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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02075840




Registration number
NCT02075840
Ethics application status
Date submitted
27/02/2014
Date registered
3/03/2014
Date last updated
22/04/2025

Titles & IDs
Public title
A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants
Scientific title
Randomized, Multicenter, Phase III, Open-Label Study of Alectinib Versus Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer
Secondary ID [1] 0 0
2013-004133-33
Secondary ID [2] 0 0
BO28984
Universal Trial Number (UTN)
Trial acronym
ALEX
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 - Alectinib
Treatment: Drugs - Crizotinib

Experimental: Alectinib - Participants will receive alectinib from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.

Active comparator: Crizotinib - Participants will receive crizotinib from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.


Treatment: Drugs: Alectinib
Participants will receive alectinib 600 mg orally (four 150 mg capsules) BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.

Treatment: Drugs: Crizotinib
Participants will receive crizotinib 250 mg capsules orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) by Investigator Assessment
Assessment method [1] 0 0
PFS was assessed as time to disease progression or death whichever occurred first by investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 millimeter (mm) and the appearance of new lesions.
Timepoint [1] 0 0
Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)
Primary outcome [2] 0 0
Percentage of Participants With PFS Event by Investigator Assessment
Assessment method [2] 0 0
PFS was assessed percentage of participants with disease progression or death whichever occurred first by investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 millimeter (mm) and the appearance of new lesions.
Timepoint [2] 0 0
Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)
Secondary outcome [1] 0 0
PFS Independent Review Committee (IRC)-Assessed
Assessment method [1] 0 0
PFS was assessed as time to disease progression or death whichever occurred first by IRC assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 mm and the appearance of new lesions.
Timepoint [1] 0 0
Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)
Secondary outcome [2] 0 0
Percentage of Participants With PFS Event by IRC
Assessment method [2] 0 0
PFS was assessed as percentage of participants with disease progression or death whichever occurred first by IRC assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 mm and the appearance of new lesions.
Timepoint [2] 0 0
Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)
Secondary outcome [3] 0 0
Percentage of Participants With Central Nervous System (CNS) Progression as Determined by IRC Using RECIST V1.1 Criteria
Assessment method [3] 0 0
CNS progression was assessed as percentage of participants with an event defined as time from randomization until first radiographic evidence of CNS progression by IRC. The risk for a CNS progression without a prior non-CNS progression with alectinib compared with crizotinib.
Timepoint [3] 0 0
Randomization to CNS PD as first occurrence of disease progression (assessed every 8 weeks up to 33 months)
Secondary outcome [4] 0 0
Percentage of Participants With Central Nervous System (CNS) Progression as Determined by IRC Using Revised Assessment in Neuro Oncology (RANO) Criteria
Assessment method [4] 0 0
CNS progression was assessed as percentage of participants with event defined as time from randomization until first radiographic evidence of CNS progression by IRC. The risk for a CNS progression without a prior non-CNS progression with alectinib compared with crizotinib.
Timepoint [4] 0 0
Randomization to the first occurrence of disease progression in the CNS (assessed every 8 weeks up to 33 months)
Secondary outcome [5] 0 0
Percentage of Participants With Objective Response Rate (ORR) of Complete Response (CR) or Partial Response (PR) as Determined by The Investigators According to RECIST V1.1 Criteria
Assessment method [5] 0 0
ORR was defined as the percentage of participants who attained CR or PR. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
Timepoint [5] 0 0
Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)
Secondary outcome [6] 0 0
Duration of Response (DOR) According to RECIST V1.1 Criteria as Assessed by the Investigators
Assessment method [6] 0 0
DOR was defined as the time from when response (CR or PR) was first documented to first documented disease progression or death, whichever occurred first. DOR was evaluated for participants who had a best overall response (BOR) of CR or PR.
Timepoint [6] 0 0
First occurrence of objective response to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)
Secondary outcome [7] 0 0
Overall Survival (OS)
Assessment method [7] 0 0
Overall survival (OS) was defined as the time from randomization to death from any cause.
Timepoint [7] 0 0
From randomization until death (up to 43 months)
Secondary outcome [8] 0 0
Percentage of Participants With OS Event
Assessment method [8] 0 0
Overall survival (OS) was defined as the time from randomization to death from any cause.
Timepoint [8] 0 0
From randomization until death (up to 43 months)
Secondary outcome [9] 0 0
Percentage of Participants With CNS ORR of CR or PR IRC-assessed According to RECIST v1.1 Criteria
Assessment method [9] 0 0
CNS ORR was defined as the percentage of participants who attained CR or PR and had measurable/non-measurable CNS lesions at baseline. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
Timepoint [9] 0 0
Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)
Secondary outcome [10] 0 0
CNS DOR IRC-assessed According to RECIST v1.1 Criteria
Assessment method [10] 0 0
CNS DOR was defined as the time from when response (CR or PR) was first documented to first documented disease progression or death, whichever occurred first. DOR was evaluated for participants who had a best overall response (BOR) of CR or PR.
