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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03178552




Registration number
NCT03178552
Ethics application status
Date submitted
5/06/2017
Date registered
7/06/2017

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC)
Scientific title
A Phase II/III Multicenter Study Evaluating the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring Actionable Somatic Mutations Detected in Blood (B-FAST: Blood-First Assay Screening Trial)
Secondary ID [1] 0 0
2017-000076-28
Secondary ID [2] 0 0
BO29554
Universal Trial Number (UTN)
Trial acronym
B-FAST
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 - Atezolizumab
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Cisplatin
Treatment: Drugs - Carboplatin
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Entrectinib
Treatment: Drugs - Cobimetinib
Treatment: Drugs - Vemurafenib
Treatment: Drugs - Bevacizumab
Treatment: Drugs - Divarasib
Treatment: Drugs - Docetaxel

Experimental: Cohort A: Alectinib 600 Milligrams (mg) - This cohort includes participants with anaplastic lymphoma kinase (ALK) positive NSCLC. Participants will receive alectinib 600 mg orally twice in a day (BID) until disease progression, unacceptable toxicity, withdrawal of consent or death.

Enrollment to Cohort A is complete.

Experimental: Cohort B: Dose Finding Phase (DFP) Alectinib - This cohort includes participants with rearranged during transfection (RET) positive NSCLC. Participants may receive alectinib 900 or 1200 mg orally BID until disease progression, unacceptable toxicity, withdrawal of consent or death if the recommended phase 2 dose (RP2D) is not established in any other clinical study. Participants may receive 750 mg or 600 mg, if it is unsafe to pursue the higher starting dose.

Enrollment to Cohort B is complete.

Experimental: Cohort B: Dose Expansion Phase (DEP) Alectinib - This cohort includes participants with RET positive NSCLC. Participants will receive alectinib at the RP2D established in the DFP of Cohort B or a separate clinical study. Participants will continue receiving study treatment until disease progression, unacceptable toxicity, withdrawal of consent or death.

Enrollment to Cohort B is complete.

Experimental: Cohort C: Atezolizumab 1200 mg - This cohort includes participants with bTMB positive NSCLC. Participants will receive atezolizumab at a dose of 1200 mg administered by IV infusion every 21 days (Q21D) until disease progression, loss of clinical benefit, unacceptable toxicity, withdrawal of consent or death.

Enrollment to Cohort C is complete.

Active comparator: Cohort C: Pemetrexed, Cisplatin or Carboplatin - This cohort includes participants with bTMB positive, non-squamous NSCLC. Participants will receive 4 or 6 cycles of treatment, with each cycle being 21 days in duration. Carboplatin at a dose of area under the concentration-time curve (AUC) of 5 or 6 IV or cisplatin at a dose of 75 milligrams per meter square (mg/m\^2) IV on Day 1 of each cycle combined with pemetrexed at a dose of 500 mg/m\^2 IV on Day 1 of each cycle. Pemetrexed may be continued as maintenance therapy every 21 days (Q21D) as per local standard of care.

Enrollment to Cohort C is complete.

Active comparator: Cohort C: Gemcitabine, Cisplatin or Carboplatin - This cohort includes participants with bTMB positive, squamous NSCLC. Participants will receive 4 or 6 cycles of treatment, with each cycle being 21 days in duration. Gemcitabine 1250 mg/m\^2 IV on Days 1 and 8 of every cycle and cisplatin 75 mg/m\^2 IV on Day 1 Q21D or gemcitabine 1000 mg/m\^2 IV on Days 1 and 8 of every cycle and carboplatin AUC 5 IV on Day 1 Q21D.

Enrollment to Cohort C is complete.

Experimental: Cohort D: Entrectinib 600 Milligrams (mg) - This cohort includes participants with c-ros oncogene 1 positive (ROS1+) NSCLC. Participants will receive entrectinib 600 mg orally once a day (QD) until disease progression, unacceptable toxicity, withdrawal of consent or death.

Enrollment to Cohort D is complete.

