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CompletedNCT01883362RADIUSUpdated Mar 17, 2021Results posted

Standard of Care +/- Midostaurin to Prevent Relapse Post Stem Cell Transplant in Patients With FLT3-ITD Mutated AML

A Phase 2 interventional study of Midostaurin and Standard of Care in Acute Myeloid Leukemia, sponsored by Novartis Pharmaceuticals. Completed at 19 sites in 2 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-03-17.

Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

To determine if the addition of midostaurin (PKC412) to Standard of Care (SOC) therapy reduces relapse in FLT3-ITD mutated AML patients receiving an allogenetic hematopoietic stem cell transplant,

02

Conditions studied

  • Acute Myeloid Leukemia

Keywords

  • acute myeloid leukemia
  • AML
  • FLT3-ITD
  • midostaurin
  • PKC412
  • allogeneic hematopoeitic stem cell tranplant
  • SCT
  • HSCT
  • CR1
  • adult
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 60 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients between 18 and 70 years of age
  • Patients with ECOG Performance Status of ≤ 2
  • Patients with a documented unequivocal diagnosis of AML according to WHO 2008 classification (>20% blasts in the bone marrow), excluding M3 (acute promyelocytic leukemia).
  • Patients with a documented FLT3 ITD mutation, determined by local laboratory for eligibility (historical tissue will be requested for central analysis confirmation)
  • Patients who undersent allogeneic HSCT in CR1 from a matched related or matched unrelated donor. All of the following criteria had to be met: HLA typing to include available 8/8 or 7/8 allele HLA matched donor (at A,B,C, DRB1) Single allelic mismatch allowed
  • Patients who had received a conditioning regimen which included one of the following:

Busulfan/Fludarabine (Bu/Flu) Busulfan (16 mg/kg PO or 12.8 mg/kg IV) Fludarabine (120-180 mg/m2) Fludarabine / Melphalan (Flu/Mel) Fludarabine (120-180 mg/m2) Melphalan (≤ 150 mg/m2) Busulfan/Cyclophosphamide (Bu/Cy) Busulfan (16 mg/kg PO or 12.8 mg/kg IV) Cyclophosphamide (120 mg/kg) Cyclophosphamide/Total Body Irradiation (Cy/TBI) Cyclophosphamide (120 mg/kg) TBI (1200-1420 cGy)

  • Recovery of counts by day 42 and was able to start midostaurin by day 60 post-HSCT (first dose of midostaurin to start no earlier than 28 days post-HSCT); ANC >1000µL, platelets ≥20,000 without platelet transfusion

Exclusion criteria

Exclusion Criteria:

Patients eligible for this study must not have met any of the following criteria:

  • Patients who failed prior attempts at allogeneic HSCT
  • Patients who had received an autologous transplant
  • Patients with Acute GVHD Grade III-IV
  • Patients with a known confirmed diagnosis of HIV infection or active viral hepatitis.

  • Impaired cardiac function including any of the following:

    • Screening ECG with a QTc > 450 msec. If QTc > 450 and electrolytes were not within normal ranges, electrolytes should be corrected and then the patient rescreened for QTc.
    • Patients with congenital long QT syndrome
    • History or presence of sustained ventricular tachycardia
    • Any history of ventricular fibrillation or torsades de pointes
    • Bradycardia defined as HR. \< 50 bpm
    • Right bundle branch block + left anterior hemiblock (bifascicular block)
    • Patients with myocardial infarction or unstable angina \< 6 months prior to starting study
    • Congestive Heart Failure NY Heart Association class III or IV
    • Patients with an ejection fraction \< 45% assessed by MUGA or ---ECHO within 28 days prior to starting study cycle 1 (of midostaurin or control group)
  • Patients with any pulmonary infiltrate including those suspected to be of infectious origin (unless resolves to ≤ Grade 1 within screening timeframe)
  • Patient required treatment with strong CYP3A4 inhibitors or moderate or strong CYP3A4 inducers other than those required for GVH or infection prophylaxis or treatment

Pregnant or nursing (lactating) women, or women of child-bearing potential, must have used highly effective methods of contraception during dosing and for 30 days after treatment completion

05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Standard of Care with Midostaurin

    Patients received standard of care in the post stem cell transplant (SCT) setting in addition to Midostaurin 50mg twice a day for 12 months (cycles).

