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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02335944




Registration number
NCT02335944
Ethics application status
Date submitted
9/10/2014
Date registered
12/01/2015

Titles & IDs
Public title
Study of Safety and Efficacy of EGFR-TKI EGF816 in Combination With cMET Inhibitor INC280 in Adult Patients With EGFR Mutated Non Small Cell Lung Cancer.
Scientific title
A Phase Ib/II, Multicenter, Open-label Study of EGF816 in Combination With INC280 in Adult Patients With EGFR Mutated Non-small Cell Lung Cancer.
Secondary ID [1] 0 0
2014-000726-37
Secondary ID [2] 0 0
CINC280X2105C
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 - Capmatinib
Treatment: Drugs - Nazartinib

Experimental: Phase IB part- NSCLC with EGFR activating mutations - NSCLC participants who have previously documented EGFR mutation and progressed on EGFR TKI treatment. Participants were treated at a starting dose of 50 mg once a day for EGF816 and 200 mg twice a day for INC280 in fasted state

Experimental: Phase II- Group 1 (EGFRmut, any T790M, any MET, 2/4L antineoplastic, EGFR TKI resistant) - NSCLC participants with previously documented activating EGFR mutation, with any T790M and MET dysregulation status, who received one to three lines of systemic antineoplastic therapy prior to study entry including one line maximum of first or second generation EGFR TKI and who progressed on this EGFR TKI treatment line. Participants were treated at the RP2D of INC280 and EGF816 in fasted state

Experimental: Phase II- Group 2 (EGFRmut, de novo T790M, any MET, 1/3L antineoplastic, EGFR TKI naïve) - NSCLC participants harboring T790M mutation in de novo setting, irrespective of the activating mutation status who are treatment naïve or received maximum 2 lines of systemic antineoplastic therapy prior to study entry, but no therapy known to inhibit EGFR. Participants were treated at the RP2D of INC280 and EGF816 in fasted state

Experimental: Phase II- Group 3 (EGFRmut, T790M negative, any MET, 1L antineoplastic) - NSCLC participants with previously documented EGFR activating mutation, T790M negative, and any MET status who never received any prior line of systemic antineoplastic systemic therapy prior to study entry. Participants were treated at the RP2D of INC280 and EGF816 in fasted state

Experimental: Phase II- Group 4 (EGFRmut, any T790M, any MET, 1L (treatment naïve) 2-3L antineoplastic) - NSCLC participants with previously documented EGFR activating mutations and any T790M and MET status who were treatment naïve or failed maximum 2 prior lines of any systemic antineoplastic therapy for advanced disease. Participants were treated at the RP2D of INC280 and EGF816 in fed state

Experimental: Phase II- Group 5 (EGFRmut, T790M-, MET GCN=5, 2L, EGFR TKI resistant) - NSCLC participants with previously documented EGFR activating mutation, T790M negative, acquired MET amplification who have progressed on one prior line of therapy for advanced/metastatic NSCLC disease. Participants were to start with INC280 monotherapy (twice a day) and would have had the opportunity to continue to combination of EGF816 (once a day) and INC280 (twice a day) based on radiological disease progression evaluation by investigator's assessment per RECIST 1.1


Treatment: Drugs: Capmatinib
In the Phase 1, capmatinib was administered orally, twice per day, at a dose of 200 mg or 400 mg, in fasted state.

In the Phase II, participants received capmatinib at the RP2D (400 mg twice per day) in fasted state (Groups 1, 2 and 3) or fed state (Group 4).

Participants in Phase II Group 5 were to start with capmatinib monotherapy (fasted or fed state) and then would have had the opportunity to continue with the combination of nazartinib and capmatinib (fasted or fed state).

Treatment: Drugs: Nazartinib
In the Phase 1, nazartinib was administered orally, once a day, at a dose of 50 mg, 75 mg, 100 mg or 150 mg in fasted state.

