A Phase 1/3 Study to Assess Selinexor Plus Ruxolitinib in People with Untreated Myelofibrosis

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Full Title

A Phase 1/3 Study to Evaluate the Efficacy and Safety of Selinexor, a Selective Inhibitor of Nuclear Export, in Combination with Ruxolitinib in Treatment-naïve Patients with Myelofibrosis (WIRB)

Purpose

Ruxolitinib is a medicine used to treat myelofibrosis. In this study, researchers want to see if adding the drug selinexor to ruxolitinib is better than ruxolitinib alone. Both drugs are taken orally (by mouth).

Selinexor works by trapping proteins inside cancer cells that block tumor growth. Selinexor also makes it easier for the immune system to work against cancer cells.

If you join this study, you will get one of these treatments:

  • Selinexor plus ruxolitinib
  • Placebo (inactive drug) plus ruxolitinib

Who Can Join

To join this study, there are a few conditions. You must:

  • Have myelofibrosis that is causing symptoms and has not yet been treated.
  • Be able to walk and do routine activities for more than half the time you are awake.
  • Be age 18 or older.

Contact

For more information and to see if you can join this study, please call Dr. Raajit Rampal’s office at 646-608-3746.

Protocol

23-386

Phase

Phase III (phase 3)

Disease Status

Newly Diagnosed

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT04562389