Experimental: Cohort E: Atezolizumab, Vemurafenib, and Cobimetinib - This cohort includes participants with BRAF V600 mutation. Participants will receive: atezolizumab 1680 mg IV Q4W after the run-in period; cobimetinib 60 mg orally (PO) QD on Days 1-21 of each cycle during the run-in and triple-combination periods; and vemurafenib 960 mg PO twice daily (BID) on Days 1-21 of the initial run-in period, then 720 mg PO BID on Days 1-22 of the initial run-in period and on Days 1-28 of each cycle during the triple-combination period.

Enrollment to Cohort E is complete.

Experimental: Cohort F: Atezolizumab, Bevacizumab, Carboplatin, and Pemetrexed - This cohort includes participants with EGFR exon 20+ NSCLC. Participants will receive atezolizumab + bevacizumab + carboplatin + pemetrexed for 4 or 6 induction cycles (cycle = 21 days). After induction therapy, participants will continue maintenance treatment with atezolizumab + bevacizumab + pemetrexed until disease progression, unacceptable toxicity, withdrawal of consent, or death.

Enrollment to Cohort F is complete.

Experimental: Cohort G: Divarasib or Docetaxel - Experimental: Cohort G: GDC-6036 or Docetaxel This cohort includes participants with KRAS G12C mutation. Participants will receive GDC-6036 PO QD or IV docetaxel Q3W (75 mg/m\^2) until disease progression or unacceptable toxicity

New participants will no longer receive docetaxel.

No intervention: Cohort Z: Natural History Cohort - Participants with genomic profiles of interest that are not enrolled in the other cohorts will enter into natural history follow-up.


Treatment: Drugs: Alectinib
Participants will receive 600 mg BID (Cohort A); 900, 1200, or 750 mg BID (Cohort B) or RP2D BID; orally until disease progression, unacceptable toxicity, withdrawal of consent or death.

Treatment: Drugs: Atezolizumab
Participants will receive atezolizumab 1200 mg IV infusion Q21D (Cohorts C and F) or 1680 mg IV infusion Q4W starting on Day 29 (Cohort E).

Treatment: Drugs: Pemetrexed
Participants will receive pemetrexed 500 mg/m\^2 IV infusion on Day 1 Q21D.

Treatment: Drugs: Cisplatin
Participants will receive cisplatin 75 mg/m\^2 IV on Day 1 Q21D.

Treatment: Drugs: Carboplatin
Participants will receive carboplatin of AUC 5 or 6 IV on Day 1 Q21D.

Treatment: Drugs: Gemcitabine
Participants will receive gemcitabine 1000 or 1250 mg/m\^2 on Days 1 and 8 of every cycle (1 Cycle=21 days).

Treatment: Drugs: Entrectinib
Participants will receive entrectinib 600 mg orally QD.

Treatment: Drugs: Cobimetinib
Participants will receive 60 mg PO QD on Days 1-21 of the initial run-in and triple-combination periods.

Treatment: Drugs: Vemurafenib
Participants will receive 960 mg PO BID on Days 1-21 of the initial run-in period, and 720 mg PO BID on Days 22-28 of the initial run-in period and on Days 1-28 of each cycle during the triple-combination period.

Treatment: Drugs: Bevacizumab
Participants will receive 15 mg/kg of IV bevacizumab on Day 1 of each 21-day cycle during the induction and maintenance periods.

Treatment: Drugs: Divarasib
Participants will receive divarasib PO QD until disease progression or unacceptable toxicity.