In the Phase II, participants received nazartinib at the RP2D (100 mg once daily) in fasted state (Groups 1, 2 and 3) or fed state (Group 4). Participants in Phase II Group 5 were to start with capmatinib monotherapy (fasted or fed state) and then would have had the opportunity to continue with the combination of nazartinib and capmatinib (fasted or fed state).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase Ib: Number of Participants With Dose Limiting Toxicities (DLTs)
Timepoint [1] 0 0
Up to first 28 days of treatment
Primary outcome [2] 0 0
Phase II Group 1, 2 and 3: Overall Response Rate (ORR) by Investigator's Assessment Per RECIST 1.1
Timepoint [2] 0 0
Up to approximately 4 years
Primary outcome [3] 0 0
Phase II Group 4: Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Timepoint [3] 0 0
From start of treatment up to 30 days after last dose of study treatment, assessed up to 3.7 years
Primary outcome [4] 0 0
Phase II Group 4: Number of Participants With Dose Reductions and Dose Interruptions of INC280 and EGF618
Timepoint [4] 0 0
From start of treatment until end of treatment, assessed up to 3.6 years
Primary outcome [5] 0 0
Phase II Group 4: Dose Intensity
Timepoint [5] 0 0
From start of treatment until end of treatment, assessed up to 3.6 years
Primary outcome [6] 0 0
Phase II Group 5: ORR Per RECIST 1.1 Based on Investigator's Assessment for INC280 Monotherapy
Timepoint [6] 0 0
Up to approximately 3 years (while on INC280 monotherapy)
Secondary outcome [1] 0 0
Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of INC280 and EGF618
Timepoint [1] 0 0
From start of treatment until end of treatment, assessed up to approximately 5 years
Secondary outcome [2] 0 0
Phase II Group 1, 2 and 3: Number of Participants With Dose Reductions and Dose Interruptions of INC280 and EGF618
Timepoint [2] 0 0
From start of treatment until end of treatment, assessed up to approximately 4 years
Secondary outcome [3] 0 0
Phase Ib: Dose Intensity
Timepoint [3] 0 0
From start of treatment until end of treatment, assessed up to approximately 5 years
Secondary outcome [4] 0 0
Phase II Group 1, 2 and 3: Dose Intensity
Timepoint [4] 0 0
From start of treatment until end of treatment, assessed up to approximately 4 years
Secondary outcome [5] 0 0
Phase Ib: Overall Response Rate (ORR) Per RECIST 1.1 Based on Investigator's Assessment
Timepoint [5] 0 0
Up to approximately 5 years
Secondary outcome [6] 0 0
Phase II Group 4: Overall Response Rate (ORR) Per RECIST 1.1 Based on Investigator's Assessment
Timepoint [6] 0 0
Up to approximately 4 years
Secondary outcome [7] 0 0
Phase Ib: Progression Free Survival (PFS) Per RECIST 1.1 Based on Investigator's Assessment
Timepoint [7] 0 0
From date of first dose to first documented disease progression or death, assessed up to approximately 5 years
Secondary outcome [8] 0 0
Phase II Groups 1, 2, 3 and 4: Progression Free Survival (PFS) Per RECIST 1.1 Based on Investigator's Assessment
Timepoint [8] 0 0
From date of first dose to first documented disease progression or death, assessed up to approximately 4 years
Secondary outcome [9] 0 0
Phase Ib: Time to Response (TTR) Per RECIST 1.1 Based on Investigator's Assessment
Timepoint [9] 0 0
From the date of the first dose to the date of first documented response, up to approximately 5 years
Secondary outcome [10] 0 0
Phase II Groups 1, 2, 3 and 4: Time to Response (TTR) Per RECIST 1.1 Based on Investigator's Assessment
Timepoint [10] 0 0
From the date of the first dose to the date of first documented response, up to approximately 4 years
Secondary outcome [11] 0 0
Phase Ib: Duration of Response (DOR) Per RECIST 1.1 Based on Investigator's Assessment
Timepoint [11] 0 0
From date of first documented response to first documented disease progression or death, assessed up to approximately 5 years
Secondary outcome [12] 0 0
Phase II Groups 1, 2, 3 and 4: Duration of Response (DOR) Per RECIST 1.1 Based on Investigator's Assessment
Timepoint [12] 0 0
From date of first documented response to first documented disease progression or deaths, assessed up to approximately 4 years
Secondary outcome [13] 0 0
Phase Ib: Disease Control Rate (DCR) Per RECIST 1.1 Based on Investigator's Assessment
Timepoint [13] 0 0
Up to approximately 5 years
Secondary outcome [14] 0 0
Phase II Group 1, 2 3 and 4: Disease Control Rate (DCR) Per RECIST 1.1 Based on Investigator's Assessment
Timepoint [14] 0 0
Up to approximately 4 years
Secondary outcome [15] 0 0
