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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02545283




Registration number
NCT02545283
Ethics application status
Date submitted
31/08/2015
Date registered
9/09/2015
Date last updated
11/01/2022

Titles & IDs
Public title
A Study of Idasanutlin With Cytarabine Versus Cytarabine Plus Placebo in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)
Scientific title
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase III Study of Idasanutlin, an MDM2 Antagonist, With Cytarabine Versus Cytarabine Plus Placebo in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
Secondary ID [1] 0 0
2014-003065-15
Secondary ID [2] 0 0
WO29519
Universal Trial Number (UTN)
Trial acronym
MIRROS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia, Myeloid, Acute 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cytarabine
Treatment: Drugs - Idasanutlin
Other interventions - Placebo

Experimental: Idasanutlin plus Cytarabine - Participants will receive induction therapy idasanutlin and cytarabine for 5 Days followed by 23 days of rest in Cycle 1 (treatment cycle length=28 days). Responding participants may continue with consolidation therapy for a maximum of 2 additional cycles including idasanutlin and cytarabine for 5 days followed by 23 days of rest in each cycle (treatment cycle length=28 days). After each cycle, for participants achieving CRp or complete remission with incomplete blood count recovery (CRi), up to 28 additional days are allowed for blood count recovery, if needed.

Placebo comparator: Placebo plus Cytarabine - Participants will receive induction therapy idasanutlin matching placebo and cytarabine for 5 days followed by 23 days of rest in Cycle 1 (treatment cycle length=28 days). Responding participants may continue with consolidation therapy for a maximum of 2 additional cycles including idasanutlin matching placebo and cytarabine for 5 days followed by 23 days of rest in each cycle (treatment cycle length=28 days). After each cycle, for participants achieving CRp or CRi, up to 28 additional days are allowed for blood count recovery, if needed.


Treatment: Drugs: Cytarabine
Participants will receive cytarabine 1 gram per square meter (g/m\^2) intravenous (IV) infusion for 5 days of every treatment cycle.

Treatment: Drugs: Idasanutlin
Participants will receive idasanutlin 300 mg per oral (PO) twice daily (BID) (in Cycle 1) or once daily (QD) (in Cycles 2 and 3) for 5 days of every treatment cycle.

