America
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Iowa
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Country [11]
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United States of America
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State/province [11]
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Kentucky
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United States of America
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Louisiana
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United States of America
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Massachusetts
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United States of America
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State/province [14]
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Michigan
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United States of America
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State/province [15]
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Minnesota
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Missouri
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New Jersey
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New Mexico
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New York
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Ohio
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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State/province [25]
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Washington
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Country [26]
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Canada
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State/province [26]
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Montréal
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Country [27]
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Hungary
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State/province [27]
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Komarom-esztergom
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Country [28]
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Hungary
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State/province [28]
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Budapest
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Country [29]
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Italy
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State/province [29]
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Firenze
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Country [30]
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Italy
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State/province [30]
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Lucca
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Italy
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State/province [31]
0
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Milano
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Country [32]
0
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Italy
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State/province [32]
0
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Piacenza
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Country [33]
0
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Italy
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State/province [33]
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Ravenna
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Country [34]
0
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Italy
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State/province [34]
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Torino
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Korea, Republic of
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Chungcheongbuk-do
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Daegu
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Korea, Republic of
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Seoul
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Poland
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Pomorskie
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Poland
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Warminsko-mazurskie
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Poland
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Wielkopolskie
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Taiwan
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State/province [42]
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Tainan CITY
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Taiwan
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State/province [43]
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Tainan
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Taiwan
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State/province [44]
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Hualien City
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0
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Taiwan
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State/province [45]
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Kaohsiung
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Taiwan
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State/province [46]
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Taichung
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0
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Taiwan
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State/province [47]
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Taipei
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Country [48]
0
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United Kingdom
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State/province [48]
0
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England
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Country [49]
0
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United Kingdom
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State/province [49]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Mirati Therapeutics Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT02544633
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/33/NCT02544633/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/33/NCT02544633/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02544633