Treatment: Drugs: Docetaxel
Participants will receive IV docetaxel Q3W (75 mg/m\^2) until disease progression or unacceptable toxicity
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cohort A: Percentage of Participants with Confirmed Objective Response as Assessed by the Investigator Based on the Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
Timepoint [1] 0 0
Baseline up to disease progression or death (up to approximately 6 years)
Primary outcome [2] 0 0
Cohort B: Percentage of Participants with Confirmed Objective Response as Assessed by the Investigator Based on RECIST v1.1
Timepoint [2] 0 0
Baseline up to disease progression or death (up to approximately 6 years)
Primary outcome [3] 0 0
Cohort C: Progression Free Survival (PFS) as Assessed by the Investigator Based on RECIST v1.1 in bTMB PP1
Timepoint [3] 0 0
Baseline up to disease progression or death (up to approximately 6 years)
Primary outcome [4] 0 0
Cohort D: Percentage of Participants with Confirmed Objective Response as Assessed by the Investigator Based on RECIST v1.1
Timepoint [4] 0 0
Baseline up to disease progression or death (up to approximately 6 years)
Primary outcome [5] 0 0
Cohort E: Time in Response (TIR) as Assessed by the Investigator Based on RECIST v1.1
Timepoint [5] 0 0
Month 12
Primary outcome [6] 0 0
Cohort F: Investigator-Assessed Objective Response Rate (ORR) Based on RECIST v1.1
Timepoint [6] 0 0
Baseline up to disease progression or death (up to approximately 6 years)
Primary outcome [7] 0 0
Cohort G: Incidence of Adverse Events (AEs)
Timepoint [7] 0 0
Baseline to last dose of study treatment + 30 days or until initiation of new anticancer therapy, whichever occurs first (up to approximately 6 years)
Secondary outcome [1] 0 0
Cohorts A-F: Duration of Response (DOR) as Assessed by the Investigator Based on RECIST v1.1
Timepoint [1] 0 0
Baseline up to disease progression or death (up to approximately 6 years)
Secondary outcome [2] 0 0
Cohorts A, B and D: Percentage of Participants with Clinical Benefit Response as Assessed by the Investigator Based on RECIST v1.1
Timepoint [2] 0 0
Baseline up to disease progression or death (up to approximately 6 years)
Secondary outcome [3] 0 0
Cohorts A, B, D, F: PFS as Assessed by the Investigator Based on RECIST v1.1
Timepoint [3] 0 0
Baseline up to disease progression or death (up to approximately 6 years)
Secondary outcome [4] 0 0
Cohorts A-F: Duration of Response as Assessed by the Independent Review Facility (IRF) Based on RECIST v1.1
Timepoint [4] 0 0
Baseline up to disease progression or death (up to approximately 6 years)
Secondary outcome [5] 0 0
Cohorts A, B and D: Percentage of Participants with Clinical Benefit Response as Assessed by IRF Based on RECIST v1.1
Timepoint [5] 0 0
Baseline up to disease progression or death (up to approximately 6 years)
Secondary outcome [6] 0 0
Cohorts A-F: PFS as Assessed by IRF Based on RECIST v1.1
Timepoint [6] 0 0
Baseline up to disease progression or death (up to approximately 6 years)
Secondary outcome [7] 0 0
Cohorts A-F: Percentage of Participants with Confirmed Objective Response as Assessed by IRF Based on RECIST v1.1
Timepoint [7] 0 0
Baseline up to disease progression or death (up to approximately 6 years)
Secondary outcome [8] 0 0
Cohorts A-F: Overall Survival (OS)
Timepoint [8] 0 0
Baseline up to approximately 6 years
Secondary outcome [9] 0 0
Cohorts A-F: Percentage of Participants with Adverse Events (AEs)
Timepoint [9] 0 0
Baseline up to approximately 6 years
Secondary outcome [10] 0 0