Other interventions: Placebo
Participants will receive idasanutlin matching placebo PO BID or QD for 5 days of every treatment cycle.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival in TP53 WT Population
Timepoint [1] 0 0
From randomization to death from any cause (up to approximately 4.5 years)
Secondary outcome [1] 0 0
Percentage of Participants in Complete Response (CR) at the End of Induction According to Hematologic Malignancy Response Assessment (HMRA) in TP53 WT Population
Timepoint [1] 0 0
At the end of induction (up to Day 56)
Secondary outcome [2] 0 0
Event-Free Survival (EFS) According to HMRA in TP53 WT Population
Timepoint [2] 0 0
From randomization up to treatment failure, relapse, or death from any cause (up to approximately 4.5 years)
Secondary outcome [3] 0 0
Percentage of Participants With Overall Remission (CR, CRp, and CRi) at the End of Induction According to HMRA in TP53 WT Population
Timepoint [3] 0 0
At the end of induction (up to Day 56)
Secondary outcome [4] 0 0
Duration of Remission Following CR (DOR) in TP53 WT Population
Timepoint [4] 0 0
From achieving CR until relapse or death from any cause (up to approximately 4.5 years)
Secondary outcome [5] 0 0
Percentage of Participants Undergoing HSCT Following Complete Response (CR), in TP53 WT Population
Timepoint [5] 0 0
Baseline up to approximately 4.5 years
Secondary outcome [6] 0 0
Percentage of Participants With Complete Response (CR) in Clinically Actionable Mutation-Defined Subpopulation (FLT3, IDH1 and IDH2) in TP53 WT Population
Timepoint [6] 0 0
At the end of induction (up to Day 56)
Secondary outcome [7] 0 0
Overall Survival in Clinically Actionable Mutation-Defined Subpopulation (FLT3, IDH1 and IDH2) in TP53 WT Population
Timepoint [7] 0 0
From randomization to death from any cause (up to approximately 4.5 years)
Secondary outcome [8] 0 0
Number of Participants Who Experienced at Least One Adverse Event by Severity, According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.03 (NCI-CTCAE v4.03)
Timepoint [8] 0 0
Baseline up to approximately 4.5 years
Secondary outcome [9] 0 0
Number of Participants With Adverse Events Leading to Discontinuation
Timepoint [9] 0 0
Baseline up to approximately 4.5 years
Secondary outcome [10] 0 0
Number of Participants With Adverse Events Leading to Death up to Day 30
Timepoint [10] 0 0
Up to Day 30
Secondary outcome [11] 0 0
Number of Participants With Adverse Events Leading to Death up to Day 60
Timepoint [11] 0 0
Up to Day 60
Secondary outcome [12] 0 0
Number of Participants With Clinical Laboratory Abnormalities in Biochemistry Tests at the Greatest Severity, According to NCI-CTCAE v4.03
Timepoint [12] 0 0
Up to Approximately 4.5 Years
Secondary outcome [13] 0 0
Number of Participants With Clinical Laboratory Abnormalities in Hematology Tests at the Greatest Severity, According to NCI-CTCAE v4.03
Timepoint [13] 0 0
Up to Approximately 4.5 Years
Secondary outcome [14] 0 0
Change From Baseline in Body Temperature Over Time
Timepoint [14] 0 0
Baseline; Cycles 1-3, Days 8, 15, 22, 28 (1 cycle is 28 days); and, if incomplete blood count recovery, Days 29-42 and Days 43-56, Cycles 2 -3 Days 1, 8, 15, 22, 28 and 29-56 (max delay between cycles is 56 days)
Secondary outcome [15] 0 0
Change From Baseline in Systolic Blood Pressure Over Time
Timepoint [15] 0 0
Baseline; Cycles 1-3, Days 8, 15, 22, 28 (1 cycle is 28 days); and, if incomplete blood count recovery, Days 29-42 and Days 43-56, Cycles 2 -3 Days 1, 8, 15, 22, 28 and 29-56 (max delay between cycles is 56 days)
Secondary outcome [16] 0 0
Change From Baseline in Diastolic Blood Pressure Over Time
Timepoint [16] 0 0
Baseline; Cycles 1-3, Days 8, 15, 22, 28 (1 cycle is 28 days); and, if incomplete blood count recovery, Days 29-42 and Days 43-56, Cycles 2 -3 Days 1, 8, 15, 22, 28 and 29-56 (max delay between cycles is 56 days)
Secondary outcome [17] 0 0
Change From Baseline in Pulse Rate Over Time
Timepoint [17] 0 0
Baseline; Cycles 1-3, Days 8, 15, 22, 28 (1 cycle is 28 days); and, if incomplete blood count recovery, Days 29-42 and Days 43-56, Cycles 2 -3 Days 1, 8, 15, 22, 28 and 29-56 (max delay between cycles is 56 days)
Secondary outcome [18] 0 0
Change From Baseline in Respiratory Rate Over Time
Timepoint [18] 0 0
Up to Approximately 4.5 Years
Secondary outcome [19] 0 0
Change From Baseline in Heart Rate, as Measured by Electrocardiogram
Timepoint [19] 0 0
Baseline; Cycles 1-3 Day 1 (2 hrs pre-dose, post-Cytarabine and 6 hrs post-Idasanutlin/Placebo ); Cycle 1-3 Day 2; Cycle 1 Day 5 (within 2 hrs Idanasanutlin/Placebo, post-Cytarabine and 6 hrs post-Idasanutlin/Placebo), Study Drug Completion
Secondary outcome [20] 0 0
Change From Baseline in Electrocardiogram Parameters: PQ, PR, RR, QRS, QT and QTcF Intervals
Timepoint [20] 0 0
Baseline, Days 1, 2, and 5 of Cycle 1, Days 1, 2 of Cycles 2 and 3 (1 cycle is 28 days), Treatment Discontinuation Visit (28 days after last dose of study drug)
Secondary outcome [21] 0 0
Total Duration of Study Treatment
Timepoint [21] 0 0
Up to 3 cycles (1 cycle is 28 days)
Secondary outcome [22] 0 0
Number of Treatment Cycles Started
Timepoint [22] 0 0
Up to 3 cycles (1 cycle is 28 days)
Secondary outcome [23] 0 0
Cumulative Dose of Idasanutlin and Cytarabine
Timepoint [23] 0 0
Up to 3 cycles (1 cycle is 28 days)
Secondary outcome [24] 0 0
Apparent Clearance (CL/F) of Idasanutlin
Timepoint [24] 0 0
Cycle 1: Predose (0 hour [Hr]), end of 1-3 Hr cytarabine infusion, 6 Hr postdose on Days 1, 5; Predose (0 Hr) on Day 2; at Days 8, 10; Cycle 2, 3: predose (0 Hr) on Days 2, 5 (predose/postdose: relative to idasanutlin morning dose; cycle length= 28 days)
Secondary outcome [25] 0 0
Apparent Volume of Distribution (Vd/F) of Idasanutlin
Timepoint [25] 0 0
Cycle 1: Predose (0 Hr), end of 1-3 Hr cytarabine infusion, 6 Hr postdose on Days 1, 5; Predose (0 Hr) on Day 2; at Days 8, 10; Cycle 2, 3: predose (0 Hr) on Days 2, 5 (predose/postdose: relative to idasanutlin morning dose; cycle length= 28 days)
Secondary outcome [26] 0 0
Maximum Concentration Observed (Cmax) of Idasanutlin
Timepoint [26] 0 0
Cycle 1: Predose (0 Hr), end of 1-3 Hr cytarabine infusion, 6 Hr postdose on Days 1, 5; Predose (0 Hr) on Day 2; at Days 8, 10; Cycle 2, 3: predose (0 Hr) on Days 2, 5 (predose/postdose: relative to idasanutlin morning dose; cycle length= 28 days)
Secondary outcome [27] 0 0
Steady-State Concentration (Ctrough) of Idasanutlin
Timepoint [27] 0 0
Cycle 1: Predose (0 Hr), end of 1-3 Hr cytarabine infusion, 6 Hr postdose on Days 1, 5; Predose (0 Hr) on Day 2; at Days 8, 10; Cycle 2, 3: predose (0 Hr) on Days 2, 5 (predose/postdose: relative to idasanutlin morning dose; cycle length= 28 days)
Secondary outcome [28] 0 0
Area Under the Concentration-Time Curve (AUC) During One Dosing Interval (AUCtau) of Idasanutlin
Timepoint [28] 0 0
Cycle 1: Predose (0 Hr), end of 1-3 Hr cytarabine infusion, 6 Hr postdose on Days 1, 5; Predose (0 Hr) on Day 2; at Days 8, 10; Cycle 2, 3: predose (0 Hr) on Days 2, 5 (predose/postdose: relative to idasanutlin morning dose; cycle length= 28 days)
Secondary outcome [29] 0 0
AUC From Time Zero to 24 Hours Post Dose (AUC0-24) of Idasanutlin
Timepoint [29] 0 0
Cycle 1: Predose (0 Hr), end of 1-3 Hr cytarabine infusion, 6 Hr postdose on Days 1, 5; Predose (0 Hr) on Day 2; at Days 8, 10; Cycle 2, 3: predose (0 Hr) on Days 2, 5 (predose/postdose: relative to idasanutlin morning dose; cycle length= 28 days)
Secondary outcome [30] 0 0
Half-Life (t 1/2) of Idasanutlin
Timepoint [30] 0 0
Cycle 1: Predose (0 Hr), end of 1-3 Hr cytarabine infusion, 6 Hr postdose on Days 1, 5; Predose (0 Hr) on Day 2; at Days 8, 10; Cycle 2, 3: predose (0 Hr) on Days 2, 5 (predose/postdose: relative to idasanutlin morning dose; cycle length= 28 days)
Secondary outcome [31] 0 0
Total Clearance (CL) of Cytarabine
Timepoint [31] 0 0
Cycle 1: Within 2 Hr pre-cytarabine dose, end of 1-3 Hr cytarabine infusion, 6 Hr post idasanutlin morning dose on Days 1, 5; Within 2 Hr pre-cytarabine dose on Day 2; Cycle 2, 3: Within 2 Hr pre-cytarabine dose on Day 2 (Cycle length= 28 days)
Secondary outcome [32] 0 0
Volume of Distribution (Vd) of Cytarabine
Timepoint [32] 0 0
Cycle 1: Within 2 Hr pre-cytarabine dose, end of 1-3 Hr cytarabine infusion, 6 Hr post idasanutlin morning dose on Days 1, 5; Within 2 Hr pre-cytarabine dose on Day 2; Cycle 2, 3: Within 2 Hr pre-cytarabine dose on Day 2 (Cycle length= 28 days)
Secondary outcome [33] 0 0
Change From Baseline in European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score
Timepoint [33] 0 0
Cycle 1 Day 1 (Baseline), Days 8, 15, 28 of Cycle 1, Days 1, 8, 15, 28 of Cycles 2, 3, 28 days after last dose (last dose on Cycle 3 Day 5), thereafter every 3 months until relapse (maximum up to 3.5 years)
Secondary outcome [34] 0 0
Change From Baseline in EuroQol 5 Dimension 5-Level (EQ-5D-5L) Questionnaire Score
Timepoint [34] 0 0
Cycle 1 Day 1 (Baseline), Days 8, 15, 28 of Cycle 1, Days 1, 8, 15, 28 of Cycles 2, 3, 28 days after last dose (last dose on Cycle 3 Day 5), thereafter every 3 months until relapse (maximum up to 3.5 years)

