Study of CPI-0610 in Myelofibrosis (MF)

ID#: NCT04603495

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: November 19, 2020

End Date: September 01, 2023

Contact Information:
Debbie Johnson
617-714-0531
Summary:

A Phase 3, randomized, blinded study comparing CPI-0610 and ruxolitinib with placebo and ruxolitinib in myelofibrosis (MF) patients that have not been exposed previously to Janus kinase inhibitors (JAKi). CPI-0610 is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins. Evidence suggests that inhibition of both BET and JAK pathways can result in synergistic reduction of disease and overall improvement in the prognosis of MF.

Eligibility:



Inclusion Criteria:

- Aged ≥ 18 years

- Confirmed diagnosis of myelofibrosis (primary, post-polycythemia vera, or post essential thrombocythemia)

- Adequate hematologic, renal, and hepatic function

- Have at least 2 symptoms with an average score ≥ 3 or an average total score of ≥ 10 over the 7-day period prior to randomization using the MFSAF v4.0

- Prognostic risk-factor score of Intermediate-1 or higher per Dynamic International Prognostic Scoring System (DIPSS) scoring system

- Spleen volume of ≥ 450 cm^3

- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion Criteria:

- Splenectomy or splenic irradiation in the previous 6 months

- Chronic or active conditions and/or concomitant medication use that would prohibit treatment

- Had prior treatment with any JAKi or BET inhibitor for treatment of a myeloproliferative neoplasm