    Drug: Midostaurin

  • Active comparator
    Standard of Care

    Patients received standard of care alone in the post SCT setting

    Other: Standard of Care

Interventions

  • DrugMidostaurin

    Midostaurin was supplied in 25mg soft gelatin capsule taken orally twice a day for 28 days of each cycle. Patients will be treated for 12 cycles.

    Also known as: PKC412

  • OtherStandard of Care

    Standard of Care was not defined per protocol. The investigator prescribed based on the commonly used medications given in the post SCT setting.

06

What researchers measure

Primary outcomes

  1. Proportion of Participants With Relapse Free Survival (RFS) up to 18 Months Post Transplant (Full Analysis Set) by Kaplan-Meier Analysis

    Relapse-free survival assesses the clinical benefit of remaining in remission free from relapse or death due to the disease. It was defined as the time from transplant to relapse or death due to the disease. Relapse following complete response was defined as reappearance of leukemic blasts in the peripheral blood or finding more than 5% blasts in the bone marrow.

    Time frame: date of transplant up to 18 months

Secondary outcomes

  1. Proportion of Participants With Relapse Free Survival (RFS) - Time From Randomization up to 18 Months (Full Analysis Set) by Kaplan-Meier Analysis

    Relapse-free survival assesses the clinical benefit of remaining in remission free from relapse or death due to the disease. It was defined as the time from transplant to relapse or death due to the disease. Relapse following complete response was defined as reappearance of leukemic blasts in the peripheral blood or finding more than 5% blasts in the bone marrow.

    Time frame: Randomization to 18 months

  2. Proportion of Participants With Relapse Free Survival (RFS) - Time From Randomization up to 24 Months(Full Analysis Set) by Kaplan-Meier Analysis

    DFS was defined as the time from transplant to relapse or death due to any cause. If a patient had more than 1 event (e.g., relapse then death) then the earliest date was taken into account.

    Time frame: date of transplant up to 24 months

  3. Proportion of Participants With Relapse Free Survival (RFS) - Time From Transplant (Full Analysis Set) by Kaplan-Meier Analysis

    Relapse-free survival was defined as the time from transplant to relapse or death due to the disease 24 months post-transplant. If a patient had more than one event (e.g., relapse then death) then the earliest date was taken into account.

    Time frame: date of transplant up to 24 months

  4. Probability of Overall Survival - Date of Transplant up to 24 Months (Full Analysis Set) by Kaplan-Meier Analysis

    Overall survival was defined as the time from transplant to death due to any cause.

    Time frame: date of transplant up to 24 months

  5. Probability of Non-relapse Mortality (NRM) - Date of Transplant up to 24 Months (Full Analysis Set) by Kaplan-Meier Analysis

    Non-relapse mortality (NRM) was defined as the time from transplant to death due to reasons other than relapse/progressive disease

    Time frame: date of transplant up to 24 months

  6. FLT3-ITD Mutation Status Centrally in Archived Material From Diagnosis (if Available) Including Mutant:Wild Type Ratio.

    Unable to retrieve a sufficient amount of archived samples to perform an analysis therefore the study was not able to verify the FLT3-ITD mutation status

    Time frame: up to 24 months from date of transplannt or at study completion

  7. Plasma Pharmacokinetics (PK) of Midostaurin and the Metabolites: CGP62221 and CGP52421: Pre-dose Levels

    Pre-dose levels (Cmin) will be directly determined from raw plasma concentration-time data. Values below the lower limit of quantification (LLOQ) will be treated as zero in any calculations of summary statistics.

