Selinexor in Myelofibrosis Refractory or Intolerant to JAK1/2 Inhibitors

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT03627403
Phase
PHASE2
Status
Terminated

Conditions

  • Post-essential Thrombocythemia Myelofibrosis
  • Post-polycythemia Vera Myelofibrosis
  • Primary Myelofibrosis

Eligibility Criteria

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

Interventions

  • Selinexor — DRUG
    Selinexor will be administered orally at a dose of 80 mg once weekly until IWG-MR disease progression, intolerable toxicity, or no clinical benefit per treating physician's discretion whichever occurs first. For patients enrolled after Protocol v7, Selinexor will be administered by oral route beginning at 40mg once weekly. Prior to protocol version 7, the starting dose of sSelinexor was 60 mg and 80 mg once weekly.

Study Details

This is a phase II, open label, prospective, single-arm study evaluating the efficacy and safety of selinexor in patients with PMF or secondary MF (PPV-MF or PET-MF) who are refractory or intolerant to ruxolitinib and/or any other experimental JAK1/2 inhibitors.

Key Dates

Start date
May 10, 2019
Status verified
May 2026
Primary completion
Aug 16, 2023
Completion
Mar 5, 2025

Study Design

Enrollment
17 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Selinexor, all patients
    Single Arm Study, all patients will get selinexor

Primary Outcome Measure

Count of Participants With Reduction in Spleen Volume [ Time Frame: Up to 5.5 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Huntsman Cancer Institute/University of UtahSalt Lake CityUtah84112-

Find similar trials in Salt Lake City, UT

By research site
Huntsman Cancer Institute/University of Utah· Salt Lake City, UT

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