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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01909453




Registration number
Help: Registration number
NCT01909453
Ethics application status
Help: Ethics application status
Date submitted
Help: Date submitted
24/07/2013
Date registered
Help: Date registered
26/07/2013
Date last updated
Help: Date last updated
27/02/2026

Titles & IDs
Public title
Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma
Scientific title
A 2-part Phase III Randomized, Open Label, Multicenter Study of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma
Additional trial identifiers [1] 0 0
2013-001176-38
Additional trial identifiers [2] 0 0
CMEK162B2301
Universal Trial Number (UTN)
Trial acronym
COLUMBUS
Related trial records

Health condition
Health condition(s) studied:
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Cancer 0 0 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Treatment: Drugs - LGX818
Treatment: Drugs - MEK162
Treatment: Drugs - vemurafenib

Experimental: LGX818 450 mg + MEK162 - LGX818 450 mg QD + MEK162 45 mg BID

Active comparator: Vemurafenib - Vemurafenib 960 mg BID

Experimental: LGX818 300 mg + MEK162 - LGX818 300 mg QD + MEK162 45 mg BID

Experimental: LGX818 - LGX818 300 mg QD


Treatment: Drugs: LGX818
LGX818- Orally 100 mg and 50 mg capsules

Treatment: Drugs: MEK162
MEK162- Orally 15 mg tablets

Treatment: Drugs: vemurafenib
Tablets in bottles or blisters 240 mg
Intervention code [1] 0 0
Treatment: Drugs
Description of the comparator or control
Control group