    Time frame: Pre-dose on days 1 and 15 of Cycle 1, on day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

07

Results

Posted Mar 17, 2021

Participant flow

Treatment
Participant flow — Treatment
MilestoneStandard of Care With MidostaurinStandard of Care
Started3030
Completed1416
Not completed1614
Withdrew: Adverse event18
Withdrew: Withdrawal by subject62
Withdrew: Administrative problems41
Withdrew: Relapse42
Withdrew: Randomized, not treated11
Post Treatment Follow-up
Participant flow — Post Treatment Follow-up
MilestoneStandard of Care With MidostaurinStandard of Care
Started2627
Completed1013
Not completed1614
Withdrew: Protocol violation01
Withdrew: Withdrawal by subject43
Withdrew: Lost to follow-up14
Withdrew: Administrative problems20
Withdrew: Death84
Withdrew: Relapse12

Outcome measures

PrimaryProportion of Participants With Relapse Free Survival (RFS) up to 18 Months Post Transplant (Full Analysis Set) by Kaplan-Meier Analysis

Relapse-free survival assesses the clinical benefit of remaining in remission free from relapse or death due to the disease. It was defined as the time from transplant to relapse or death due to the disease. Relapse following complete response was defined as reappearance of leukemic blasts in the peripheral blood or finding more than 5% blasts in the bone marrow.

Time frame:
date of transplant up to 18 months
Reported as:
Number · proportion of participants
Proportion of Participants With Relapse Free Survival (RFS) up to 18 Months Post Transplant (Full Analysis Set) by Kaplan-Meier Analysis
proportion of participantsStandard of Care With MidostaurinStandard of Care
6 months0.93 (0.75 to 0.98)0.93 (0.74 to 0.98)
12 months0.80 (0.59 to 0.91)0.93 (0.74 to 0.98)
18 months0.76 (0.54 to 0.88)0.89 (0.69 to 0.96)
Statistical analysis
  • Standard of Care With Midostaurin vs Standard of Care · Log Rank · p = 0.2655 · Hazard ratio (hr): 0.46 · 95% CI 0.12 to 1.86
SecondaryProportion of Participants With Relapse Free Survival (RFS) - Time From Randomization up to 18 Months (Full Analysis Set) by Kaplan-Meier Analysis

Relapse-free survival assesses the clinical benefit of remaining in remission free from relapse or death due to the disease. It was defined as the time from transplant to relapse or death due to the disease. Relapse following complete response was defined as reappearance of leukemic blasts in the peripheral blood or finding more than 5% blasts in the bone marrow.

Time frame:
Randomization to 18 months
Reported as:
Number · Proportion of participants
Proportion of Participants With Relapse Free Survival (RFS) - Time From Randomization up to 18 Months (Full Analysis Set) by Kaplan-Meier Analysis
Proportion of participantsStandard of Care With MidostaurinStandard of Care
6 months0.93 (0.75 to 0.98)0.93 (0.74 to 0.98)
12 months0.80 (0.59 to 0.91)0.93 (0.74 to 0.98)
18 months0.76 (0.54 to 0.88)0.85 (0.64 to 0.94)
Statistical analysis
  • Standard of Care With Midostaurin vs Standard of Care · Log Rank · p = 0.4297 · Hazard ratio (hr): 0.60 · 95% CI 0.17 to 2.14
SecondaryProportion of Participants With Relapse Free Survival (RFS) - Time From Randomization up to 24 Months(Full Analysis Set) by Kaplan-Meier Analysis

DFS was defined as the time from transplant to relapse or death due to any cause. If a patient had more than 1 event (e.g., relapse then death) then the earliest date was taken into account.