Phase Ib: Overall Survival (OS)
Timepoint [15] 0 0
From date of first dose to death, assessed up to approximately 5 years
Secondary outcome [16] 0 0
Phase II Groups 1, 2, 3 and 4: Overall Survival (OS)
Timepoint [16] 0 0
From date of first dose to death, assessed up to approximately 4 years
Secondary outcome [17] 0 0
Phase Ib: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 12 Hours (AUC0-12) of INC280
Timepoint [17] 0 0
Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 2 Day 1 (Cycle=28 days)
Secondary outcome [18] 0 0
Phase Ib: Peak Plasma Concentration (Cmax) of INC280
Timepoint [18] 0 0
Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 2 Day 1 (Cycle=28 days)
Secondary outcome [19] 0 0
Phase Ib: Time to Reach Maximum Concentration (Tmax) of INC280
Timepoint [19] 0 0
Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 2 Day 1 (Cycle=28 days)
Secondary outcome [20] 0 0
Phase II Groups 3 and 4: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 12 Hours (AUC0-12) of INC280
Timepoint [20] 0 0
Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr post-dose on Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle=28 days)
Secondary outcome [21] 0 0
Phase II Groups 3 and 4: Peak Plasma Concentration (Cmax) of INC280
Timepoint [21] 0 0
Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr post-dose on Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle=28 days)
Secondary outcome [22] 0 0
Phase II Groups 3 and 4: Time to Reach Maximum Concentration (Tmax) of INC280
Timepoint [22] 0 0
Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr post-dose on Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle=28 days)
Secondary outcome [23] 0 0
Phase Ib: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) of EGF816
Timepoint [23] 0 0
Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr and 24 hr post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 2 Day 1 (Cycle=28 days)
Secondary outcome [24] 0 0
Phase Ib: Peak Plasma Concentration (Cmax) of EGF816
Timepoint [24] 0 0
Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr and 24 hr post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 2 Day 1 (Cycle=28 days)
Secondary outcome [25] 0 0
Phase Ib: Time to Reach Maximum Concentration (Tmax) of EGF816
Timepoint [25] 0 0
Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr and 24 hr post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 2 Day 1 (Cycle=28 days)
Secondary outcome [26] 0 0
Phase II Groups 3 and 4: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) of EGF816
Timepoint [26] 0 0
Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr and 24 hr post-dose on Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle=28 days)
Secondary outcome [27] 0 0
Phase II Groups 3 and 4: Peak Plasma Concentration (Cmax) of EGF816
Timepoint [27] 0 0
Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr and 24 hr post-dose on Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle=28 days)
Secondary outcome [28] 0 0
Phase II Groups 3 and 4: Time to Reach Maximum Concentration (Tmax) of EGF816
Timepoint [28] 0 0
Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr and 24 hr post-dose on Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle=28 days)
Secondary outcome [29] 0 0
Phase II Group 5: Duration of Response (DOR) Per RECIST 1.1 Based on Investigator's Assessment for INC280 Monotherapy
Timepoint [29] 0 0
From date of first documented response to the date of first documented disease progression or death, assessed up to approximately 3 years (while on INC280 monotherapy)
Secondary outcome [30] 0 0
Phase II Group 5: Disease Control Rate (DCR) Per RECIST 1.1 Based on Investigator's Assessment for INC280 Monotherapy
Timepoint [30] 0 0
Up to approximately 3 years (while on INC280 monotherapy)
Secondary outcome [31] 0 0
Phase II Group 5: Progression Free Survival (PFS) Per RECIST 1.1 Based on Investigator's Assessment for INC280 Monotherapy
Timepoint [31] 0 0
Up to approximately 3 years (while on INC280 monotherapy)
Secondary outcome [32] 0 0
Phase II Group 5: Number of Participants With Dose Modifications for INC280 Monotherapy as Well as INC280 in Combination With EGF816 Therapy
Timepoint [32] 0 0
From start of treatment until end of treatment, up to approximately 3 years
Secondary outcome [33] 0 0
Phase II Group 5: Dose Intensity for INC280 Monotherapy as Well as INC280 in Combination With EGF816 Therapy
Timepoint [33] 0 0
From start of treatment until end of treatment, up to approximately 3 years

