Selinexor for Myelofibrosis

Recruiting at 41 trial locations

Overseen By Karyopharm Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Karyopharm Therapeutics Inc

Must be taking: JAK inhibitors

Must not be taking: Strong CYP3A inhibitors, inducers

Disqualifiers: Accelerated phase, Selinexor, GI impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 28-day cycles

112 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing selinexor, a medication that aims to stop harmful cells from growing, in patients with myelofibrosis. Selinexor is the first oral selective inhibitor of nuclear export compound tested for cancer treatment, showing broad antitumor activity. These patients have already tried another treatment for a significant period without full success. The study will compare selinexor to other treatments chosen by doctors to see which works better.

Eligibility Criteria

Adults diagnosed with myelofibrosis who have been treated with JAK inhibitors for at least 6 months can join. They must be in good general health, not pregnant or breastfeeding, and willing to use contraception. People cannot join if they have a high percentage of blasts in blood or bone marrow, severe gastrointestinal issues affecting drug absorption, recent major surgery, life-threatening conditions, or previous treatment with selinexor.

Inclusion Criteria

I am a man who will use effective birth control during and for 3 months after the study, and won't donate sperm.

My spleen is enlarged, measuring over 450 cm^3 on an MRI or CT scan.

I have hepatitis C but my viral load is undetectable.

Exclusion Criteria

I do not have severe GI issues that could affect medication absorption.

I haven't taken any standard or experimental treatments for myelofibrosis in the last 21 days, except for hydroxyurea or growth factors.

I haven't taken strong CYP3A affecting drugs within the last week.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either selinexor or physician's choice treatment. Selinexor is administered as 80 mg for the first 2 cycles followed by 60 mg once weekly in subsequent cycles.

28-day cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Selinexor

Trial Overview The trial is testing the safety and effectiveness of Selinexor compared to other treatments chosen by physicians for those with myelofibrosis previously treated with JAK inhibitors. Participants will be randomly assigned to either receive Selinexor or a physician's choice treatment in an open-label study.

Participant Groups

Group I: Arm S: Selinexor Experimental Treatment 1 Intervention

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.

Group II: Arm PC: Physician's Choice Treatment Active Control 1 Intervention

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.

Selinexor is already approved in United States, Canada for the following indications:

Approved in United States as Xpovio for:

• Multiple myeloma
• Diffuse large B-cell lymphoma

Approved in Canada as Xpovio for:

• Multiple myeloma

Who Is Running the Clinical Trial?

Karyopharm Therapeutics Inc

Lead Sponsor

Trials

89

Recruited

7,200+

Richard Paulson

Karyopharm Therapeutics Inc

Chief Executive Officer since 2021

MBA from the University of Toronto's Rotman School of Management

Reshma Rangwala

Karyopharm Therapeutics Inc

Chief Medical Officer since 2023

MD, PhD