Time frame:
date of transplant up to 24 months
Reported as:
Number · Proportion of participants
Proportion of Participants With Relapse Free Survival (RFS) - Time From Randomization up to 24 Months(Full Analysis Set) by Kaplan-Meier Analysis
Proportion of participantsStandard of Care With MidostaurinStandard of Care
6 months0.90 (0.71 to 0.96)0.93 (0.74 to 0.98)
12 months0.77 (0.56 to 0.89)0.89 (0.70 to 0.96)
18 months0.69 (0.48 to 0.83)0.85 (0.65 to 0.94)
24 months0.69 (0.48 to 0.83)0.81 (0.61 to 0.92)
Statistical analysis
  • Standard of Care With Midostaurin vs Standard of Care · Log Rank · p = 0.2424 · Hazard ratio (hr): 0.55 · 95% CI 0.20 to 1.52
SecondaryProportion of Participants With Relapse Free Survival (RFS) - Time From Transplant (Full Analysis Set) by Kaplan-Meier Analysis

Relapse-free survival was defined as the time from transplant to relapse or death due to the disease 24 months post-transplant. If a patient had more than one event (e.g., relapse then death) then the earliest date was taken into account.

Time frame:
date of transplant up to 24 months
Reported as:
Number · Proportion of participants
Proportion of Participants With Relapse Free Survival (RFS) - Time From Transplant (Full Analysis Set) by Kaplan-Meier Analysis
Proportion of participantsStandard of Care With MidostaurinStandard of Care
6 months0.93 (0.75 to 0.98)0.93 (0.74 to 0.98)
12 months0.80 (0.59 to 0.91)0.93 (0.74 to 0.98)
18 months0.76 (0.54 to 0.88)0.89 (0.69 to 0.96)
24 months0.76 (0.54 to 0.88)0.85 (0.64 to 0.94)
Statistical analysis
  • Standard of Care With Midostaurin vs Standard of Care · Log Rank · p = 0.4297 · Hazard ratio (hr): 0.60 · 95% CI 0.17 to 2.14
SecondaryProbability of Overall Survival - Date of Transplant up to 24 Months (Full Analysis Set) by Kaplan-Meier Analysis

Overall survival was defined as the time from transplant to death due to any cause.

Time frame:
date of transplant up to 24 months
Reported as:
Number · proportion of participants
Probability of Overall Survival - Date of Transplant up to 24 Months (Full Analysis Set) by Kaplan-Meier Analysis
proportion of participantsStandard of Care With MidostaurinStandard of Care
6 months0.96 (0.71 to 0.96)1.00 (1.00 to 1.00)
12 months0.89 (0.56 to 0.89)0.89 (0.69 to 0.96)
18 months0.76 (0.54 to 0.89)0.85 (0.65 to 0.94)
24 months0.76 (0.54 to 0.89)0.85 (0.65 to 0.94)
Statistical analysis
  • Standard of Care With Midostaurin vs Standard of Care · Log Rank · p = 0.3418 · Hazard ratio (hr): 0.58 · 95% CI 0.19 to 1.79
SecondaryProbability of Non-relapse Mortality (NRM) - Date of Transplant up to 24 Months (Full Analysis Set) by Kaplan-Meier Analysis

Non-relapse mortality (NRM) was defined as the time from transplant to death due to reasons other than relapse/progressive disease

Time frame:
date of transplant up to 24 months
Reported as:
Number · proportion of participants
Probability of Non-relapse Mortality (NRM) - Date of Transplant up to 24 Months (Full Analysis Set) by Kaplan-Meier Analysis
proportion of participantsStandard of Care With MidostaurinStandard of Care
6 months0.96 (0.77 to 0.99)1.00 (1.00 to 1.00)
12 months0.96 (0.77 to 0.99)0.96 (0.76 to 0.99)
18 months0.92 (0.71 to 0.98)0.96 (0.76 to 0.99)
24 months0.92 (0.71 to 0.98)0.96 (0.76 to 0.99)
Statistical analysis
  • Standard of Care With Midostaurin vs Standard of Care · Log Rank · p = 0.4169 · Hazard ratio (hr): 0.50 · 95% CI 0.09 to 2.74
SecondaryFLT3-ITD Mutation Status Centrally in Archived Material From Diagnosis (if Available) Including Mutant:Wild Type Ratio.

Unable to retrieve a sufficient amount of archived samples to perform an analysis therefore the study was not able to verify the FLT3-ITD mutation status

Time frame:
up to 24 months from date of transplannt or at study completion

No measurements were reported for this outcome.