Outcomes
Primary outcome [1] 0 0
Part 1: Progression Free Survival (PFS) by BIRC in Combo 450 Group as Compared to Vemurafenib Group
Timepoint [1] 0 0
From randomization until documented disease progression (PD), initiation of new anti-cancer therapy, censoring date or death, whichever occurred first (up to 29 months)
Primary outcome [2] 0 0
Part 1: PFS by BIRC in Combo 450 Group as Compared to LGX818 Group
Timepoint [2] 0 0
From randomization until documented PD, initiation of new anti-cancer therapy, censoring date or death, whichever occurred first (up to 29 months), excluding Part 1: LGX818 300 mg group; up to 35 months for Part 1: LGX 300 mg group
Secondary outcome [1] 0 0
Part 2: PFS by BIRC in Combo 300 Group as Compared to LGX818 Group
Timepoint [1] 0 0
From randomization until documented PD, initiation of new anti-cancer therapy, censoring date or death, whichever occurred first (up to 35 months)
Secondary outcome [2] 0 0
Part 1: Overall Survival (OS)
Timepoint [2] 0 0
From randomization until censoring date/death, whichever occurred first (up to 117.8 months [M] of treatment exposure for LGX818 +MEK162; up to 111.4 months of treatment exposure for LGX818; up to 110.5 months of treatment exposure for Vemurafenib)
Secondary outcome [3] 0 0
Part 1: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) as Graded by National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03
Timepoint [3] 0 0
Baseline up to 30 days from last dose of study drug (up to 117.8 months of treatment exposure for LGX818+MEK162 45 mg [combo 450]; up to 111.4 months of treatment exposure for LGX818 300 mg; up to 110.5 months of treatment exposure for Vemurafenib 960 mg)
Secondary outcome [4] 0 0
Part 1: Number of Participants With Clinically Notable Shift From Baseline in Laboratory Parameter Values Based on NCI-CTCAE Grade, Version 4.03
Timepoint [4] 0 0
Baseline up to 30 days from last dose of study drug (up to 117.8 months of treatment exposure for LGX818+MEK162 45 mg [combo 450]; up to 111.4 months of treatment exposure for LGX818 300 mg; up to 110.5 months of treatment exposure for Vemurafenib 960 mg)
Secondary outcome [5] 0 0
Part 1: Number of Participants With Newly Occurring Notably Abnormal Vital Signs
Timepoint [5] 0 0
Baseline up to 30 days from last dose of study drug (up to 117.8 months of treatment exposure for LGX818+MEK162 45 mg [combo 450]; up to 111.4 months of treatment exposure for LGX818 300 mg; up to 110.5 months of treatment exposure for Vemurafenib 960 mg)
Secondary outcome [6] 0 0
Part 1: Number of Participants With Newly Occurring Notable Electrocardiogram (ECG) Values
Timepoint [6] 0 0
Baseline up to 30 days from last dose of study drug (up to 117.8 months of treatment exposure for LGX818+MEK162 45 mg [combo 450]; up to 111.4 months of treatment exposure for LGX818 300 mg; up to 110.5 months of treatment exposure for Vemurafenib 960 mg)
Secondary outcome [7] 0 0
Part 1: Number of Participants With Worst Post-Baseline Left Ventricular Ejection Fraction (LVEF) Values by Multigated Acquisition (MUGA) Scans or Transthoracic Echocardiograms (ECHO), by CTCAE Grade
Timepoint [7] 0 0
Baseline up to 30 days from last dose of study drug (up to 117.8 months of treatment exposure for LGX818+MEK162 45 mg [combo 450]; up to 111.4 months of treatment exposure for LGX818 300 mg; up to 110.5 months of treatment exposure for Vemurafenib 960 mg)
Secondary outcome [8] 0 0
Part 1: Number of Participants With Dermatologic-related Adverse Events of Special Interest (AESI) Graded According to the NCI-CTCAE v4.03
Timepoint [8] 0 0
Baseline up to 30 days from last dose of study drug (up to 117.8 months of treatment exposure for LGX818+MEK162 45 mg [combo 450]; up to 111.4 months of treatment exposure for LGX818 300 mg; up to 110.5 months of treatment exposure for Vemurafenib 960 mg)
Secondary outcome [9] 0 0
Part 1: Number of Participants With Ocular-related AESI Graded According to the NCI-CTCAE v4.03
Timepoint [9] 0 0
Baseline up to 30 days from last dose of study drug (up to 117.8 months of treatment exposure for LGX818+MEK162 45 mg [combo 450]; up to 111.4 months of treatment exposure for LGX818 300 mg; up to 110.5 months of treatment exposure for Vemurafenib 960 mg)
Secondary outcome [10] 0 0
Part 2: Percentage of Participants With AEs and SAEs as Graded by NCI-CTCAE, Version 4.03
