A Phase 2 Study With IPI-926 in Patients With Myelofibrosis

Inclusion Criteria

• •≥18 years of age at the time of signing the ICF.
• •Voluntarily sign an ICF.
• •Pathologically confirmed PMF or post ET/PV MF as per the WHO diagnostic criteria (note that it must include at least Grade 1 marrow fibrosis, see Appendix 3) with intermediate-1, intermediate -2, or high risk disease according to the IWG prognostic scoring system (see Appendix 4). If patients have low risk disease, then they must have symptomatic splenomegaly that is ≥ 10 cm below left costal margin by physical exam.
• •ECOG performance of 0-2.
• •Life expectancy of at least 3 months.
• •Recovery to Grade 1 or baseline of any toxicities due to prior systemic treatments, excluding alopecia.
• •If a woman, be of non-child bearing potential or, for women of child-bearing potential (WCBP) (defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally post-menopausal for at least 24 consecutive months for women ≤55 years; for women \>55 years 12 consecutive months), must have a negative serum or urine pregnancy test result within 2 weeks of first dose of study drug.
• •All WCBP and all sexually active male patients must agree to use adequate methods of birth control throughout the study. Adequate methods of contraception include use of oral contraceptives with an additional barrier method, double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam), Depo-Provera, partner vasectomy, and total abstinence.
• •Ability to adhere to the study visit schedule and all protocol requirements.