Timepoint [10] 0 0
First occurrence of CNS objective response to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)
Secondary outcome [11] 0 0
Percentage of Participants With Adverse Events
Assessment method [11] 0 0
An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Timepoint [11] 0 0
Baseline up to 28 months in the crizotinib arm and up to 30 months in the alectinib arm
Secondary outcome [12] 0 0
Area Under The Concentration-Time Curve (AUC) of Alectinib
Assessment method [12] 0 0
Timepoint [12] 0 0
Pre-dose (within 2 hours before alectinib) (baseline), 1, 2, 4, 6, and 8 hours post-dose at Visit 0 (first dosing day) and Week 4; Pre-dose (within 2 hours) at Week 8, then every 8 weeks until disease progression or death/withdrawal (up to 33 months)
Secondary outcome [13] 0 0
Maximum Concentration (Cmax) of Alectinib
Assessment method [13] 0 0
Timepoint [13] 0 0
Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months)
Secondary outcome [14] 0 0
Time to Reach Cmax (Tmax) of Alectinib
Assessment method [14] 0 0
Timepoint [14] 0 0
Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months)
Secondary outcome [15] 0 0
AUC of Alectinib Metabolite
Assessment method [15] 0 0
Timepoint [15] 0 0
Pre-dose (within 2 hours before alectinib) (baseline), 1, 2, 4, 6, and 8 hours post-dose at Visit 0 (first dosing day) and Week 4; Pre-dose (within 2 hours) at Week 8, then every 8 weeks until disease progression or death/withdrawal (up to 33 months)
Secondary outcome [16] 0 0
Cmax of Alectinib Metabolite
Assessment method [16] 0 0
Timepoint [16] 0 0
Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months)
Secondary outcome [17] 0 0
Tmax of Alectinib Metabolite
Assessment method [17] 0 0
Timepoint [17] 0 0
Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months)
Secondary outcome [18] 0 0
Time to Deterioration by European Organization for The Research And Treatment of Cancer (EORTC) Quality Of Life Questionnaire Core 30 (C30)
Assessment method [18] 0 0
The EORTC QLQ-30 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in global health status or function is defined as a \>or=10-point decrease from baseline in a symptom score that must be held for at least two consecutive assessments or an initial \>or=10-point decrease from baseline followed by death within 5 weeks from the last assessment.
Timepoint [18] 0 0
Baseline, every 4 weeks until disease progression (up to 33 months)
Secondary outcome [19] 0 0
Percentage of Participants With Deterioration by EORTC Quality Of Life Questionnaire Core 30 (C30)
Assessment method [19] 0 0
The EORTC QLQ-30 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in global health status or function is defined as a \>or=10-point decrease from baseline in a symptom score that must be held for at least two consecutive assessments or an initial \>or=10-point decrease from baseline followed by death within 5 weeks from the last assessment.
Timepoint [19] 0 0
Baseline, every 4 weeks until disease progression (up to 33 months)
Secondary outcome [20] 0 0
Time to Deterioration by EORTC Quality of Life Questionnaire Lung Cancer Module 13 (LC13)
Assessment method [20] 0 0
The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in lung cancer symptoms is defined as a \>or=10-point increase from baseline in a symptom score that must be held for at least two consecutive assessments or an initial \>or=10-point increase above baseline followed by death within 5 weeks from the last assessment.
Timepoint [20] 0 0
Baseline, every 4 weeks until disease progression (up to 33 months)
Secondary outcome [21] 0 0
Percentage of Participants With Deterioration by EORTC Quality of Life Questionnaire Lung Cancer Module 13 (LC13)
Assessment method [21] 0 0
The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in lung cancer symptoms is defined as a \>or=10-point increase from baseline in a symptom score that must be held for at least two consecutive assessments or an initial \>or=10-point increase above baseline followed by death within 5 weeks from the last assessment.
Timepoint [21] 0 0
Baseline, every 4 weeks until disease progression (up to 33 months)
Secondary outcome [22] 0 0
Health-Related Quality of Life (HRQoL) by EORTC Quality of Life Questionnaire C30 Score
Assessment method [22] 0 0
The EORTC QLQ-C30 questionnaire consisted of 30 questions generating five functional scores (physical, role, cognitive, emotional, and social); a global health status/global quality of life scale score; three symptom scale scores (fatigue, pain, and nausea and vomiting); and six stand alone one-item scores that capture additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and perceived financial burden. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.
Timepoint [22] 0 0
Baseline, every 4 weeks until disease progression (up to 33 months)
Secondary outcome [23] 0 0
HRQoL by EORTC Quality of Life Questionnaire LC13 Score Coughing
Assessment method [23] 0 0
The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.
Timepoint [23] 0 0
Baseline, every 4 weeks until disease progression (up to 33 months)
Secondary outcome [24] 0 0
HRQoL by EORTC Quality of Life Questionnaire LC13 Score Dyspnoea
Assessment method [24] 0 0
The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.
Timepoint [24] 0 0
Baseline, every 4 weeks until disease progression (up to 33 months)
Secondary outcome [25] 0 0
HRQoL by EORTC Quality of Life Questionnaire LC13 Score Pain in Chest
Assessment method [25] 0 0
The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.
Timepoint [25] 0 0
Baseline, every 4 weeks until disease progression (up to 33 months)
Secondary outcome [26] 0 0
HRQoL by EORTC Quality of Life Questionnaire LC13 Score Pain in Arm and Shoulder
Assessment method [26] 0 0
The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.
Timepoint [26] 0 0
Baseline, every 4 weeks until disease progression (up to 33 months)

Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive as assessed by the Ventana immunohistochemistry (IHC) test
* Life expectancy of at least 12 weeks
* Eastern cooperative oncology group performance status (ECOG PS) of 0-2
* Participants with no prior systemic treatment for advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC
* Adequate renal, and hematologic function
* Participants must have recovered from effects of any major surgery or significant traumatic injury at least 28 days before the first dose of study treatment
* Measurable disease by response evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1) prior to the administration of study treatment
* Prior brain or leptomeningeal metastases allowed if asymptomatic (e.g., diagnosed incidentally at study baseline)
* Negative pregnancy test for all females of child bearing potential
* Use of highly effective contraception as defined by the study protocol
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants with a previous malignancy within the past 3 years
* Any gastrointestinal (GI) disorder or liver disease
* National cancer institute common terminology criteria for adverse events (NCI CTCAE) (version 4.0) Grade 3 or higher toxicities due to any prior therapy (e.g., radiotherapy) (excluding alopecia)
* History of organ transplant
* Co-administration of anti-cancer therapies other than those administered in this study
* Participants with baseline QTc greater than (>) 470 milliseconds or symptomatic bradycardia
* Recipient of strong/potent cytochrome P4503A inhibitors or inducers within 14 days prior to the first dose until the end of study treatment
* Recipient of any drug with potential QT interval prolonging effects within 14 days prior to the first dose for all participants and while on treatment through the end of the study for crizotinib-treated participants only
* History of hypersensitivity to any of the additives in the alectinib and crizotinib drug formulation
* Pregnancy or lactation
* Any clinically significant disease or condition (or history of) that could interfere with, or for which the treatment might interfere with, the conduct of the study or the absorption of oral medications or that would, in the opinion of the principal investigator, pose an unacceptable risk to the participant in this study
* Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the participant before trial entry