Eligibility
Key inclusion criteria
Key Inclusion criteria:

- Participants in Phase Ib and Phase II Groups 1 to 4: histologically documented, locally advanced or recurrent (stage IIIB who were not eligible for combined modality treatment) or metastatic (Stage IV) NSCLC.

Participants in Phase II Group 5: stage IIIB/IIIC (not amenable to curative surgery, chemoradiation or radiation) or stage IV NSCLC

* Participants in Phase Ib and Phase II Groups 1 to 4: locally documented EGFR mutation L858R and/or ex19del, or a characterized de novo EGFR T790M mutation (or other rare activating mutations that confer sensitivity to 1st and 2nd generation EGFR inhibitors (e.g. L861Q, G719X, S768I), or a characterized de novo EGFRT790M mutation.
* Presence of at least one measurable lesion according to RECIST v.1.1
* ECOG performance status =1
* Participants had to be screened for HBV. Participants who were either HBsAg positive or HBV-DNA positive had to be willing and able to take antiviral therapy 1-2 weeks prior to 1st dose of EGF816 treatment and continue on antiviral therapy for at least 4 weeks after the last dose of EGF816.
* Participants had to be screened for HCV. Participants had to have negative hepatitis C antibody (HCV Ab) or were HCV Ab positive but with an undetectable level of HCV-RNA. Note: participants with detectable HCV-RNA were not eligible for the study.
* Phase Ib only: documented progression of disease according to RECIST v1.1 while on continuous treatment with EGFR TKI (e.g.: erlotinib, gefitinib or afatinib).
* Phase II Group 1 (EGFRmut, any T790M, any c-MET, 2/4L antineoplastic, EGFR TKI resistant) only: Participants demonstrated a documented clinical benefit (CR (any duration), PR (any duration), or SD for at least 6 months) on prior EGFR TKI (e.g. erlotinib, gefitinib or afatinib, and subsequently demonstrated progression according to RECIST v1.1.
* Phase II Group 2 (EGFRmut, de novo T790M, any c-MET, 1/3L antineoplastic, EGFR TKI naïve) only: Advanced NSCLC participants who were not previously treated with any therapy known to inhibit EGFR and harbor de novo T790M mutation .
* Phase II Group 3 (EGFRmut, T790M negative, any c-MET, 1L antineoplastic) only: participants had to harbor an EGFR activating mutation and had to be naïve from any line of systemic antineoplastic therapy in the advanced setting.
* Phase II Group 4 (EGFRmut, any T790M, any c-MET, 1L (treatment-naïve), 2//3L antineoplastic): All participants had to harbor an EGFR activating mutation and 2/3L participants had to have failed (defined as intolerance to treatment or documented disease progression) a maximum of 2 prior lines of antineoplastic therapy in the advanced setting
* Phase II Group 5 only: Histologically or cytologically confirmed diagnosis of NSCLC (excluding squamous cell carcinoma) with all the following:

1. EGFR mutations known to be associated with EGFR TKI sensitivity. This had to be assessed as part of the participant standard of care by a validated test for EGFR mutations, as per local regulations. Exon 19 del, L858R, either alone or in combination with other EGFR sensitivity mutation assessed by a Clinical Laboratory Improvement Amendments (CLIA) certified USA laboratory or an accredited local laboratory outside the USA had to be documented in the participant source documents before the participant consented for pre-screening for MET amplification status.
2. EGFR T790M negative status for participants who had progressed on first or second generation EGFR TKI, or third generation EGFR TKI other than osimertinib, as per tissue-based result from a CLIA-certified USA laboratory or an accredited local laboratory outside of the USA, by a validated test according to local regulations.
3. MET gene amplification defined as: Gene copy number (GCN) = 5 per tissue-based result from a CLIA-certified USA laboratory or an accredited local laboratory outside of the USA by a test that is validated according to local regulations with results documented in the participant source documents.
4. Histological transformation from NSCLC into small cell lung cancer (SCLC) following previous EGFR TKI treatment were excluded.
* Participants had to have progressed on one prior line of therapy either to first/second generation EGFR TKIs, osimertinib or other third generation EGFR TKIs for advanced/metastatic disease (stage IIIB/IIIC [not amenable to curative surgery, chemoradiation or radiation or stage IV NSCLC).
* Participants had to have a life expectancy of at least 3 months.

Key exclusion Criteria:

* Phase Ib:

* More than one previous treatment line with erlotinib, gefitinib or afatinib
* Previous treatment with any investigational agent known to inhibit EGFR (mutant or wild-type)
* Participants who had received more than three prior lines of antineoplastic therapies (including EGFR TKI) in advanced setting.
* Phase II Group 1 (EGFRmut, any T790M, any c-MET, 2/4L antineoplastic, EGFR TKI resistant):

* More than 3 prior lines of systemic antineoplastic therapies (including EGFR TKI) in the advanced setting
* More than 1 previous treatment line with 1st or 2nd generation EGFR TKI (e.g. erlotinib, gefitinib, afatinib) in the advanced setting
* Previous treatment with an investigational or marketed 3rd generation EGFR TKI (e.g. AZD9291, CO-1686, ASP8273, EGF816)
* Previous treatment with an investigational or marketed agent known to inhibit EGFR (e.g. EGF monoclonal antibody therapy, dual TKI inhibitor).
* Phase II Group 2 (EGFRmut, de novo T790M, any c-MET, 1/3L antineoplastic, EGFR TKI naïve):