Cohorts A, B, D, E, F: Percentage of Participants with Improvement Compared with Baseline in Total Severity Symptom Score as Measured by Symptoms in Lung Cancer (SILC) Scale in Patient-Reported Lung Cancer Symptoms (Cough, Dyspnea and Chest Pain)
Timepoint [10] 0 0
Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years
Secondary outcome [11] 0 0
Cohorts A-F: Time to Deterioration in Patient-Reported Lung Cancer Symptoms (Cough, Dyspnea and Chest Pain) as Measured by the SILC Scale
Timepoint [11] 0 0
Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years
Secondary outcome [12] 0 0
Cohorts C, E, F: Change from Baseline in Patient-Reported Lung Cancer Symptom (Cough, Dyspnea, Chest pain) Score as Measured by the SILC Scale
Timepoint [12] 0 0
Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years
Secondary outcome [13] 0 0
Cohorts A-F: Change from Baseline in Health Related Quality of Life (HRQoL) Scores as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - C30 (EORTC QLQ-C30)
Timepoint [13] 0 0
Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years
Secondary outcome [14] 0 0
Cohorts A, B, D, E, F: Change from Baseline in HRQoL Scores as Measured by the SILC Scale
Timepoint [14] 0 0
Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years
Secondary outcome [15] 0 0
Cohorts A-F: Change from Baseline in Patient Functioning and Symptoms Score as Measured by the EORTC QLQ-C30
Timepoint [15] 0 0
Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years
Secondary outcome [16] 0 0
Cohorts A, B, D, E, F: Change from Baseline in Patient Functioning and Symptoms Score as Measured by the SILC Scale
Timepoint [16] 0 0
Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years
Secondary outcome [17] 0 0
Cohorts A-F: Health Status Assessed as an Index Score Using the European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire
Timepoint [17] 0 0
Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years
Secondary outcome [18] 0 0
Cohort B: Percentage of Participants with Dose-Limiting Toxicities (DLTs)
Timepoint [18] 0 0
Day 1 to Day 28 of Cycle 1 (cycle length = 28 days)
Secondary outcome [19] 0 0
Cohort B: Maximum Plasma Concentration (Cmax) of Alectinib
Timepoint [19] 0 0
DFP: pre-dose (0 hours [hr]) on Day 1 of Cycle 2; 0.5, 1, 2, 4, 6, 8 and 10 hr post-dose on Day 1 of Cycle 2 (1 Cycle=28 days)
Secondary outcome [20] 0 0
Cohort B: Area Under the Concentration-Time Curve from Time Zero to the Last Measurable Concentration (AUC0-last) of Alectinib
Timepoint [20] 0 0
DFP: pre-dose (0 hr) on Day 1 of Cycle 2; 0.5, 1, 2, 4, 6, 8 and 10 hr post-dose on Day 1 of Cycle 2 (1 Cycle=28 days)
Secondary outcome [21] 0 0
Cohort B: Time to Reach Cmax (Tmax) of Alectinib
Timepoint [21] 0 0
DFP: pre-dose (0 hr) on Day 1 of Cycle 2; 0.5, 1, 2, 4, 6, 8 and 10 hr post-dose on Day 1 of Cycle 2 (1 Cycle=28 days)
Secondary outcome [22] 0 0
Cohort B: Half-Life (t1/2) of Alectinib
Timepoint [22] 0 0
DFP: pre-dose (0 hr) on Day 1 of Cycle 2; 0.5, 1, 2, 4, 6, 8 and 10 hr post-dose on Day 1 of Cycle 2 (1 Cycle=28 days)
Secondary outcome [23] 0 0
Cohort B: Metabolite to Parent Exposure Ratio for AUC0-last
Timepoint [23] 0 0
DFP: pre-dose (0 hr) on Day 1 of Cycle 2; 0.5, 1, 2, 4, 6, 8 and 10 hr post-dose on Day 1 of Cycle 2 (1 Cycle=28 days)
Secondary outcome [24] 0 0
Cohort B: Metabolite to Parent Exposure Ratio for Cmax
Timepoint [24] 0 0
DFP: pre-dose (0 hr) on Day 1 of Cycle 2; 0.5, 1, 2, 4, 6, 8 and 10 hr post-dose on Day 1 of Cycle 2 (1 Cycle=28 days)