SecondaryPlasma Pharmacokinetics (PK) of Midostaurin and the Metabolites: CGP62221 and CGP52421: Pre-dose Levels

Pre-dose levels (Cmin) will be directly determined from raw plasma concentration-time data. Values below the lower limit of quantification (LLOQ) will be treated as zero in any calculations of summary statistics.

Time frame:
Pre-dose on days 1 and 15 of Cycle 1, on day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Reported as:
Mean · ng/ml
Plasma Pharmacokinetics (PK) of Midostaurin and the Metabolites: CGP62221 and CGP52421: Pre-dose Levels
ng/mlPKC412Metabolite CGP52421Metabolite CGP62221
Visit 2,Cycle1,Day 117.46 ± 76.8060.00 ± 0.00016.89 ± 61.212
Visit 4,Cycle1, Day 15932.46 ± 770.5971572.69 ± 684.955906.57 ± 747.836
Visit 5,Cycle2,Day 1769.92 ± 485.3531768.77 ± 849.580779.90 ± 400.244
Visit 6,Cycle3,Day 1907.20 ± 528.0172051.55 ± 765.758929.45 ± 311.841
Visit 7,Cycle4,Day 1548.45 ± 459.2941707.15 ± 810.143714.00 ± 610.925
Visit 8,Cycle5,Day 1525.73 ± 255.0321742.85 ± 658.905722.00 ± 320.977
Visit 9,Cycle6,Day 1519.10 ± 328.0321757.86 ± 685.740763.86 ± 408.290
Visit 10,Cycle 7 Day 1754.95 ± 497.9761717.35 ± 720.259780.65 ± 424.200
Visit 11,Cycle 8 Day 1537.95 ± 229.5291787.21 ± 733.162774.84 ± 326.583
Visit 12,Cycle 9 Day 1571.76 ± 311.7641889.76 ± 678.435850.47 ± 328.411
Visit 13,Cycle 10 Day 1643.07 ± 452.2681836.50 ± 632.894851.38 ± 347.311
Visit 14,Cycle 11 Day 1718.22 ± 538.2081857.33 ± 868.406983.94 ± 801.361
Visit 15,Cycle 12 Day 1564.69 ± 410.1561706.29 ± 643.326763.60 ± 387.685
Post-hocAll Collected Deaths

On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months). Deaths post treatment survival follow up were collected after the on treatment period, up to approximately 51 months.

Time frame:
approx. 12.5 months, approx. 51 months
Reported as:
Number · Participants
All Collected Deaths
ParticipantsStandard of Care With MidostaurinStandard of Care
Total Deaths84
Deaths on-treatment10

Adverse events

Collected over Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Standard of Care With Midostaurin1/30 (3.3%)9/30 (30%)28/30 (93.3%)
Standard of Care0/30 (0%)15/30 (50%)26/30 (86.7%)
ALL Patients1/60 (1.7%)24/60 (40%)54/60 (90%)
Most frequent serious events
Showing 10 of 60
Most frequent serious events
EventStandard of Care With MidostaurinStandard of CareALL Patients
DiarrhoeaGastrointestinal disorders4/302/306/60
NauseaGastrointestinal disorders1/303/304/60
AnaemiaBlood and lymphatic system disorders2/301/303/60
Febrile neutropeniaBlood and lymphatic system disorders1/302/303/60
VomitingGastrointestinal disorders1/302/303/60
PyrexiaGeneral disorders2/302/304/60
Acute kidney injuryRenal and urinary disorders0/302/302/60
NeutropeniaBlood and lymphatic system disorders1/300/301/60
PancytopeniaBlood and lymphatic system disorders1/300/301/60
Arteriosclerosis coronary arteryCardiac disorders0/301/301/60
Most frequent other events
Showing 10 of 117
Most frequent other events
EventStandard of Care With MidostaurinStandard of CareALL Patients
VomitingGastrointestinal disorders20/305/3025/60
NauseaGastrointestinal disorders19/305/3024/60
Oedema peripheralGeneral disorders6/3010/3016/60
DiarrhoeaGastrointestinal disorders9/304/3013/60
HeadacheNervous system disorders8/305/3013/60
CoughRespiratory, thoracic and mediastinal disorders8/306/3014/60
FatigueGeneral disorders7/307/3014/60
Aspartate aminotransferase increasedInvestigations5/307/3012/60
Neutrophil count decreasedInvestigations7/303/3010/60
Upper respiratory tract infectionInfections and infestations3/306/309/60