Timepoint [10] 0 0
Baseline up to 30 days after last dose of study drug (up to 106.3 M of treatment exposure for Part 2: LGX818+MEK162 45 mg; up to 98.4 M of treatment exposure for Part 2: LGX818 300 mg; up to 111.4 M of treatment exposure for Part 1+Part 2: LGX818 300 mg)
Secondary outcome [11] 0 0
Part 2: Number of Participants With Clinically Notable Shift From Baseline in Laboratory Parameter Values Based on NCI-CTCAE Grade, Version 4.03
Timepoint [11] 0 0
Baseline up to 30 days after last dose of study drug (up to 106.3 M of treatment exposure for Part 2: LGX818+MEK162 45 mg; up to 98.4 M of treatment exposure for Part 2: LGX818 300 mg; up to 111.4 M of treatment exposure for Part 1+Part 2: LGX818 300 mg)
Secondary outcome [12] 0 0
Part 2: Number of Participants With Newly Occurring Notably Abnormal Vital Signs
Timepoint [12] 0 0
Baseline up to 30 days after last dose of study drug (up to 106.3 M of treatment exposure for Part 2: LGX818+MEK162 45 mg; up to 98.4 M of treatment exposure for Part 2: LGX818 300 mg; up to 111.4 M of treatment exposure for Part 1+Part 2: LGX818 300 mg)
Secondary outcome [13] 0 0
Part 2: Number of Participants With Newly Occurring Notable ECG Values
Timepoint [13] 0 0
Baseline up to 30 days after last dose of study drug (up to 106.3 M of treatment exposure for Part 2: LGX818+MEK162 45 mg; up to 98.4 M of treatment exposure for Part 2: LGX818 300 mg; up to 111.4 M of treatment exposure for Part 1+Part 2: LGX818 300 mg)
Secondary outcome [14] 0 0
Part 2: Number of Participants With Worst Post-baseline LVEF Values by MUGA Scans or Transthoracic ECHO, by CTCAE Grade
Timepoint [14] 0 0
Baseline up to 30 days after last dose of study drug (up to 106.3 M of treatment exposure for Part 2: LGX818+MEK162 45 mg; up to 98.4 M of treatment exposure for Part 2: LGX818 300 mg; up to 111.4 M of treatment exposure for Part 1+Part 2: LGX818 300 mg)
Secondary outcome [15] 0 0
Part 2: Number of Participants With Dermatologic-related AESI Graded According to the NCI-CTCAE v4.03
Timepoint [15] 0 0
Baseline up to 30 days after last dose of study drug (up to 106.3 M of treatment exposure for Part 2: LGX818+MEK162 45 mg; up to 98.4 M of treatment exposure for Part 2: LGX818 300 mg; up to 111.4 M of treatment exposure for Part 1+Part 2: LGX818 300 mg)
Secondary outcome [16] 0 0
Part 2: Number of Participants With Ocular-related AESI Graded According to the NCI-CTCAE v4.03
Timepoint [16] 0 0
Baseline up to 30 days after last dose of study drug (up to 106.3 M of treatment exposure for Part 2: LGX818+MEK162 45 mg; up to 98.4 M of treatment exposure for Part 2: LGX818 300 mg; up to 111.4 M of treatment exposure for Part 1+Part 2: LGX818 300 mg)
Secondary outcome [17] 0 0
Part (P) 2: Overall Survival (OS)
Timepoint [17] 0 0
From randomization until censoring date/death, whichever occurred 1st (up to 106.3 M of treatment exposure for P2: LGX818+MEK162 45 mg; up to 98.4 M of treatment exposure for P2: LGX818 300 mg; up to 111.4 M of treatment exposure for P1+P2: LGX818 300 mg)
Secondary outcome [18] 0 0
Part 1 and Part 2: Objective Response Rate (ORR)
Timepoint [18] 0 0
From randomization until disease progression, censoring date or death, whichever occurred first (up to 29 months for Part 1, excluding Part 1: LGX818 300 mg group; up to 35 months for Part 2 and Part 1 LGX 300 mg group)
Secondary outcome [19] 0 0
Part 1 and Part 2: Time to Objective Response (TTR)
Timepoint [19] 0 0
From randomization until disease progression, censoring date or death, whichever occurred first (up to 29 months for Part 1, excluding Part 1: LGX818 300 mg group; up to 35 months for Part 2 and Part 1 LGX 300 mg group)
Secondary outcome [20] 0 0
Part 1 and Part 2: Disease Control Rate (DCR)
Timepoint [20] 0 0
From randomization until disease progression or death, whichever occurred first (up to 29 months for Part 1, excluding Part 1: LGX818 300 mg group; up to 35 months for Part 2 and Part 1 LGX 300 mg group)
Secondary outcome [21] 0 0
Part 1 and Part 2: Duration of Response (DOR)
Timepoint [21] 0 0
From randomization until disease progression, censoring date or death, whichever occurred first (up to 29 months for Part 1, excluding Part 1: LGX818 300 mg group; up to 35 months for Part 2 and Part 1 LGX 300 mg group)
Secondary outcome [22] 0 0
