Trials / Terminated
TerminatedNCT03627403
Selinexor in Myelofibrosis Refractory or Intolerant to JAK1/2 Inhibitors
A Phase II Study to Evaluate the Efficacy and Safety of Selinexor in Patients With Myelofibrosis Refractory or Intolerant to JAK1/2 Inhibitors
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- University of Utah · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
- Primary Myelofibrosis
- Post-essential Thrombocythemia Myelofibrosis
- Post-polycythemia Vera Myelofibrosis
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Selinexor | 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. |
Timeline
- Start date
- 2019-05-10
- Primary completion
- 2023-08-16
- Completion
- 2025-03-05
- First posted
- 2018-08-13
- Last updated
- 2025-06-19
- Results posted
- 2024-10-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03627403. Inclusion in this directory is not an endorsement.