Baseline characteristics

Age, Continuous
Age, Continuous(years)Standard of Care With MidostaurinStandard of CareTotal
Mean50.8 ± 13.6846.0 ± 11.0848.4 ± 12.58
Sex: Female, Male
Sex: Female, Male(Participants)Standard of Care With MidostaurinStandard of CareTotal
Female141226
Male161834
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Standard of Care With MidostaurinStandard of CareTotal
Caucasian272754
Black101
Asian112
Other123
Body Mass Index
Body Mass Index(kg/m^2)Standard of Care With MidostaurinStandard of CareTotal
Mean26.9934 ± 7.1136826.6400 ± 5.2747526.8101 ± 6.17055
08

Study locations

19 sites
  • University of California San Diego Moores Cancer Center
    La Jolla, California 92093-0987, United States
  • University of California at Los Angeles Oncology
    Los Angeles, California 90095, United States
  • SCRI- Colorado Blood Cancer Institute
    Denver, Colorado 80218, United States
  • H Lee Moffitt Cancer Center and Research Institute Oncology
    Tampa, Florida 33612, United States
  • Northside Hospital
    Atlanta, Georgia 30342, United States
  • University of Chicago Medical Center
    Chicago, Illinois 60637, United States
  • Karmanos Cancer Institute Karmanos - Wayne State
    Detroit, Michigan 48201, United States
  • Mayo Clinic - Rochester
    Rochester, Minnesota 55905, United States
  • Washington University School Of Medicine-Siteman Cancer Ctr Washington U School of Med
    Saint Louis, Missouri 63110, United States
  • Hackensack University Medical Center Hackensack Univ Med Ctr (32)
    Hackensack, New Jersey 07601, United States
  • University of North Carolina at Chapel Hill University of North Carolina 6
    Chapel Hill, North Carolina 27599-9500, United States
  • University Hospitals Case Medical Center
    Cleveland, Ohio 44106, United States
  • Oregon Health Sciences University
    Portland, Oregon 97239, United States
  • Tennessee Oncology Sarah Cannon Research Inst.
    Nashville, Tennessee 37203, United States
  • Vanderbilt Univeristy Oncology
    Nashville, Tennessee 37232, United States
  • Baylor Health Care System/Sammons Cancer Center Oncology
    Dallas, Texas 75246, United States
  • Texas Transplant Physicians Group Oncology 2
    San Antonio, Texas 78229, United States
  • Fred Hutchinson Cancer Research Center Oncology
    Seattle, Washington 98109, United States
  • Novartis Investigative Site
    Toronto, Ontario M5G 2M9, Canada
09

References and documents

Publications

  • Maziarz RT, Levis M, Patnaik MM, Scott BL, Mohan SR, Deol A, Rowley SD, Kim DDH, Hernandez D, Rajkhowa T, Haines K, Bonifacio G, Rine P, Purkayastha D, Fernandez HF. Midostaurin after allogeneic stem cell transplant in patients with FLT3-internal tandem duplication-positive acute myeloid leukemia. Bone Marrow Transplant. 2021 May;56(5):1180-1189. doi: 10.1038/s41409-020-01153-1. Epub 2020 Dec 7. PubMed 33288862 ↗

Study documents

  • Study protocol · Jul 2, 2015
  • Statistical analysis plan · Feb 7, 2018

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01883362
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Jun 21, 2013
Start date
Feb 6, 2014
Primary completion
Apr 30, 2018
Completion
Apr 30, 2018
Results posted
Mar 17, 2021
Last update
Mar 17, 2021

Study contacts

Brian Elliott, MD
study director · Novartis Pharmaceuticals

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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