Part 1 and Part 2: Time to Definitive 10% Deterioration in the Function Assessment Cancer Therapy-melanoma (FACT-M) Subscale
Timepoint [22] 0 0
Date of randomization to date of event or death due to any cause, which ever occurred first (up to 29 months for Part 1, excluding Part 1: LGX818 300 mg group; up to 35 months for Part 2 and Part 1 LGX 300 mg group)
Secondary outcome [23] 0 0
Part 1 and Part 2: Time to Definitive 10% Deterioration in the Global Health Status Score of the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC QLQ-C30)
Timepoint [23] 0 0
Date of randomization to date of event or death due to any cause, which ever occurred first (maximum up to 29 months for Part 1, excluding Part 1: LGX818 300 mg group; up to 35 months for Part 2 and Part 1 LGX 300 mg group)
Secondary outcome [24] 0 0
Part 1 and Part 2: Change From Baseline in the FACT-M Subscale at Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and End of Treatment Visit
Timepoint [24] 0 0
Baseline (Day 1 of Cycle 1), Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and end of treatment visit (within14 days after the last dose of study drug)
Secondary outcome [25] 0 0
Part 1 and Part 2: Change From Baseline in EuroQoL-5 Dimension-5 Level (EQ-5D-5L) Index Score at Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and End of Treatment Visit
Timepoint [25] 0 0
Baseline (Day 1 of Cycle 1), Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and end of treatment visit (within14 days after the last dose of study drug)
Secondary outcome [26] 0 0
Part 1 and Part 2: Change From Baseline in Global Health Status Score of EORTC QLQ-C30 at Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and End of Treatment Visit
Timepoint [26] 0 0
Baseline (Day 1 of Cycle 1), Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and end of treatment visit (within14 days after the last dose of study drug)
Secondary outcome [27] 0 0
Part 1 and Part 2: Change From Baseline in Emotional Functioning Scale Score of the EORTC QLQ-C30 at Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and End of Treatment Visit
Timepoint [27] 0 0
Baseline (Day 1 of Cycle 1), Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and end of treatment visit (within14 days after the last dose of study drug)
Secondary outcome [28] 0 0
Part 1 and Part 2: Change From Baseline in Physical Functioning Scale Score of the EORTC QLQ-C30 at Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and End of Treatment Visit
Timepoint [28] 0 0
Baseline (Day 1 of Cycle 1), Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and end of treatment visit (within14 days after the last dose of study drug)
Secondary outcome [29] 0 0
Part 1 and Part 2: Change From Baseline in Social Functioning Scale Score of the EORTC QLQ-C30 at Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and End of Treatment Visit
Timepoint [29] 0 0
Baseline (Day 1 of Cycle 1), Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and end of treatment visit (within14 days after the last dose of study drug)
Secondary outcome [30] 0 0
Part 1 and Part 2: Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG PS)
Timepoint [30] 0 0
Part 1 and Part 2: Baseline, Day 1 of each cycle (Cycle 2 to Cycle 31)
Secondary outcome [31] 0 0
Part 1: Plasma Concentrations of LGX 818
Timepoint [31] 0 0
Cycle 1 Day 1: pre-dose, 0.5, 1.5, 4 to 8 hours post dose; Cycle 2 Day 1: pre-dose; Cycle 3 Day 1: pre-dose
Secondary outcome [32] 0 0
Part 2: Plasma Concentrations of LGX 818
Timepoint [32] 0 0
Cycle 1 Day 1: pre-dose, 0.5, 1.5, 4 to 8 hours post dose; Cycle 2 Day 1: pre-dose; Cycle 3 Day 1: pre-dose
Secondary outcome [33] 0 0
Part 1: Plasma Concentrations of MEK162
Timepoint [33] 0 0
Cycle 1 Day 1: pre-dose, 0.5, 1.5, 4 to 8, hours post dose; Cycle 2 Day 1: pre-dose; Cycle 3 Day 1: pre-dose
Secondary outcome [34] 0 0
Part 2: Plasma Concentrations of MEK162
Timepoint [34] 0 0
Cycle 1 Day 1: pre-dose, 0.5, 1.5, 4 to 8, hours post dose; Cycle 2 Day 1: pre-dose; Cycle 3 Day 1: pre-dose
Secondary outcome [35] 0 0
Part 1 and Part 2: Time to Definitive 1 Point Deterioration in ECOG PS
Timepoint [35] 0 0
Baseline up to 30 days from last dose of study drug (up to 30 months for Part 1, excluding Part 1: LGX818 300 mg group; up to 36 months for Part 2 and Part 1 LGX 300 mg group)

Eligibility
Key inclusion criteria
* Diagnosis of locally advanced, unresectable or metastatic cutaneous melanoma or unknown primary melanoma (AJCC Stage IIIB, IIIC, or IV)
* Presence of BRAF V600E or V600K mutation in tumor tissue prior to randomization
* Naïve untreated patients or patients who have progressed on or after prior first line immunotherapy for resectable locally advanced or metastatic melanoma; prior adjuvant therapy is permitted (e.g. IFN, IL-2 therapy, any other immunotherapy, radiotherapy or chemotherapy), except the administration of BRAF or MEK inhibitors
* Evidence of at least one measurable lesion as detected by radiological or photographic methods
* ECOG performance status of 0 or 1
* Adequate bone marrow, organ function, cardiac and laboratory parameters
* Normal functioning of daily living activities
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
* Any untreated central nervous system (CNS) lesion
* Uveal and mucosal melanoma
* History of leptomeningeal metastases
* History of or current evidence of central serous retinopathy (CSR), retinal vein occlusion (RVO) or history of retinal degenerative disease
* Any previous systemic chemotherapy treatment, extensive radiotherapy or investigational agent other than immunotherapy, or patients who have received more than one line of immunotherapy for locally advanced unresectable or metastatic melanoma; Ipilimumab (adjuvant) or other immunotherapy treatment must have ended at least 6 weeks prior to randomization
* History of Gilbert's syndrome
* Prior therapy with a BRAF inhibitor and/or a MEK- inhibitor
* Impaired cardiovascular function or clinically significant cardiovascular diseases
* Uncontrolled arterial hypertension despite medical treatment
* HIV positive or active Hepatitis B, and/or active Hepatitis C
* Impairment of gastrointestinal function
* Patients with neuromuscular disorders that are associated with elevated CK
* Pregnant or nursing (lactating) women
* Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study