* More than two previous treatment lines of systemic antineoplastic therapies in the advanced setting
* Previous treatment with an investigational or marketed agent that inhibits EGFR. EGFR inhibitors include (but not limited to) all generations of EGFR TKI (e.g.erlotinib, gefitinib, afatinib, AZD9291, CO-1686, ASP8273, EGF816) or other anti-EGFR or EGFR monoclonal antibody therapy or dual TKI inhibitors.
* Phase II Group 3 (EGFRmut, T790M negative, any c-MET, 1L antineoplastic):

* De novo EGFR T790M mutation identified by central assessment
* Previous treatment with any systemic antineoplastic therapy in the advanced setting (NSCLC stage IIIB or IV. Participants who received only one cycle of antineoplastic therapy in the advanced setting were allowed).
* Phase II Group 4 (EGFRmut, any T790M, any c-MET, 1/3L antineoplastic):

* More than 2 prior lines of systemic antineoplastic therapies in the advanced setting
* Previous treatment with an investigational or marketed 3rd generation EGFR TKI (e.g. AZD9291, CO-1686, ASP8273, EGF816)
* Previous treatment with an investigational or marketed agent known to inhibit EGFR (e.g. EGF monoclonal antibody therapy, dual TKI inhibitor).
* Previous treatment with a c-MET inhibitor or HGF-targeting therapy.
* Participants with symptomatic brain metastases.
* Phase II Group 5: Participants with symptomatic central nervous system (CNS) metastases who were neurologically unstable or had required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms.
* Presence or history of another malignancy. Exception: Participants who had been disease-free for 3 years, or participants with a history of adequately treated in-situ carcinoma of the uterine cervix, completely resected basal or squamous cell carcinoma, non-melanomatous cancer of skin, history of stage IA melanoma that had been cured, were eligible.

For Phase II Group 5: Presence or history of a malignant disease other than NSCLC that had been diagnosed and/or required therapy within the past 3 years. Exceptions to this exclusion include completely resected basal cell and squamous cell skin cancers, and completely resected carcinoma in situ of any type.

* Undergone a bone marrow or solid organ transplant.
* Known history of human immunodeficiency virus (HIV) seropositivity (HIV testing is not mandatory).

For Group 5: Participants with known history of testing positive for human immunodeficiency virus (HIV) infection, and with a history of Acquired ImmunoDeficiency Syndrome (AIDS) defining opportunistic infections in the last 12 months prior to the first dose of study treatment had to be excluded

* Participants receiving concomitant immunosuppressive agents or chronic corticosteroids used at the time of study entry except for control of brain metastases, topical applications, inhaled sprays, eye drops or local injections
* Participants with clinically significant, uncontrolled cardiovascular disease
* Presence or history of interstitial lung disease or interstitial pneumonitis
* Participants who had not recovered from all toxicities related to prior anticancer therapies to grade =1 (CTCAE v 4.03)
* Participants who had out of range laboratory values
* Participants who received live vaccines
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

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
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/01/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/11/2020
Sample size
Target
Accrual to date
Final
177
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
Canada
State/province [2] 0 0
Alberta
Country [3] 0 0
France
State/province [3] 0 0
Marseille Cedex 05
Country [4] 0 0
Germany
State/province [4] 0 0
Baden-Württemberg
Country [5] 0 0
Germany
State/province [5] 0 0
Nordrhein-Westfalen
Country [6] 0 0
Italy
State/province [6] 0 0
BO
Country [7] 0 0
Italy
State/province [7] 0 0
MO
Country [8] 0 0
Italy
State/province [8] 0 0
PG
Country [9] 0 0
Korea, Republic of
State/province [9] 0 0
Korea
Country [10] 0 0
Norway
State/province [10] 0 0
Oslo
Country [11] 0 0
Singapore
State/province [11] 0 0
Singapore
Country [12] 0 0
Spain
State/province [12] 0 0
Catalunya
Country [13] 0 0
Spain
State/province [13] 0 0
Galicia
Country [14] 0 0
Spain
State/province [14] 0 0
Las Palmas De Gran Canaria
Country [15] 0 0
Spain
State/province [15] 0 0
Madrid
Country [16] 0 0
Taiwan
State/province [16] 0 0
Taiwan ROC

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
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)?
Yes
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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/NCT02335944