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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01610336
Registration number
NCT01610336
Ethics application status
Date submitted
3/04/2012
Date registered
4/06/2012
Titles & IDs
Public title
A Safety and Efficacy Study of INC280 and Gefitinib in Patients With EGFR Mutated, c-MET-amplified NSCLC Who Have Progressed After EGFRi Treatment
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Scientific title
A Phase IB/II, Open Label, Multicenter Study of INC280 Administered Orally in Combination With Gefitinib in Adult Patients With EGFR Mutated, c-MET-amplified Non-small Cell Lung Cancer Who Have Progressed After EGFR Inhibitor Treatment
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Secondary ID [1]
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2011-002569-39
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Secondary ID [2]
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CINC280X2202
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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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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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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 - INC280
Treatment: Drugs - Gefitinib
Experimental: INC280 100 mg Cap QD Phase Ib - cap=capsule; QD=once daily
Experimental: INC280 200 mg Cap QD Phase Ib - cap=capsule; QD=once daily
Experimental: INC280 400 mg Cap QD Phase Ib - cap=capsule; QD=once daily
Experimental: INC280 800 mg Cap QD Phase Ib - cap=capsule; QD=once daily
Experimental: INC280 200 mg Cap BID Phase Ib - cap=capsule; BID=twice daily
Experimental: INC280 400 mg Cap BID Phase Ib - cap=capsule; BID=twice daily
Experimental: INC280 600 mg Cap BID Phase Ib - cap=capsule; BID=twice daily
Experimental: INC280 200 mg Tab BID Phase Ib - tab=tablet; BID=twice daily
Experimental: INC280 400 mg Tab BID Phase Ib - tab=tablet; BID=twice daily
Experimental: INC280 400 mg Cap BID Phase II - cap=capsule; BID=twice daily
Experimental: INC280 400 mg Tab BID Phase II - tab=tablet; BID=twice daily
Treatment: Drugs: INC280
During Phase Ib, INC280 was taken at escalating doses. During Phase II part, INC280 was taken at recommended Phase II dose.
Treatment: Drugs: Gefitinib
Gefitinib 250 mg taken once daily
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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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Phase Ib: Frequency of Dose Limiting Toxicities (DLTs)
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Assessment method [1]
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A dose-limiting toxicity (DLT) was defined as an adverse event or abnormal laboratory value assessed as unrelated to disease progression, inter-current illness, or concomitant medications that met certain criteria as defined in the protocol.
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Timepoint [1]
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Up to 215 weeks
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Primary outcome [2]
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Phase II : Overall Response Rate (ORR)
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Assessment method [2]
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Overall response rate is defined as the proportion of patients with best overall response (BOR) of complete response (CR) or partial response (PR), as per RECIST 1.1 (Overall Response (OR) = CR + PR).
Complete Response (CR): Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm Partial Response (PR): At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
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Timepoint [2]
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Until disease progression, up to 60.8 weeks
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Secondary outcome [1]
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Phase Ib and II: Number of Participants With Adverse Events (AEs)
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Assessment method [1]
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Adverse events were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
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Timepoint [1]
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Up to 421 weeks
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Secondary outcome [2]
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Phase Ib and II: Number of Participants With Serious Adverse Events (SAEs)
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Assessment method [2]
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Serious adverse events were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
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Timepoint [2]
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Up to 421 weeks
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Secondary outcome [3]
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Phase Ib and II: Number of Patients With Dose Reductions of INC280 by Dose Level
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Assessment method [3]
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Number of patients with dose reductions of INC280 by dose level as a measure of tolerability.
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Timepoint [3]
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Up to 417 weeks
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Secondary outcome [4]
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Phase Ib and II: Number of Patients With Dose Interruptions of Gefitinib by Dose Level
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Assessment method [4]
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Number of patients with dose interruptions of gefitinib by dose level as a measure of tolerability
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Timepoint [4]
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Up to 417 weeks
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Secondary outcome [5]
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Phase II: Overall Survival (OS)
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Assessment method [5]
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Overall survival is defined as the time from the start of treatment date to the date of death, due to any cause
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Timepoint [5]
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From date of treatment until death due to any cause, up to 70.2 months
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Secondary outcome [6]
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Phase II: Progression Free Survival (PFS)
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Assessment method [6]
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Progression-free survivalis the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause.
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Timepoint [6]
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Up to 60.8 months
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Secondary outcome [7]
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Phase II: Duration of Response (DoR)
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Assessment method [7]
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Duration of overall response (DOR) is defined as the time between the date of first documented response (CR or PR) and the date of first documented disease progression or death due to underlying cancer.
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Timepoint [7]
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Up to 23.2 months
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Secondary outcome [8]
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Phase I: PK Parameters AUCtau of INC280 and Gefitinib
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Assessment method [8]
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PK parameters were estimated from each individual plasma concentration-time profile using non-compartmental analysis.
Area under the plasma concentration-time curve (AUC) from time zero to the end of dosing interval at steady state (tau), where tau=24 hours for once daily dosing and tau=12 hours for twice daily dosing
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Timepoint [8]
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Cycle 1 day 15 (pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose) (Cycle=28 days)
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Secondary outcome [9]
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Phase I: PK Parameters Cmax of INC280 and Gefitinib
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Assessment method [9]
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PK parameters were estimated from each individual plasma concentration-time profile using non-compartmental analysis.