Secondary outcome [25] 0 0
Cohort C: Percentage of Participants with Objective Response as Assessed by the Investigator Based on RECIST v1.1
Timepoint [25] 0 0
Baseline up to disease progression or death (up to approximately 6 years)
Secondary outcome [26] 0 0
Cohort C: Percentage of Participants Free from Disease Progression as Assessed by the Investigator Based on RECIST v1.1 at Months 6 and 12
Timepoint [26] 0 0
Months 6, 12
Secondary outcome [27] 0 0
Cohort C: PFS as Assessed by the Investigator based on RECIST v1.1 in bTMB PP2
Timepoint [27] 0 0
Baseline up to disease progression or death (up to approximately 6 years)
Secondary outcome [28] 0 0
Cohort C: OS in bTMB PP2
Timepoint [28] 0 0
Baseline up to approximately 6 years
Secondary outcome [29] 0 0
Cohort D: Time to CNS progression as Assessed by the Investigator Based on RECIST v1.1
Timepoint [29] 0 0
Baseline up to CNS progression (up to approximately 6 years)
Secondary outcome [30] 0 0
Cohort D: Time to CNS progression as Assessed by the IRF Based on RECIST v1.1
Timepoint [30] 0 0
Baseline up to CNS progression (up to approximately 6 years)
Secondary outcome [31] 0 0
Cohort D: Percentage of Participants who have shown improvement compared with Baseline in patient-reported cognitive function, fatigue, HRQoL, headache and vision disorder per the EORTC QLQ-C30
Timepoint [31] 0 0
Baseline, every 4 weeks until disease progression, up to approximately 6 years
Secondary outcome [32] 0 0
Cohort D: Percentage of Participants who have shown improvement compared with Baseline in patient-reported cognitive function, fatigue, HRQoL, headache and vision disorder per the EORTC QLQ-BN20
Timepoint [32] 0 0
Baseline, every 4 weeks until disease progression, up to approximately 6 years
Secondary outcome [33] 0 0
Cohort D: Mean Plasma Concentration of Entrectinib
Timepoint [33] 0 0
Pre-dose (0 hr), 1.5 and 4 hr post-dose on Day 1 of Cycles 1, 2, 3, 4 and 5; and pre-dose on Day 1 of each subsequent treatment cycle (1 cycle = 28 days).
Secondary outcome [34] 0 0
Cohort D: Mean Plasma Concentration of Entrectinib Metabolite M5
Timepoint [34] 0 0
Pre-dose (0 hr), 1.5 and 4 hr post-dose on Day 1 of Cycles 1, 2, 3, 4 and 5; and pre-dose on Day 1 of each subsequent treatment cycle (1 cycle = 28 days).
Secondary outcome [35] 0 0
Cohort E: TIR as Assessed by the Investigator Based on RECIST v1.1
Timepoint [35] 0 0
Month 9
Secondary outcome [36] 0 0
Cohort E: TIR as Assessed by IRF
Timepoint [36] 0 0
Month 12
Secondary outcome [37] 0 0
Cohorts E, F: Serum Concentration of Atezolizumab
Timepoint [37] 0 0
Pre-dose (0 hr), 1.5 and 4 hr post-dose on Day 1 of Cycles 1, 2, 3, 4 and 5; and pre-dose on Day 1 of each subsequent treatment cycle (1 cycle = 28 days)
Secondary outcome [38] 0 0
Cohorts E, F: Change from Baseline in Anti-Drug Antibodies (ADAs)
Timepoint [38] 0 0
Baseline up to approximately 6 years
Secondary outcome [39] 0 0
Cohorts E, F: Time to Confirmed Deterioration (TTCD) in Participant-Reported Lung Cancer Symptoms of Cough, Dyspnea, and Chest Pain, as Measured by the Symptoms in Lung Cancer (SILC)
Timepoint [39] 0 0
Baseline up to approximately 6 years
Secondary outcome [40] 0 0
Cohorts E, F: Proportion of Participants who Improve Compared with Baseline in Participant-Reported Lung Cancer Symptoms of Cough, Dyspnea, and Chest Pain, as Measured by the SILC
Timepoint [40] 0 0
Baseline up to approximately 6 years
Secondary outcome [41] 0 0
Cohort G: Plasma Concentration of Divarasib
Timepoint [41] 0 0
Baseline up to approximately 6 years

Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed diagnosis of unresectable Stage IIIb not amenable to treatment with combined modality chemoradiation (advanced) or Stage IV (metastatic) NSCLC
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
* Measurable disease
* Adequate recovery from most recent systemic or local treatment for cancer
* Adequate organ function
* Life expectancy greater than or equal to (>/=) 12 weeks
* For female participants of childbearing potential and male participants, willingness to use acceptable methods of contraception
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Inability to swallow oral medication
* Women who are pregnant or lactating
* Symptomatic, untreated CNS metastases
* History of malignancy other than NSCLC within 5 years prior to screening with the exception of malignancies with negligible risk of metastasis or death
* Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction, or cerebrovascular accident within 3 months prior to randomization, unstable arrhythmias, or unstable angina
* Known active or uncontrolled human immunodeficiency virus (HIV) infection
* Either a concurrent condition or history of a prior condition that places the patient at unacceptable risk if he/she were treated with the study drug or confounds the ability to interpret data from the study
* Inability to comply with other requirements of the protocol

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 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/09/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
3/08/2028
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal North Shore Hospital; Department of Medical Oncology - St Leonards
Recruitment hospital [2] 0 0
The Prince Charles Hospital; Oncology Dept. - Chermside
Recruitment hospital [3] 0 0
Ashford Cancer Center Research - Kurralta Park
Recruitment hospital [4] 0 0
Austin Hospital; Medical Oncology - Heidelberg
Recruitment hospital [5] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
4032 - Chermside
Recruitment postcode(s) [3] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
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
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Nevada
Country [10] 0 0
United States of America
State/province [10] 0 0
New Hampshire
Country [11] 0 0
United States of America
State/province [11] 0 0
New Jersey
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oregon
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
United States of America
State/province [19] 0 0
Washington
Country [20] 0 0
Algeria
State/province [20] 0 0
Algiers
Country [21] 0 0
Algeria
State/province [21] 0 0
Blida
Country [22] 0 0
Algeria
State/province [22] 0 0
Oran
Country [23] 0 0
Argentina
State/province [23] 0 0
Buenos Aires
Country [24] 0 0
Argentina
State/province [24] 0 0
Ciudad Autonoma Buenos Aires
Country [25] 0 0
Argentina
State/province [25] 0 0
La Rioja
Country [26] 0 0
Belgium
State/province [26] 0 0
Brussel
Country [27] 0 0
Belgium
State/province [27] 0 0
Bruxelles
Country [28] 0 0
Belgium
State/province [28] 0 0
Leuven
Country [29] 0 0
Brazil
State/province [29] 0 0
RJ
Country [30] 0 0
Brazil
State/province [30] 0 0
RS
Country [31] 0 0
Brazil
State/province [31] 0 0
SP
Country [32] 0 0
Canada
State/province [32] 0 0
Alberta
Country [33] 0 0
Canada
State/province [33] 0 0
Manitoba
Country [34] 0 0
Canada
State/province [34] 0 0
Ontario
Country [35] 0 0
Canada
State/province [35] 0 0
Quebec
Country [36] 0 0
Canada
State/province [36] 0 0
Saskatchewan
Country [37] 0 0
Chile
