Investigational Therapy for Previously Treated Patients with Myelofibrosis

Inclusion Criteria

• Be diagnosed with Primary Myelofibrosis(PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF).
• Have been treated with ruxolitinib for =3 months with a stable dose for at least the last 8 weeks.
• Have a suboptimal response to Ruxolitinib.
• Be 18 years or older.
• Be willing to avoid pregnancy, fathering a child, or donating sperm.

Exclusion Criteria

• Have been previously treated with any drug that inhibits PI3K (For example: Idelalisib, Duvelisib, Buparlisib, Copanlisib, and Umbralisib).
• Have used any experimental drug therapy for Myelofibrosis or any other standard drug used for Myelofibrosis with the exception of Ruxolitinib, within 3 months of starting the study.
• Have any splenic radiation in the past 6 months.
• Have an active HBV, HCV, HIV, or other viral infection
• Be currently breastfeeding or pregnant.

Additional Info

• Eligible patients will be randomized to receive standard treatment with Ruxolitinib or the investigational combination of Ruxolitinib plus the study drug INCB050465.
• This study is double-blind which means neither you or the study physician will know which group you are randomized to receive.
• Bone Marrow Biopsy is required at screening and every 6 months while on trial.
• This is a crossover study so you may have the option of receiving the investigational combination (Ruxolitinib + INCB050465) after 6 months. Study participation will last up to 2.5years.
• Search NCT04551066 at https://clinicaltrials.gov website for more information.