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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02460224




Registration number
NCT02460224
Ethics application status
Date submitted
9/05/2015
Date registered
2/06/2015

Titles & IDs
Public title
Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies.
Scientific title
A Phase I/II, Open Label, Multicenter Study of the Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 Administered to Patients With Advanced Malignancies
Secondary ID [1] 0 0
2015-000449-21
Secondary ID [2] 0 0
CLAG525X2101C
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LAG525
Treatment: Drugs - PDR001

Experimental: Phase 1: LAG525 1 mg/kg Q2W - Single-agent LAG525 1 mg/kg Q2W

Experimental: Phase 1: LAG525 3 mg/kg Q2W - Single-agent LAG525 3 mg/kg Q2W

Experimental: Phase 1: LAG525 5 mg/kg Q2W - Single-agent LAG525 5 mg/kg Q2W

Experimental: Phase 1: LAG525 10 mg/kg Q2W - Single-agent LAG525 10 mg/kg Q2W

Experimental: Phase 1: LAG525 15 mg/kg Q2W - Single-agent LAG525 15 mg/kg Q2W

Experimental: Phase 1: LAG525 240 mg Q2W - Single-agent LAG525 240 mg Q2W

Experimental: Phase 1: LAG525 400 mg Q2W - Single-agent LAG525 400 mg Q2W

Experimental: Phase 1: LAG525 3 mg/kg Q4W - Single-agent LAG525 3 mg/kg Q4W

Experimental: Phase 1: LAG525 5 mg/kg Q4W - Single-agent LAG525 5 mg/kg Q4W

Experimental: Phase 1: LAG525 10 mg/kg Q4W - Single-agent LAG525 10 mg/kg Q4W

Experimental: Phase 1: LAG525 400 mg Q4W - Single-agent LAG525 400 mg Q4W

Experimental: Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W - Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)

Experimental: Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W - Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)

Experimental: Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W - Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)

Experimental: Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W - Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)

Experimental: Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W - Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)

Experimental: Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W - Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)

Experimental: Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W - Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)

Experimental: Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W - Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)

Experimental: Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W - Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)

Experimental: Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W - Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)

Experimental: Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W - Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)

Experimental: Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W - Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)

Experimental: Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W - Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)

Experimental: Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W - Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)

Experimental: Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W - Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)

Experimental: Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W - Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1

Experimental: Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W - Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1

Experimental: Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W - Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1