State/province [37] 0 0
Concepción
Country [38] 0 0
Chile
State/province [38] 0 0
Recoleta
Country [39] 0 0
China
State/province [39] 0 0
Beijing
Country [40] 0 0
China
State/province [40] 0 0
Changchun
Country [41] 0 0
China
State/province [41] 0 0
Changsha CITY
Country [42] 0 0
China
State/province [42] 0 0
Changsha City
Country [43] 0 0
China
State/province [43] 0 0
Chengdu City
Country [44] 0 0
China
State/province [44] 0 0
Guangzhou
Country [45] 0 0
China
State/province [45] 0 0
Hangzhou City
Country [46] 0 0
China
State/province [46] 0 0
Harbin
Country [47] 0 0
China
State/province [47] 0 0
Jinan
Country [48] 0 0
China
State/province [48] 0 0
Nanchang
Country [49] 0 0
China
State/province [49] 0 0
Nanjing City
Country [50] 0 0
China
State/province [50] 0 0
Shanghai
Country [51] 0 0
China
State/province [51] 0 0
Wuhan
Country [52] 0 0
China
State/province [52] 0 0
Xi'an
Country [53] 0 0
China
State/province [53] 0 0
Zhengzhou
Country [54] 0 0
Costa Rica
State/province [54] 0 0
San José
Country [55] 0 0
France
State/province [55] 0 0
Bordeaux
Country [56] 0 0
France
State/province [56] 0 0
Caen
Country [57] 0 0
France
State/province [57] 0 0
Lille
Country [58] 0 0
France
State/province [58] 0 0
Lyon
Country [59] 0 0
France
State/province [59] 0 0
Nimes
Country [60] 0 0
France
State/province [60] 0 0
Paris
Country [61] 0 0
France
State/province [61] 0 0
Poitiers
Country [62] 0 0
France
State/province [62] 0 0
Rennes
Country [63] 0 0
France
State/province [63] 0 0
Toulouse cedex 9
Country [64] 0 0
France
State/province [64] 0 0
Tours
Country [65] 0 0
France
State/province [65] 0 0
Vantoux
Country [66] 0 0
Germany
State/province [66] 0 0
Chemnitz
Country [67] 0 0
Germany
State/province [67] 0 0
Düsseldorf
Country [68] 0 0
Germany
State/province [68] 0 0
Essen
Country [69] 0 0
Germany
State/province [69] 0 0
Esslingen
Country [70] 0 0
Germany
State/province [70] 0 0
Gauting
Country [71] 0 0
Germany
State/province [71] 0 0
Gerlingen
Country [72] 0 0
Germany
State/province [72] 0 0
Heidelberg
Country [73] 0 0
Germany
State/province [73] 0 0
Wiesbaden
Country [74] 0 0
Hong Kong
State/province [74] 0 0
Hong Kong
Country [75] 0 0
Hong Kong
State/province [75] 0 0
Shatin
Country [76] 0 0
Israel
State/province [76] 0 0
Beer Sheva
Country [77] 0 0
Israel
State/province [77] 0 0
Haifa
Country [78] 0 0
Israel
State/province [78] 0 0
Kfar-Saba
Country [79] 0 0
Israel
State/province [79] 0 0
Petach Tikva
Country [80] 0 0
Israel
State/province [80] 0 0
Ramat Gan
Country [81] 0 0
Israel
State/province [81] 0 0
Tel Aviv
Country [82] 0 0
Italy
State/province [82] 0 0
Campania
Country [83] 0 0
Italy
State/province [83] 0 0
Emilia-Romagna
Country [84] 0 0
Italy
State/province [84] 0 0
Friuli-Venezia Giulia
Country [85] 0 0
Italy
State/province [85] 0 0
Lazio
Country [86] 0 0
Italy
State/province [86] 0 0
Lombardia
Country [87] 0 0
Italy
State/province [87] 0 0
Piemonte
Country [88] 0 0
Japan
State/province [88] 0 0
Aichi
Country [89] 0 0
Japan
State/province [89] 0 0
Chiba
Country [90] 0 0
Japan
State/province [90] 0 0
Ehime
Country [91] 0 0
Japan
State/province [91] 0 0
Fukuoka
Country [92] 0 0
Japan
State/province [92] 0 0
Hiroshima
Country [93] 0 0
Japan
State/province [93] 0 0
Ishikawa
Country [94] 0 0
Japan
State/province [94] 0 0
Kanagawa
Country [95] 0 0
Japan
State/province [95] 0 0
Kyoto
Country [96] 0 0
Japan
State/province [96] 0 0
Miyagi
Country [97] 0 0
Japan
State/province [97] 0 0
Niigata
Country [98] 0 0
Japan
State/province [98] 0 0
Okayama
Country [99] 0 0
Japan
State/province [99] 0 0
Osaka
Country [100] 0 0
Japan