Eligibility
Key inclusion criteria
* Documented/confirmed first/second refractory/relapsed AML using World Health Organization classification, except acute promyelocytic leukemia
* No more than 2 prior induction regimens (excluding prior HSCT) in their first line treatment and one must have included cytarabine with an anthracycline (or anthracenedione)
* Eastern Cooperative Oncology Group performance status of 0 to 2
* Adequate hepatic and renal function
* White blood cell (WBC) count at randomization less than or equal to (</=) 50000 cells per cubic millimeter (/mm^3)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* First relapsed participants aged less than (<) 60 years with first CR duration greater than (>) 1 year
* Participants with prior documented antecedent hematological disorder (AHD)
* AML secondary to any prior chemotherapy unrelated to leukemia
* Participants who are either refractory to or relapsed within 90 days of receiving a regimen containing a cumulative dose of greater than or equal to (>/=) 18 g/m^2 of cytarabine
* Participants who have received allogeneic HSCT within 90 days prior to randomization
* Participants who have received immunosuppressive therapy for graft versus host disease or for engraftment syndrome after autologous stem cell transplantation within 2 weeks prior to randomization
* Prior treatment with an Murine Double Minute 2 (MDM2) antagonist
* Participants receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy within 30 days from first receipt of study drug
* Participants with a history of other malignancy within 5 years prior to screening except for malignancy that has been in remission without treatment for at least 2 years prior to randomization
* Participants who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
* Participants with extramedullary AML with no evidence of systemic involvement
* Pregnant or breastfeeding participants

