A Study to Evaluate Single Agent Selinexor Versus Physician's Choice in Participants With Previously Treated Myelofibrosis

Part of paid clinical trials in Pasadena, California.

Sponsor
Karyopharm Therapeutics Inc
Study ID
NCT04562870
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Myelofibrosis

Eligibility Criteria

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

Interventions

  • Selinexor — DRUG
    Unit Dose Strength: 20 mg; Dose Formulation: Tablet; Dosage Level: 60 or 80 mg, QW; Route of Administration: Oral
  • Physician's Choice Treatment — OTHER
    Physician's choice treatment may include ruxolitinib retreatment, fedratinib, chemotherapy (e.g., hydroxyurea), anagrelide, corticosteroid, hematopoietic growth factor, immunomodulatory agent, androgen, interferon (all as per clinical practice) and may include supportive care only with no MF treatment; no investigational therapies are allowed.

Study Details

This is a Phase 2, multicenter, two-arm, open-label study to evaluate the safety and efficacy of selinexor versus treatment per physician's choice (PC) in participants with myelofibrosis (MF) who had at least 6 months of treatment with a Janus kinase (JAK)1/2 inhibitor. Study participants will be randomized in a 1:1 ratio to either receive selinexor or physicians' choice of treatment.

Key Dates

Start date
Mar 17, 2021
Status verified
Sep 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

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

Arms

  • Experimental: Arm S: Selinexor
    Participants with MF who had previously received at least 6 months of treatment with JAK 1/2 inhibitor will receive a dose of selinexor 80 mg for first 2 cycles followed by selinexor 60 mg once weekly (QW) in subsequent cycles orally on Days 1, 8, 15, and 22 of each 28-day cycle to participants on Arm S.
  • Active Comparator: Arm PC: Physician's Choice Treatment
    Participants with MF who had previously received at least 6 months of treatment with JAK 1/2 inhibitor will receive Physician's choice treatment which will be administered as per clinical practice.

Primary Outcome Measure

Percentage of Participants with Spleen Volume Reduction of Greater Than or Equal to (≥) 35 Percent (%) (SVR35) [ Time Frame: From Baseline up to Week 24 ]

Locations (4)

FacilityCityStateZIPSite coordinators
The Oncology Institute of Hope and InnovationPasadenaCalifornia91105-
Rocky Mountain Cancer Centers, LLPAuroraColorado80012-
Illinois Cancer SpecialistNilesIllinois60714-
Texas Oncology - Northeast TexasTylerTexas75702-

Find similar trials in Pasadena, CA

By research site
The Oncology Institute of Hope and Innovation· Pasadena, CARocky Mountain Cancer Centers, LLP· Aurora, COIllinois Cancer Specialist· Niles, ILTexas Oncology - Northeast Texas· Tyler, TX

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