Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Kartos Therapeutics, Inc.
Study ID
NCT06479135
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • MF
  • Myelofibrosis
  • Post-ET Myelofibrosis
  • Post-PV MF
  • Primary Myelofibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Navtemadlin — DRUG
    Navtemadlin is an investigational MDM2 inhibitor
  • Navtemadlin placebo — DRUG
    Navtemadlin placebo
  • Ruxolitinib — DRUG
    Ruxolitinib is a janus kinase 1/2 inhibitor

Study Details

This clinical trial is evaluating whether addition of navtemadlin to ruxolitinib treatment will provide more clinical benefit than ruxolitinib alone for patients with Myelofibrosis who have a suboptimal response to ruxolitinib treatment alone. Subjects will start by receiving ruxolitinib alone in the run-in period. Those who demostrate a suboptimal response from ruxolitinib alone will then be randomized 2:1 to receive navtemadlin or navtemadlin placebo as add-on treatment to their ongoing ruxolitinib. Randomized means that subjects will be assigned to a group by chance, like a flip of a coin. The study is blinded, meaning the subjects, doctors, central endpoint assessors and sponsor will not know which add on treatment (navtemadlin or navtemadlin placebo) the subject is receiving.

Key Dates

Start date
Jun 3, 2024
Status verified
Oct 2024
Primary completion
Dec 31, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Navtemadlin administered orally once daily on Days 1-7, off treatment on Days 8-28, in 28-day treatment cycles. Ruxolitinib administered orally twice a day.
  • Active Comparator: Arm 2
    Navtemadlin placebo administered orally once daily on Days 1-7, off treatment on Days 8-28, in 28-day treatment cycles. Ruxolitinib administered orally twice a day.

Primary Outcome Measure

To compare spleen volume reduction (SVR35) between Arm 1 and Arm 2 [ Time Frame: 24 weeks ]

Central Contacts

Locations (58)

FacilityCityStateZIPSite coordinators
UAB HospitalBirminghamAlabama35233-
Banner MD Anderson Cancer CenterGilbertArizona85234-
Mayo Clinic - PhoenixPhoenixArizona85054-
UC San Diego Moores Cancer CenterLa JollaCalifornia92037-
UCLA Hematology/Oncology Clinic - Los AngelesLos AngelesCalifornia90095-
Scripps Health, Prebys Cancer CenterSan DiegoCalifornia92103-
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterTorranceCalifornia90502-
Rocky Mountain Cancer Centers - AuroraAuroraColorado80012-
Medical Oncology Hematology Consultants, PANewarkDelaware19713-
MedStar Georgetown University Hospital, Lombardi Comprehensive Cancer CenterWashington D.C.District of Columbia20007-
Mayo Clinic - JacksonvilleJacksonvilleFlorida32224-
University of MiamiMiamiFlorida33136-
AdventHealth Cancer InstituteOrlandoFlorida32803-
Moffitt Cancer CenterTampaFlorida33612-
Mission Cancer + BloodDes MoinesIowa50314-
University of Kansas Cancer Center - WestwoodWestwoodKansas66205-
Norton Cancer InstituteLouisvilleKentucky40207-
Mary Bird Perkins Cancer CenterBaton RougeLouisiana70809-
Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21231-
The Center for Cancer and Blood DisordersBethesdaMaryland20817-
Dana Farber Cancer InstituteBostonMassachusetts02215-
University of Michigan HospitalAnn ArborMichigan48109-
Henry Ford Cancer Institute - Brigitte Harris Cancer PavilionDetroitMichigan48202-
Nebraska Hematology - Oncology, P.C.LincolnNebraska68506-
Mohtaseb Cancer Center and Blood DisordersHendersonNevada86442-
Hackensack University Medical CenterHackensackNew Jersey07601-
Brookdale University Hospital and Medical CenterBrooklynNew York11212-
Cayuga Cancer CenterIthacaNew York14850-
Northwell Health, R.J. Zuckerberg Cancer CenterLake SuccessNew York11042-
ICAHN School of Medicine at Mount SinaiNew YorkNew York10029-6574-
Montefiore Einstein Comprehensive Cancer CenterThe BronxNew York10467-
Medical University of South Carolina (MUSC)CharlestonNorth Carolina29425-8900-
Atrium Health Levine Cancer InstituteCharlotteNorth Carolina28204-
Duke University Medical CenterDurhamNorth Carolina27710-
Regional Medical Oncology CenterWilsonNorth Carolina27893-
Atrium Health Wake Forest BaptistWinston-SalemNorth Carolina27157-
Gabrail Cancer CenterCantonOhio44718-
University of Cincinnati Medical CenterCincinnatiOhio45219-
Cleveland ClinicClevelandOhio44195-
Cleveland Clinic Cancer Center at Fairview HospitalClevelandOhio44111-
Independence Family Health Center - Cleveland ClinicIndependenceOhio44131-
Hillcrest Hospital - Cleveland ClinicMayfield HeightsOhio44124-
Willamette Valley Cancer Institute and Research CenterEugeneOregon97401-
Abramson Cancer Center of the University of PennsylvaniaPhiladelphiaPennsylvania19104-
West Penn HospitalPittsburghPennsylvania15224-
Tennessee OncologyChattanoogaTennessee37404-
Tennessee OncologyNashvilleTennessee37203-
Vanderbilt University Medical CenterNashvilleTennessee37232-
UT - SouthWesternDallasTexas75390-
U.T. MD Anderson Cancer CenterHoustonTexas77030-
The University of Texas Health Science Center at San AntonioSan AntonioTexas78229-
University of Utah, Huntsman Cancer InstituteSalt Lake CityUtah84112-
VCU Medical CenterRichmondVirginia23298-
Virginia Cancer InstituteRichmondVirginia23229-
Virginia Oncology Associates - Virginia BeachVirginia BeachVirginia23456-
Fred Hutchinson Cancer CentreSeattleWashington98109-
Northwest Medical Specialties, PLLC - TacomaTacomaWashington98405-
Sheboygan Cancer & Blood SpecialistsSheboyganWisconsin53081-

Find similar trials in Birmingham, AL

By research site
UAB Hospital· Birmingham, ALBanner MD Anderson Cancer Center· Gilbert, AZMayo Clinic - Phoenix· Phoenix, AZUC San Diego Moores Cancer Center· La Jolla, CAUCLA Hematology/Oncology Clinic - Los Angeles· Los Angeles, CAScripps Health, Prebys Cancer Center· San Diego, CA

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