Other protocol-defined inclusion/exclusion criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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 3
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
12/09/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/09/2024
Sample size
Target
Accrual to date
Final
921
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Lake Macquarie Private Hospital - Gateshead
Recruitment hospital [2] 0 0
Tasman Oncology Research - Southport
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 0 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [5] 0 0
The Alfred Hospital - Prahran
Recruitment hospital [6] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
02290 - Gateshead
Recruitment postcode(s) [2] 0 0
4215 - Southport
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
5011 - Woodville
Recruitment postcode(s) [5] 0 0
3004 - Prahran
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
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
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
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Illinois
Country [8] 0 0
United States of America
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Indiana
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United States of America
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Michigan
Country [10] 0 0
United States of America
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Mississippi
Country [11] 0 0
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Nebraska
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New Jersey
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New York
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United States of America
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Oklahoma
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Pennsylvania
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South Dakota
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Tennessee
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United States of America
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Texas
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United States of America
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Vermont
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United States of America
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Virginia
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United States of America
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Washington
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autónoma de Buenosaires
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Brazil
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Estado de Bahia
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Brazil
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Pernambuco
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Brazil
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Rio Grande do Sul
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Brazil
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São Paulo
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Brazil
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Natal
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Brazil
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Rio de Janeiro
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Canada
State/province [30] 0 0
Alberta
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Canada
State/province [31] 0 0
Ontario
Country [32] 0 0
Canada
State/province [32] 0 0
Quebec
Country [33] 0 0
Canada
State/province [33] 0 0
Québec
Country [34] 0 0
Colombia
State/province [34] 0 0
Bogota D.C.
Country [35] 0 0
Czechia
State/province [35] 0 0
Moravskoslezský kraj
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Czechia
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Praha, Hlavní Mesto
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Czechia
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South Moravian
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Czechia
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Olomouc
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Czechia
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Prague
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France
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Isère
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France
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NORD
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France
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Rhone
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France
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Sarthe
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France
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Val-de-marne
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France
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Bordeaux
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France
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Boulogne-Billancourt
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France
State/province [47] 0 0
Nice
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France
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Paris
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France
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Pierre-Bénite
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France
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Reims
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France
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Strasbourg
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Germany
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Baden-Wurttemberg
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Germany
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Bavaria
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Germany
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Hesse
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Lower Saxony
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Germany
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North Rhine-Westphalia
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Germany
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Rhineland-Palatinate
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Germany
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Saxony
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Germany
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Saxony-Anhalt
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Germany
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Schleswig-Holstein
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Germany
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Berlin
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Germany
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Bonn
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Germany
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Dresden
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Germany
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Erfurt
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Germany
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Essen
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Germany
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Frankfurt am Main
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Germany
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Freiburg im Breisgau
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Germany
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Gera
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Germany
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Hamburg
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Germany
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Hanover
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Germany
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Heidelberg