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/12/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/04/2020
Sample size
Target
Accrual to date
Final
447
Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,VIC
Recruitment hospital [1] 0 0
Canberra Hospital; Haematology Department - Canberra
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital; Haematology - Sydney
Recruitment hospital [3] 0 0
Royal Adelaide Hospital; Haematology Clinical Trials - Adelaide
Recruitment hospital [4] 0 0
Geelong Hospital; Andrew Love Cancer Centre - Geelong
Recruitment hospital [5] 0 0
Alfred Hospital; Clinical Haematology and Bone Marrow Transplantation - Melbourne
Recruitment postcode(s) [1] 0 0
2605 - Canberra
Recruitment postcode(s) [2] 0 0
2139 - Sydney
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3220 - Geelong
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
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
Pennsylvania
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
Austria
State/province [4] 0 0
Graz
Country [5] 0 0
Belgium
State/province [5] 0 0
Haine-Saint-Paul
Country [6] 0 0
Belgium
State/province [6] 0 0
Liège
Country [7] 0 0
Belgium
State/province [7] 0 0
Roeselare
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
Finland
State/province [9] 0 0
Helsinki
Country [10] 0 0
Finland
State/province [10] 0 0
Tampere
Country [11] 0 0
France
State/province [11] 0 0
Angers Cedex 9
Country [12] 0 0
France
State/province [12] 0 0
Lille
Country [13] 0 0
France
State/province [13] 0 0
Marseille
Country [14] 0 0
France
State/province [14] 0 0
Nantes
Country [15] 0 0
France
State/province [15] 0 0
Paris
Country [16] 0 0
France
State/province [16] 0 0
Pessac
Country [17] 0 0
France
State/province [17] 0 0
Pierre Benite
Country [18] 0 0
France
State/province [18] 0 0
Toulouse
Country [19] 0 0
France
State/province [19] 0 0
Vandoeuvre Les Nancy
Country [20] 0 0
Germany
State/province [20] 0 0
Aachen
Country [21] 0 0
Germany
State/province [21] 0 0
Bonn
Country [22] 0 0
Germany
State/province [22] 0 0
Braunschweig
Country [23] 0 0
Germany
State/province [23] 0 0
Chemnitz
Country [24] 0 0
Germany
State/province [24] 0 0
Dresden
Country [25] 0 0
Germany
State/province [25] 0 0
Hannover
Country [26] 0 0
Germany
State/province [26] 0 0
Köln
Country [27] 0 0
Germany
State/province [27] 0 0
Mainz
Country [28] 0 0
Germany
State/province [28] 0 0
Marburg
Country [29] 0 0
Israel
State/province [29] 0 0
Jerusalem
Country [30] 0 0
Israel
State/province [30] 0 0
Petach Tikva
Country [31] 0 0
Israel
State/province [31] 0 0
Tel Aviv
Country [32] 0 0
Italy
State/province [32] 0 0
Campania
Country [33] 0 0
Italy
State/province [33] 0 0
Emilia-Romagna
Country [34] 0 0
Italy
State/province [34] 0 0
Friuli-Venezia Giulia
Country [35] 0 0
Italy
State/province [35] 0 0
Lazio
Country [36] 0 0
Italy
State/province [36] 0 0
Liguria
Country [37] 0 0
Italy
State/province [37] 0 0
Lombardia
Country [38] 0 0
Italy
State/province [38] 0 0
Piemonte
Country [39] 0 0
Italy
State/province [39] 0 0
Toscana
Country [40] 0 0
Korea, Republic of
State/province [40] 0 0
Busan
Country [41] 0 0
Korea, Republic of
State/province [41] 0 0
Jeollanam-do
Country [42] 0 0
Korea, Republic of
State/province [42] 0 0
Seoul
Country [43] 0 0
Netherlands
State/province [43] 0 0
Amsterdam
Country [44] 0 0
Netherlands
State/province [44] 0 0
Maastricht
Country [45] 0 0
New Zealand
State/province [45] 0 0
Auckland
Country [46] 0 0
Norway
State/province [46] 0 0
Bergen
Country [47] 0 0
Norway
State/province [47] 0 0
Oslo
Country [48] 0 0
Panama
State/province [48] 0 0
Panama City
Country [49] 0 0
Russian Federation
State/province [49] 0 0
Moscow
Country [50] 0 0
Russian Federation
State/province [50] 0 0
Saint-Petersburg
Country [51] 0 0
Russian Federation
State/province [51] 0 0
Sankt-Petersburg
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
Spain
State/province [55] 0 0
Valencia
Country [56] 0 0
Switzerland
State/province [56] 0 0
Basel
Country [57] 0 0
Switzerland
State/province [57] 0 0
Zürich
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Birmingham
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Cardiff
Country [60] 0 0
United Kingdom
State/province [60] 0 0
London
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Manchester
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Sutton