Treatment: Drugs: LAG525
LAG525 was administered via intravenous (i.v.) infusion

Treatment: Drugs: PDR001
PDR001 was administered via i.v. infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs)
Timepoint [1] 0 0
15 days for single-agent LAG525 arms and 30 days for the combination LAG525 + PDR001 arms
Primary outcome [2] 0 0
Phase 2: Overall Response Rate (ORR) Per RECIST 1.1
Timepoint [2] 0 0
From start of treatment until end of treatment, assessed up to 2.6 years
Secondary outcome [1] 0 0
Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [1] 0 0
From first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed up to 4.5 years.
Secondary outcome [2] 0 0
Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [2] 0 0
From first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed up to 2.7 years.
Secondary outcome [3] 0 0
Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
Timepoint [3] 0 0
From start of treatment until end of treatment, assessed up to 4.4 years.
Secondary outcome [4] 0 0
Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
Timepoint [4] 0 0
From start of treatment until end of treatment, assessed up to 2.6 years.
Secondary outcome [5] 0 0
Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001
Timepoint [5] 0 0
From start of treatment until end of treatment, assessed up to 4.4 years.
Secondary outcome [6] 0 0
Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001
Timepoint [6] 0 0
From start of treatment until end of treatment, assessed up to 2.6 years.
Secondary outcome [7] 0 0
Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525
Timepoint [7] 0 0
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
Secondary outcome [8] 0 0
Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525
Timepoint [8] 0 0
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
Secondary outcome [9] 0 0
Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525
Timepoint [9] 0 0
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
Secondary outcome [10] 0 0
Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525
Timepoint [10] 0 0
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
Secondary outcome [11] 0 0
Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525
Timepoint [11] 0 0
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
Secondary outcome [12] 0 0
Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525
Timepoint [12] 0 0
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
Secondary outcome [13] 0 0
Phase 1: Terminal Elimination Half-life (T1/2) of LAG525
Timepoint [13] 0 0
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
Secondary outcome [14] 0 0
Phase 2: Terminal Elimination Half-life (T1/2) of LAG525
Timepoint [14] 0 0
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
Secondary outcome [15] 0 0
Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001
Timepoint [15] 0 0
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
Secondary outcome [16] 0 0
Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001
Timepoint [16] 0 0
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
Secondary outcome [17] 0 0
Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001
Timepoint [17] 0 0
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
Secondary outcome [18] 0 0
Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001
Timepoint [18] 0 0
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
Secondary outcome [19] 0 0
Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001
Timepoint [19] 0 0
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
Secondary outcome [20] 0 0
Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001
Timepoint [20] 0 0
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
Secondary outcome [21] 0 0
Phase 1: Terminal Elimination Half-life (T1/2) of PDR001
Timepoint [21] 0 0
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
Secondary outcome [22] 0 0
Phase 2: Terminal Elimination Half-life (T1/2) of PDR001
Timepoint [22] 0 0
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
Secondary outcome [23] 0 0
Phase 1: Number of Participants With Anti-LAG525 Antibodies
Timepoint [23] 0 0
Baseline (pre-infusion on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 4.4 years).
Secondary outcome [24] 0 0
Phase 2: Number of Participants With Anti-LAG525 Antibodies
Timepoint [24] 0 0
Baseline (pre-infusion on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 2.6 years).
Secondary outcome [25] 0 0
Phase 1: Number of Participants With Anti-PDR001 Antibodies
Timepoint [25] 0 0
Baseline (pre-infusion on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 4.4 years).
Secondary outcome [26] 0 0
Phase 2: Number of Participants With Anti-PDR001 Antibodies
Timepoint [26] 0 0
Baseline (pre-infusion on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 2.6 years).
Secondary outcome [27] 0 0
Phase 1: Overall Response Rate (ORR) Per RECIST 1.1
Timepoint [27] 0 0
From start of treatment until end of treatment, assessed up to 4.4 years
Secondary outcome [28] 0 0
Phase 1: Overall Response Rate (ORR) Per irRC
Timepoint [28] 0 0
From start of treatment until end of treatment, assessed up to 4.4 years
Secondary outcome [29] 0 0
Phase 2: Overall Response Rate (ORR) Per irRC
Timepoint [29] 0 0
From start of treatment until end of treatment, assessed up to 2.6 years
Secondary outcome [30] 0 0
Phase 1: Disease Control Rate (DCR) Per RECIST 1.1
Timepoint [30] 0 0
From start of treatment until end of treatment, assessed up to 4.4 years
Secondary outcome [31] 0 0
Phase 1: Disease Control Rate (DCR) Per irRC
Timepoint [31] 0 0
From start of treatment until end of treatment, assessed up to 4.4 years
Secondary outcome [32] 0 0
Phase 2: Disease Control Rate (DCR) Per RECIST 1.1
Timepoint [32] 0 0
From start of treatment until end of treatment, assessed up to 2.6 years
Secondary outcome [33] 0 0
Phase 2: Disease Control Rate (DCR) Per irRC
Timepoint [33] 0 0
From start of treatment until end of treatment, assessed up to 2.6 years
Secondary outcome [34] 0 0
Phase 1: Duration of Response (DOR) Per RECIST 1.1
Timepoint [34] 0 0
From first documented response (CR or PR) to first documented progression or death due to study indication, assessed up to 4.4 years
Secondary outcome [35] 0 0
Phase 1: Duration of Response (DOR) Per irRC
Timepoint [35] 0 0
From first documented response (irCR or irPR) to first documented progression or death due to study indication, assessed up to 4.4 years
Secondary outcome [36] 0 0
Phase 2: Duration of Response (DOR) Per RECIST 1.1
Timepoint [36] 0 0
From first documented response (CR or PR) to first documented progression or death due to study indication, assessed up to 2.6 years
Secondary outcome [37] 0 0
Phase 2: Duration of Response (DOR) Per irRC
Timepoint [37] 0 0
From first documented response (irCR or irPR) to first documented progression or death due to study indication, assessed up to 2.6 years
Secondary outcome [38] 0 0
Phase 1: Progression-free Survival (PFS) Per RECIST 1.1
Timepoint [38] 0 0
From start of treatment to first documented progression or death due to any cause, assessed up to 4.4 years
Secondary outcome [39] 0 0
Phase 1: Progression-free Survival (PFS) Per irRC
Timepoint [39] 0 0
From start of treatment to first documented progression or death due to any cause, assessed up to 4.4 years
Secondary outcome [40] 0 0
Phase 2: Progression-free Survival (PFS) Per RECIST 1.1
Timepoint [40] 0 0
From start of treatment to first documented progression or death due to any cause, assessed up to 2.6 years
Secondary outcome [41] 0 0
Phase 2: Progression-free Survival (PFS) Per irRC
Timepoint [41] 0 0
From start of treatment to first documented progression or death due to any cause, assessed up to 2.6 years