State/province [100] 0 0
Saga
Country [101] 0 0
Japan
State/province [101] 0 0
Shizuoka
Country [102] 0 0
Japan
State/province [102] 0 0
Tokyo
Country [103] 0 0
Japan
State/province [103] 0 0
Wakayama
Country [104] 0 0
Japan
State/province [104] 0 0
Yamaguchi
Country [105] 0 0
Kenya
State/province [105] 0 0
Nairobi
Country [106] 0 0
Korea, Republic of
State/province [106] 0 0
Goyang-si
Country [107] 0 0
Korea, Republic of
State/province [107] 0 0
Jeollanam-do
Country [108] 0 0
Korea, Republic of
State/province [108] 0 0
Seoul
Country [109] 0 0
Mexico
State/province [109] 0 0
BAJA California
Country [110] 0 0
Mexico
State/province [110] 0 0
Mexico CITY (federal District)
Country [111] 0 0
Mexico
State/province [111] 0 0
Nuevo LEON
Country [112] 0 0
Mexico
State/province [112] 0 0
SAN LUIS Potosi
Country [113] 0 0
Netherlands
State/province [113] 0 0
NL -groningen
Country [114] 0 0
Netherlands
State/province [114] 0 0
Rotterdam
Country [115] 0 0
New Zealand
State/province [115] 0 0
Auckland
Country [116] 0 0
Panama
State/province [116] 0 0
Panama City
Country [117] 0 0
Peru
State/province [117] 0 0
Lima
Country [118] 0 0
Peru
State/province [118] 0 0
San Isidro
Country [119] 0 0
Poland
State/province [119] 0 0
Gdansk
Country [120] 0 0
Poland
State/province [120] 0 0
Krakow
Country [121] 0 0
Poland
State/province [121] 0 0
Olsztyn
Country [122] 0 0
Poland
State/province [122] 0 0
Otwock
Country [123] 0 0
Poland
State/province [123] 0 0
Poznan
Country [124] 0 0
Poland
State/province [124] 0 0
Warszawa
Country [125] 0 0
Russian Federation
State/province [125] 0 0
Moskovskaja Oblast
Country [126] 0 0
Russian Federation
State/province [126] 0 0
Sankt Petersburg
Country [127] 0 0
Russian Federation
State/province [127] 0 0
Omsk
Country [128] 0 0
Serbia
State/province [128] 0 0
Belgrade
Country [129] 0 0
Serbia
State/province [129] 0 0
NIS
Country [130] 0 0
Serbia
State/province [130] 0 0
Sremska Kamenica
Country [131] 0 0
Singapore
State/province [131] 0 0
Singapore
Country [132] 0 0
Spain
State/province [132] 0 0
Barcelona
Country [133] 0 0
Spain
State/province [133] 0 0
LA Coruña
Country [134] 0 0
Spain
State/province [134] 0 0
Madrid
Country [135] 0 0
Spain
State/province [135] 0 0
Navarra
Country [136] 0 0
Spain
State/province [136] 0 0
Alicante
Country [137] 0 0
Spain
State/province [137] 0 0
Malaga
Country [138] 0 0
Spain
State/province [138] 0 0
Sevilla
Country [139] 0 0
Spain
State/province [139] 0 0
Valencia
Country [140] 0 0
Taiwan
State/province [140] 0 0
Kaohsiung
Country [141] 0 0
Taiwan
State/province [141] 0 0
Taipei
Country [142] 0 0
Taiwan
State/province [142] 0 0
Taoyuan
Country [143] 0 0
Thailand
State/province [143] 0 0
Bangkok
Country [144] 0 0
Thailand
State/province [144] 0 0
Hat Yai
Country [145] 0 0
Turkey
State/province [145] 0 0
Adana
Country [146] 0 0
Turkey
State/province [146] 0 0
Ankara
Country [147] 0 0
Turkey
State/province [147] 0 0
Antalya
Country [148] 0 0
Turkey
State/province [148] 0 0
Edirne
Country [149] 0 0
Turkey
State/province [149] 0 0
Istanbul
Country [150] 0 0
Turkey
State/province [150] 0 0
Kar??yaka
Country [151] 0 0
Turkey
State/province [151] 0 0
Sihhiye/Ankara

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
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
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: BO29554 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. and Canada)
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


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 not provided in https://clinicaltrials.gov/study/NCT03178552