A Phase 2 Study of CPI-0610 With and Without Ruxolitinib in Patients With Myelofibrosis
Age: 18 years - 66+
Healthy Subjects: No
Study Phase: Phase 1/Phase 2
Recruitment Status: Recruiting
Start Date: June 01, 2014
End Date: March 01, 2020
- Adult (aged ≥ 18 years)
- Phase 2 part: Patients with confirmed diagnosis of MF who meet all of the following criteria:
- Dynamic International Prognostic Scoring System (DIPSS) risk category of intermediate-1 or higher.
- ANC ≥ 1 x 10^9/L without the assistance of granulocyte growth factors
- Peripheral blood blast count <10%
- ECOG performance status ≤ 2.
- Adequate hematological, renal, hepatic, and coagulation laboratory assessments
- Patients must give written informed consent to participate in this study before the performance of any study-related procedure. For Arm 1 and 2 the following criteria should be considered:
- Palpable spleen ≥ 5 cm that is below the costal margin on physical examination OR RBC transfusion dependent (defined as an average of ≥2 units of RBC transfusions per month over the 12 weeks prior to enrollment)
- At least 2 symptoms measurable (score ≥ 1) using the Myelofibrosis Symptom Assessment Form Version 4.0 (MFSAF v4.0)
- Platelet count ≥ 75 x 10^9/L without the assistance of thrombopoietic factors or transfusions for at least 14 days
- Monotherapy Arm (Arm 1): Previously treated with a JAK inhibitor and be intolerant, resistant, refractory or lost response to the JAK inhibitor
- Combination Arm (Arm 2): Must have received single agent ruxolitinib and be on a stable dose for a minimum 8 weeks For Arm 3 (JAK inhibitors naïve) the following criteria should be considered:
- Platelet count ≥ 100 x 10^9/L without the assistance of thrombopoietic factors or transfusions
- Palpable spleen ≥ 5 cm that is below the costal margin on physical examination
- At least 2 symptoms measurable (score ≥ 3) or a total score of ≥ 10 using the MFSAF v4.0
- No prior treatment with JAKi allowed Exclusion Criteria
- Current known active or chronic infection with human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C.
- Impaired cardiac function or clinically significant cardiac diseases
- Patients with Child-Pugh Class B or C
- Impairment of gastrointestinal (GI) function or GI disease that could significantly alter the absorption of CPI-0610 and/or ruxolitinib, including any unresolved nausea, vomiting, or diarrhea that is CTCAE grade >1
- Prior treatment with a BET inhibitor.
- Pregnant or lactating women
- Any other concurrent severe and/or uncontrolled concomitant medical condition that could compromise participation in the study
- Patients unwilling or unable to comply with this study protocol.