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
19/08/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/04/2025
Sample size
Target
Accrual to date
Final
303
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Kinghorn Cancer Centre - Darlinghurst
Recruitment hospital [2] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [4] 0 0
Queen Elizabeth Hospital - Adelaide
Recruitment hospital [5] 0 0
Monash Health Translational Precinct - Victoria
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
2298 - Waratah
Recruitment postcode(s) [4] 0 0
5011 - Adelaide
Recruitment postcode(s) [5] 0 0
3168 - Victoria
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
Tennessee
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
Bosnia and Herzegovina
State/province [9] 0 0
Sarajevo
Country [10] 0 0
Brazil
State/province [10] 0 0
São Paulo
Country [11] 0 0
Canada
State/province [11] 0 0
Alberta
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Canada
State/province [13] 0 0
Saskatchewan
Country [14] 0 0
Chile
State/province [14] 0 0
Santiago
Country [15] 0 0
China
State/province [15] 0 0
Guangzhou
Country [16] 0 0
China
State/province [16] 0 0
Shanghai
Country [17] 0 0
Costa Rica
State/province [17] 0 0
San Jose
Country [18] 0 0
Egypt
State/province [18] 0 0
Cairo
Country [19] 0 0
France
State/province [19] 0 0
Grenoble
Country [20] 0 0
France
State/province [20] 0 0
Lille
Country [21] 0 0
France
State/province [21] 0 0
Lyon
Country [22] 0 0
France
State/province [22] 0 0
Pessac
Country [23] 0 0
Guatemala
State/province [23] 0 0
Guatemala City
Country [24] 0 0
Hong Kong
State/province [24] 0 0
Hong Kong
Country [25] 0 0
Israel
State/province [25] 0 0
Haifa
Country [26] 0 0
Israel
State/province [26] 0 0
Kfar Saba
Country [27] 0 0
Italy
State/province [27] 0 0
Emilia-Romagna
Country [28] 0 0
Italy
State/province [28] 0 0
Lazio
Country [29] 0 0
Italy
State/province [29] 0 0
Lombardia
Country [30] 0 0
Italy
State/province [30] 0 0
Puglia
Country [31] 0 0
Italy
State/province [31] 0 0
Sicilia
Country [32] 0 0
Italy
State/province [32] 0 0
Umbria
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Gyeonggi-do
Country [34] 0 0
Korea, Republic of
State/province [34] 0 0
Seoul
Country [35] 0 0
Mexico
State/province [35] 0 0
Mexico CITY (federal District)
Country [36] 0 0
New Zealand
State/province [36] 0 0
Auckland
Country [37] 0 0
Poland
State/province [37] 0 0
Gda?sk
Country [38] 0 0
Poland
State/province [38] 0 0
Lublin
Country [39] 0 0
Poland
State/province [39] 0 0
Olsztyn
Country [40] 0 0
Poland
State/province [40] 0 0
Otwock
Country [41] 0 0
Poland
State/province [41] 0 0
Warszawa
Country [42] 0 0
Portugal
State/province [42] 0 0
Coimbra
Country [43] 0 0
Portugal
State/province [43] 0 0
Lisboa
Country [44] 0 0
Portugal
State/province [44] 0 0
Porto
Country [45] 0 0
Russian Federation
State/province [45] 0 0
Moskovskaja Oblast
Country [46] 0 0
Russian Federation
State/province [46] 0 0
Sankt Petersburg
Country [47] 0 0
Russian Federation
State/province [47] 0 0
Moscow
Country [48] 0 0
Serbia
State/province [48] 0 0
Belgrade
Country [49] 0 0
Serbia
State/province [49] 0 0
Sremska Kamenica
Country [50] 0 0
Singapore
State/province [50] 0 0
Singapore
Country [51] 0 0
Spain
State/province [51] 0 0
Alicante
Country [52] 0 0
Spain
State/province [52] 0 0
Barcelona
Country [53] 0 0
Spain
State/province [53] 0 0
Madrid
Country [54] 0 0
Spain
State/province [54] 0 0
Sevilla
Country [55] 0 0
Switzerland
State/province [55] 0 0
Basel
Country [56] 0 0
Switzerland
State/province [56] 0 0
Bern
Country [57] 0 0
Switzerland
State/province [57] 0 0
Lausanne
Country [58] 0 0
Switzerland
State/province [58] 0 0
Zürich
Country [59] 0 0
Taiwan
State/province [59] 0 0
Taichung
Country [60] 0 0
Taiwan
State/province [60] 0 0
Tainan
Country [61] 0 0
Taiwan
State/province [61] 0 0
Taipei
Country [62] 0 0
Thailand
State/province [62] 0 0
Bangkok
Country [63] 0 0
Thailand
State/province [63] 0 0
Chiang Rai
Country [64] 0 0
Thailand
State/province [64] 0 0
Khonkaen
Country [65] 0 0
Thailand
State/province [65] 0 0
Patumwan
Country [66] 0 0
Thailand
State/province [66] 0 0
Songkla
Country [67] 0 0
Turkey
State/province [67] 0 0
Adana
Country [68] 0 0
Turkey
State/province [68] 0 0
Ankara
Country [69] 0 0
Turkey
State/province [69] 0 0
Edirne
Country [70] 0 0
Turkey
State/province [70] 0 0
Malatya
Country [71] 0 0
Ukraine
State/province [71] 0 0
Kyiv
Country [72] 0 0
Ukraine
State/province [72] 0 0
Lviv
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Birmingham
Country [74] 0 0
United Kingdom
State/province [74] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


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/NCT02075840