9-ING-41 for Myelofibrosis

Recruiting in Palo Alto (17 mi)

+10 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Actuate Therapeutics Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?9-ING-41 has anti-cancer clinical activity while not causing myelosuppression, and has both pre-clinical anti-fibrotic activity and activity against myelofibrosis. This Phase 2 study will study its efficacy in patients with advanced myelofibrosis.

Eligibility Criteria

Adults with advanced myelofibrosis who've tried Ruxolitinib for at least 12 weeks without success can join this trial. They must have proper organ function, not be pregnant or breastfeeding, and agree to use contraception. Excluded are those with recent heart attacks, hypersensitivity to the drug's components, vulnerable populations like prisoners, or using certain herbal medications.

Inclusion Criteria

Patient is aged ≥ 18 years

Patient has documented diagnosis of symptomatic primary MF, PPV-MF or PET-MF as defined by the World Health Organization classification

Patient is ineligible or unwilling to undergo stem cell transplantation at time of study entry

Patient has adequate performance status (PS): Eastern Co-operative Oncology Group (ECOG) PS 0-2

Exclusion Criteria

You had a heart attack within the past 12 weeks before starting the medication 9-ING-41.

Herbal preparations / medications are prohibited throughout the study. These herbal medications include, but are not limited to St. John's wort, Kava, ephedra (ma huang), Gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and Ginseng. Patients should stop using cannabinoids or herbal preparations/medications at least 7 days prior to first dose of study treatment

Participant Groups

The study is testing the effectiveness of a new treatment called 9-ING-41 in patients with advanced myelofibrosis. It's being given alongside Ruxolitinib—a previously attempted therapy—to see if it improves patient outcomes without causing additional bone marrow suppression.

2Treatment groups

Experimental Treatment

Group I: 9-ING-41 plus RuxolitinibExperimental Treatment2 Interventions

9-ING-41 9.3 mg/kg will be administered by intravenous infusion twice weekly for cycle durations of 28 days with Ruxolitinib at doses specified in the protocol as appropriate for patient's platelet count.

Group II: 9-ING-41Experimental Treatment1 Intervention

9-ING-41 is administered by intravenous infusion twice weekly at a dose of 9.3 mg/kg. Cycle duration is 28 days.