Cmax is the maximum observed plasma concentration of INC280 and gefitinib
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Timepoint [9]
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Cycle 1 day 15 (pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose) (Cycle=28 days)
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Secondary outcome [10]
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Phase I: PK Parameters Tmax of INC280 and Gefitinib
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Assessment method [10]
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PK parameters were estimated from each individual plasma concentration-time profile using non-compartmental analysis.
Tmax is the time to reach maximum plasma concentration of INC280 and gefitinib
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Timepoint [10]
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Cycle 1 day 15 (pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose) (Cycle=28 days)
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Secondary outcome [11]
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Phase I: PK Parameters Apparent Systemic Plasma Clearance Rate of INC280 and Gefitinib
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Assessment method [11]
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PK parameters were estimated from each individual plasma concentration-time profile using non-compartmental analysis.
Apparent systemic plasma clearance rate of INC280 and gefitinib
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Timepoint [11]
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Cycle 1 day 15 (pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose) (Cycle=28 days)
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Secondary outcome [12]
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Phase I: PK Parameters Half-life of INC280 and Gefitinib
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Assessment method [12]
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PK parameters were estimated from each individual plasma concentration-time profile using non-compartmental analysis.
The elimination half-life of INC280 and gefitinib associated with the terminal slope (Lamda_z) of a semi-logarithmic plasma concentration-time curve
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Timepoint [12]
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Cycle 1 day 15 (pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose)(Cycle=28 days)
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Eligibility
Key inclusion criteria
* Documented EGFR mutation
* Documented c-MET dysregulation
* Prior clinical benefit on EGFR inhibitors and then subsequent progression
-= 18 year old
* Life expectancy of = 3 months
* ECOG performance status = 2
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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
* Unable to swallow tables once or twice daily
* Previous treatment with c-MET inhibitor
* Any unresolved toxicity from previous anticancer therapy greater than grade 1
* History of cystic fibrosis
* History of acute or chronic pancreatitis
* Unable to undergo MRI or CT scans
* Known history of HIV
* Undergone a bone marrow or solid organ transplant
* Clinically significant wound or lung tumor lesions with increased likelihood of bleeding
* Pregnant or nursing
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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
Single group
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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
5/04/2012
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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
27/05/2020
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Sample size
Target
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Accrual to date
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Final
161
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Novartis Investigative Site - Woolloongabba
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Recruitment hospital [2]
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Novartis Investigative Site - East Bentleigh
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Recruitment hospital [3]
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Novartis Investigative Site - Auckland
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Recruitment postcode(s) [1]
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4102 - Woolloongabba
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Recruitment postcode(s) [2]
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3165 - East Bentleigh
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Recruitment postcode(s) [3]
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- Auckland
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Recruitment outside Australia
Country [1]
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Belgium
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State/province [1]
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Leuven
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Country [2]
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China
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State/province [2]
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Guangdong
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Country [3]
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China
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State/province [3]
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Shanghai
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Country [4]
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China
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State/province [4]
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Beijing
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Country [5]
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China
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State/province [5]
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Guangzhou
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Country [6]
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France
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State/province [6]
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Strasbourg Cedex
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Country [7]
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France
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State/province [7]
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Toulouse Cedex 9
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Country [8]
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Germany
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State/province [8]
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Frankfurt
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Country [9]
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Germany
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State/province [9]
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Freiburg
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Country [10]
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Israel
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State/province [10]
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Ramat Gan
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Country [11]
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Italy
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State/province [11]
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MI
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Country [12]
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Italy
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State/province [12]
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MO
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Country [13]
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Japan
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State/province [13]
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Tokyo
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Country [14]
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Korea, Republic of
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State/province [14]
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Korea
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Country [15]
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Korea, Republic of
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State/province [15]
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Seocho Gu
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Country [16]
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Korea, Republic of
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State/province [16]
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Seoul
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Country [17]
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Netherlands
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State/province [17]
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AZ
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Country [18]
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Netherlands
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State/province [18]
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Amsterdam
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Country [19]
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Netherlands
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State/province [19]
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Rotterdam
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Country [20]
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Singapore
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State/province [20]
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Singapore
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Country [21]
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Spain
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State/province [21]
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Catalunya
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Country [22]
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Spain
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State/province [22]
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Madrid
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Country [23]
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Taiwan
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State/province [23]
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Tainan
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Country [24]
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Taiwan
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State/province [24]
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Taipei
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Country [25]
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Thailand
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State/province [25]
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Bangkok
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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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
This study assessed the safety and efficacy of escalating doses INC280 when added to gefitinib in patients with lung cancer that were known to have dysregulation of the c-MET pathway and who had failed after benefiting on a prior treatment with either gefitinib or erlotinib.
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Trial website
https://clinicaltrials.gov/study/NCT01610336
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Trial related presentations / publications
Wu YL, Zhang L, Kim DW, Liu X, Lee DH, Yang JC, Ahn MJ, Vansteenkiste JF, Su WC, Felip E, Chia V, Glaser S, Pultar P, Zhao S, Peng B, Akimov M, Tan DSW. Phase Ib/II Study of Capmatinib (INC280) Plus Gefitinib After Failure of Epidermal Growth Factor Receptor (EGFR) Inhibitor Therapy in Patients With EGFR-Mutated, MET Factor-Dysregulated Non-Small-Cell Lung Cancer. J Clin Oncol. 2018 Nov 1;36(31):3101-3109. doi: 10.1200/JCO.2018.77.7326. Epub 2018 Aug 29. Erratum In: J Clin Oncol. 2019 Jan 20;37(3):261. doi: 10.1200/JCO.18.02144.
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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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)?
Yes
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What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01610336