Study of CPI-0610 in Myelofibrosis (MF)

a study on Myelofibrosis Primary Myelofibrosis Post-polycythemia Vera Myelofibrosis Post-essential Thrombocythemia Myelofibrosis

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

A Phase 3, Randomized, Double-blind, Active-Control Study of CPI-0610 and Ruxolitinib vs. Placebo and Ruxolitinib in JAKi Treatment Naive MF Patients

Keywords

Myelofibrosis Primary Myelofibrosis Post-polycythemia Vera Myelofibrosis Post-essential Thrombocythemia Myelofibrosis Pelabresib Ruxolitinib Polycythemia Vera Polycythemia Thrombocytosis Thrombocythemia, Essential CPI-0610 CPI-0610 + ruxolitinib

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 cm3

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

You CAN'T join if...

  • 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

Locations

  • UC San Diego Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • Mays Cancer Center at UT Health San Antonio MD Anderson accepting new patients
    San Antonio Texas 78229 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Constellation Pharmaceuticals
ID
NCT04603495
Phase
Phase 3
Study Type
Interventional
Last Updated
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