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a multicenter, double-blind, randomized, placebo-controlled study designed to compare overall survival in participants with relapsed or refractory AML treated with idasanutlin in combination with cytarabine versus participants treated with placebo and cytarabine. Participants will receive induction treatment with idasanutlin/placebo and cytarabine (Cycle 1). Responding participants may continue to receive a maximum of further two cycles of consolidation (Cycle 2 and Cycle 3). Complete remission (CR), CR with incomplete platelet count recovery (CRp), overall remission rate (ORR), event-free survival (EFS) and percentage of participants with an allogeneic hematopoietic stem cell transplant (HSCT) will also be compared between treatment arms. This study will include participants with and without TP53 wild type (TP53 WT) mutations.
Trial website
https://clinicaltrials.gov/study/NCT02545283
Trial related presentations / publications
Montesinos P, Beckermann BM, Catalani O, Esteve J, Gamel K, Konopleva MY, Martinelli G, Monnet A, Papayannidis C, Park A, Recher C, Rodriguez-Veiga R, Rollig C, Vey N, Wei AH, Yoon SS, Fenaux P. MIRROS: a randomized, placebo-controlled, Phase III trial of cytarabine +/- idasanutlin in relapsed or refractory acute myeloid leukemia. Future Oncol. 2020 May;16(13):807-815. doi: 10.2217/fon-2020-0044. Epub 2020 Mar 13.
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02545283