A Phase 2 Study of CPI-0610 With and Without Ruxolitinib in Patients With Myelofibrosis

Official Title

A Phase 1/2 Study of CPI-0610, a Small Molecule Inhibitor of BET Proteins: Phase 1 (in Patients With Hematological Malignancies) and Phase 2 (Dose Expansion of CPI-0610 With and Without Ruxolitinib in Patients With Myelofibrosis)

Summary:

Phase 1 Part (Complete): Open-label, sequential dose escalation study of CPI-0610 in patients with previously treated Acute Leukemia, Myelodysplastic Syndrome, Myelodysplastic/Myeloproliferative Neoplasms, and Myelofibrosis. Phase 2 Part: Open-label study of CPI-0610 with and without Ruxolitinib in patients with Myelofibrosis. CPI-0610 is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins.

Trial Description

Primary Outcome:

  • Phase 2 Part: Evaluate spleen response
  • Phase 2 Part: Evaluate the RBC (Red Blood Cell) transfusion independence rate
Secondary Outcome:
  • Phase 2 Part: Evaluate the duration of spleen response by imaging
  • Phase 2 Part: Evaluate response category rate
  • Phase 2 Part: Evaluate the change in patient reported outcomes
  • Phase 2 Part: Evaluate the rate of RBC transfusion and the RBC transfusion dependence rate
  • Phase 2 Part: Pharmacokinetic parameters of CPI-0610 and ruxolitinib: AUC and Cmax

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society