Eligibility
Key inclusion criteria
Phase I part:

- Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by RECIST version 1.1, who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists

Phase II part:

* Patients with advanced/metastatic solid tumors, with at least one measurable lesion as determined by RECIST version 1.1, who have had disease progression following their last prior therapy and fit into one of the following groups:
* Group 1: NSCLC
* Group 2: Melanoma
* Group 3: Renal cancer
* Group 4: Mesothelioma
* Group 5: TNBC
* Eastern Cooperative Oncology Group (ECOG) Performance Status = 1
* Patient must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of severe hypersensitivity reactions to study treatment ingredients or other mAbs
* Active, known or suspected autoimmune disease
* Active infection requiring systemic antibiotic therapy
* HIV infection. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
* Patients receiving chronic treatment with systemic steroid therapy, other than replacement-dose corticosteroids in the setting of adrenal insufficiency
* Patients receiving systemic treatment with any immunosuppressive medication
* Use of live vaccines against infectious disease within 4 weeks of initiation of study treatment
* Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment.
* Presence of symptomatic central nervous system (CNS) metastases or CNS metastases that require local CNS-directed therapy or increasing doses of corticosteroids within the prior 2 weeks
* History of drug-induced pneumonitis or current pneumonitis.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
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
17/06/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/12/2020
Sample size
Target
Accrual to date
Final
490
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Westmead
Recruitment hospital [2] 0 0
Novartis Investigative Site - Heidelberg
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
United States of America
State/province [2] 0 0
North Carolina
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
United States of America
State/province [4] 0 0
Utah
Country [5] 0 0
Belgium
State/province [5] 0 0
Leuven
Country [6] 0 0
Canada
State/province [6] 0 0
Alberta
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
France
State/province [8] 0 0
Lyon Cedex
Country [9] 0 0
France
State/province [9] 0 0
Saint-Herblain Cédex
Country [10] 0 0
Germany
State/province [10] 0 0
Heidelberg
Country [11] 0 0
Germany
State/province [11] 0 0
Wuerzburg
Country [12] 0 0
Hong Kong
State/province [12] 0 0
Hong Kong
Country [13] 0 0
Italy
State/province [13] 0 0
MI
Country [14] 0 0
Italy
State/province [14] 0 0
MO
Country [15] 0 0
Japan
State/province [15] 0 0
Fukuoka
Country [16] 0 0
Singapore
State/province [16] 0 0
Singapore
Country [17] 0 0
Spain
State/province [17] 0 0
Catalunya
Country [18] 0 0
Spain
State/province [18] 0 0
Madrid
Country [19] 0 0
Taiwan
State/province [19] 0 0
Taipei

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

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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/NCT02460224