Selinexor for Myelofibrosis
(ESSENTIAL Trial)

Recruiting in Palo Alto (17 mi)

Srinivas K. Tantravahi | University of ...

Overseen bySrinivas Tantravahi

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Utah

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing selinexor, a medication that may help treat certain blood disorders. It focuses on patients with primary or secondary myelofibrosis who do not respond to or cannot tolerate common treatments like ruxolitinib. Selinexor works by blocking a protein that helps harmful cells grow and survive. Selinexor is the first oral selective inhibitor of nuclear export compound tested for cancer treatment.

Research Team

Srinivas Tantravahi

Principal Investigator

University of Utah

Eligibility Criteria

Adults diagnosed with primary or secondary myelofibrosis who haven't responded well to, or can't tolerate, JAK1/2 inhibitors like ruxolitinib. They should be relatively active (ECOG ≤ 2), have a spleen enlarged by at least 5 cm if symptomatic or 10 cm regardless of symptoms, and meet specific blood count and organ function criteria.

Inclusion Criteria

I have recovered from previous cancer treatment side effects, or they are mild and stable.

My blood, liver, and kidney functions are within normal ranges.

Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines

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Exclusion Criteria

I have not had major surgery in the last 4 weeks.

My body surface area is less than 1.4 square meters.

I do not have an active infection needing IV drugs within the last week.

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Treatment Details

Interventions

Selinexor (Selective Inhibitor of Nuclear Export (SINE))

Trial OverviewThe trial is testing Selinexor's effectiveness and safety in patients with myelofibrosis who don't benefit from current treatments. It's an open-label study where all participants receive the drug; there's no comparison group.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Selinexor, all patientsExperimental Treatment1 Intervention

Single Arm Study, all patients will get selinexor

Selinexor is already approved in Canada for the following indications: