A Study of Selinexor Monotherapy in Subjects With JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia

Part of paid clinical trials in Duarte, California.

Sponsor
Karyopharm Therapeutics Inc
Study ID
NCT05980806
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Mild Thrombocytopenia
  • Moderate Thrombocytopenia
  • Myelofibrosis

Eligibility Criteria

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

Interventions

  • Selinexor 60 mg — DRUG
    Participants will receive selinexor 60 mg oral tablets QW.
  • Selinexor 40 mg — DRUG
    Participants will receive selinexor 40 mg oral tablets QW.
  • Ruxolitinib — DRUG
    Participants will receive ruxolitinib per local package insert.
  • Pacritinib — DRUG
    Participants will receive pacritinib per local package insert. For countries where not approved, 200 mg twice daily is the starting dose.
  • Momelotinib — DRUG
    Participants will receive momelotinib per local package insert.

Study Details

The main purpose of this study is to evaluate the efficacy of selinexor in JAKi-naïve participants with myelofibrosis (MF) and with normal platelet counts or with mild to moderate thrombocytopenia based on spleen volume reduction (SVR). Additional efficacy and safety parameters will also be assessed during the study.

Key Dates

Start date
Apr 22, 2024
Status verified
Feb 2026
Primary completion
Jun 30, 2027
Completion
Oct 31, 2028

Study Design

Enrollment
58 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Selinexor 60 mg (Arm 1)
    Participants will receive selinexor 60 milligrams (mg) oral tablets once weekly (QW) (Days 1, 8, 15, and 22 of each 28-day cycle) until PD, intolerable toxicity, or until they meet the criteria for discontinuation of study treatment. Optional add-on medication dosing may be initiated based on Spleen Volume Reduction (SVR) values at Week 12 or Week 24 of treatment.
  • Experimental: Selinexor 40 mg (Arm 2)
    Participants will receive selinexor 40 mg oral tablets QW (Days 1, 8, 15, and 22 of each 28-day cycle) until PD, intolerable toxicity, or until they meet the criteria for discontinuation of study treatment. Optional add-on medication dosing may be initiated based on Spleen Volume Reduction (SVR) values at Week 12 or Week 24 of treatment.

Primary Outcome Measure

Proportion of Participants with Spleen Volume Reduction ≥35% (SVR35) at Week 24 [ Time Frame: At Week 24 ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
City of Hope - Duarte Main SiteDuarteCalifornia91010
Haris Ali
[email protected]
6263564673
Haris Ali (PRINCIPAL_INVESTIGATOR)
Maryland Oncology Hematology - Independent of SCRI/ US OncologyColumbiaMaryland21044
Mohit Narang
[email protected]
304-942-9220
Mohit Narang (PRINCIPAL_INVESTIGATOR)
Weill Cornell Medicine NewYork-PresbyterianNew YorkNew York10021
Ellen Ritche
[email protected]
646-962-4580
Ellen Ritche (PRINCIPAL_INVESTIGATOR)
Duke UniversityDurhamNorth Carolina27705
Lindsay Rein
[email protected]
919-684-8964
Lindsay Rein (PRINCIPAL_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
Aaron Gerds
[email protected]
216-445-9840
Aaron Gerds (PRINCIPAL_INVESTIGATOR)
MD AndersonHoustonTexas77030
Prithviraj Bose
[email protected]
(713) 792-7747
Prithviraj Bose (PRINCIPAL_INVESTIGATOR)
Huntsman Cancer InstituteSalt Lake CityUtah84112
Srinivas Tantravahi
[email protected]
801-213-6170
Srinivas Tantravahi (PRINCIPAL_INVESTIGATOR)

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