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Germany
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Homburg
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Germany
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Kiel
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Germany
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Mannheim
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Germany
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Minden
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Germany
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Münster
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Germany
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Nuremberg
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Germany
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Regensburg
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Germany
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Tübingen
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Germany
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Ulm
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Greece
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Athens
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Greece
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Neo Faliro
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Hungary
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Hajdú-Bihar
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Hungary
State/province [84] 0 0
Budapest
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Hungary
State/province [85] 0 0
Szolnok
Country [86] 0 0
Israel
State/province [86] 0 0
Tel Aviv
Country [87] 0 0
Israel
State/province [87] 0 0
Haifa
Country [88] 0 0
Israel
State/province [88] 0 0
Jerusalem
Country [89] 0 0
Italy
State/province [89] 0 0
Ancona
Country [90] 0 0
Italy
State/province [90] 0 0
Campania
Country [91] 0 0
Italy
State/province [91] 0 0
Emilia-Romagna
Country [92] 0 0
Italy
State/province [92] 0 0
Lazio
Country [93] 0 0
Italy
State/province [93] 0 0
Lombardy
Country [94] 0 0
Italy
State/province [94] 0 0
Torino
Country [95] 0 0
Italy
State/province [95] 0 0
Tuscany
Country [96] 0 0
Italy
State/province [96] 0 0
Umbria
Country [97] 0 0
Italy
State/province [97] 0 0
Veneto
Country [98] 0 0
Italy
State/province [98] 0 0
Bari
Country [99] 0 0
Italy
State/province [99] 0 0
Bergamo
Country [100] 0 0
Italy
State/province [100] 0 0
Genoa
Country [101] 0 0
Italy
State/province [101] 0 0
Milan
Country [102] 0 0
Italy
State/province [102] 0 0
Napoli
Country [103] 0 0
Italy
State/province [103] 0 0
Padua
Country [104] 0 0
Italy
State/province [104] 0 0
Pavia
Country [105] 0 0
Italy
State/province [105] 0 0
Ragusa
Country [106] 0 0
Italy
State/province [106] 0 0
Rome
Country [107] 0 0
Italy
State/province [107] 0 0
Siena
Country [108] 0 0
Italy
State/province [108] 0 0
Udine
Country [109] 0 0
Japan
State/province [109] 0 0
Fukuoka
Country [110] 0 0
Japan
State/province [110] 0 0
Nagano
Country [111] 0 0
Japan
State/province [111] 0 0
Niigata
Country [112] 0 0
Japan
State/province [112] 0 0
Tokyo
Country [113] 0 0
Japan
State/province [113] 0 0
Ôsaka
Country [114] 0 0
Mexico
State/province [114] 0 0
Mexico City
Country [115] 0 0
Mexico
State/province [115] 0 0
Nuevo León
Country [116] 0 0
Mexico
State/province [116] 0 0
Quintana Roo
Country [117] 0 0
Mexico
State/province [117] 0 0
México
Country [118] 0 0
Netherlands
State/province [118] 0 0
Gelderland
Country [119] 0 0
Netherlands
State/province [119] 0 0
North Brabant
Country [120] 0 0
Netherlands
State/province [120] 0 0
North Holland
Country [121] 0 0
Netherlands
State/province [121] 0 0
Overijssel
Country [122] 0 0
Netherlands
State/province [122] 0 0
Provincie Friesland
Country [123] 0 0
Netherlands
State/province [123] 0 0
Ariënsplein Enschede
Country [124] 0 0
Netherlands
State/province [124] 0 0
Enschede
Country [125] 0 0
Netherlands
State/province [125] 0 0
Groningen
Country [126] 0 0
Netherlands
State/province [126] 0 0
Heerlen
Country [127] 0 0
Netherlands
State/province [127] 0 0
Leiden
Country [128] 0 0
Netherlands
State/province [128] 0 0
Maastricht
Country [129] 0 0
Netherlands
State/province [129] 0 0
Rotterdam
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Norway
State/province [130] 0 0
Oslo
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Poland
State/province [131] 0 0
Masovian Voivodeship
Country [132] 0 0
Poland
State/province [132] 0 0
Warsaw
Country [133] 0 0
Portugal
State/province [133] 0 0
Lisbon District
Country [134] 0 0
Portugal
State/province [134] 0 0
Setúbal District
Country [135] 0 0
Portugal
State/province [135] 0 0
Lisbon
Country [136] 0 0
Portugal
State/province [136] 0 0
Porto
Country [137] 0 0
Russia
State/province [137] 0 0
Moscow
Country [138] 0 0
Russia
State/province [138] 0 0
Ryazan
Country [139] 0 0
Russia
State/province [139] 0 0
Saint Petersburg
Country [140] 0 0
Singapore
State/province [140] 0 0
Singapore
Country [141] 0 0
Slovakia
State/province [141] 0 0
Bratislava
Country [142] 0 0
Slovakia
State/province [142] 0 0
Poprad
Country [143] 0 0
South Africa
State/province [143] 0 0
Pretoria
Country [144] 0 0
South Korea
State/province [144] 0 0
Seoul Teugbyeolsi
Country [145] 0 0
South Korea
State/province [145] 0 0
Seoul-teukbyeolsi [seoul]
Country [146] 0 0
South Korea
State/province [146] 0 0
Seoul
Country [147] 0 0
Spain
State/province [147] 0 0
Andalusia
Country [148] 0 0
Spain
State/province [148] 0 0
Barcelona
Country [149] 0 0
Spain
State/province [149] 0 0
Catalonia
Country [150] 0 0
Spain
State/province [150] 0 0
Madrid
Country [151] 0 0
Spain
State/province [151] 0 0
Murcia
Country [152] 0 0
Spain
State/province [152] 0 0
Navarre
Country [153] 0 0
Spain
State/province [153] 0 0
Principality of Asturias
Country [154] 0 0
Spain
State/province [154] 0 0
Sevilla
Country [155] 0 0
Spain
State/province [155] 0 0
A Coruña
Country [156] 0 0
Spain
State/province [156] 0 0
Alicante
Country [157] 0 0
Spain
State/province [157] 0 0
Donostia / San Sebastian
Country [158] 0 0
Spain
State/province [158] 0 0
Granada
Country [159] 0 0
Spain
State/province [159] 0 0
Lleida
Country [160] 0 0
Spain
State/province [160] 0 0
Málaga
Country [161] 0 0
Spain
State/province [161] 0 0
Santa Cruz de Tenerife
Country [162] 0 0
Spain
State/province [162] 0 0
Seville
Country [163] 0 0
Spain
State/province [163] 0 0
Valencia
Country [164] 0 0
Sweden
State/province [164] 0 0
Gävle
Country [165] 0 0
Sweden
State/province [165] 0 0
Gothenburg
Country [166] 0 0
Sweden
State/province [166] 0 0
Linköping
Country [167] 0 0
Sweden
State/province [167] 0 0
Lund
Country [168] 0 0
Sweden
State/province [168] 0 0
Solna
Country [169] 0 0
Sweden
State/province [169] 0 0
Uppsala
Country [170] 0 0
Switzerland
State/province [170] 0 0
Bern
Country [171] 0 0
Switzerland
State/province [171] 0 0
Zurich Flughafen
Country [172] 0 0
Turkey (Türkiye)
State/province [172] 0 0
Ankara
Country [173] 0 0
Turkey (Türkiye)
State/province [173] 0 0
Bornova
Country [174] 0 0
Turkey (Türkiye)
State/province [174] 0 0
Izmir
Country [175] 0 0
United Kingdom
State/province [175] 0 0
Cambridgeshire
Country [176] 0 0
United Kingdom
State/province [176] 0 0
Chelsea
Country [177] 0 0
United Kingdom
State/province [177] 0 0
London, CITY of
Country [178] 0 0
United Kingdom
State/province [178] 0 0
Surrey
Country [179] 0 0
United Kingdom
State/province [179] 0 0
Wirral
Country [180] 0 0
United Kingdom
State/province [180] 0 0
YORK
Country [181] 0 0
United Kingdom
State/province [181] 0 0
Broomfield
Country [182] 0 0
United Kingdom
State/province [182] 0 0
Leeds
Country [183] 0 0
United Kingdom
State/province [183] 0 0
London
Country [184] 0 0
United Kingdom
State/province [184] 0 0
Manchester
Country [185] 0 0
United Kingdom
State/province [185] 0 0
Oxford
Country [186] 0 0
United Kingdom
State/province [186] 0 0
Preston

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

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
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?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


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/NCT01909453