A Randomized Controlled Phase 3 Study of Oral Pacritinib Versus Best Available Therapy in Patients With Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis

Location:

Phoenix/Scottsdale, Ariz.

Trial status:

Open for Enrollment

Why is this study being done?

The primary hypothesis of the study is that treatment with pacritinib results in a greater proportion of patients achieving ≥ 35% reduction in spleen volume from baseline to Week 24 than treatment with BAT.

Who is eligible to participate?

Inclusion Criteria: - Intermediate -1 or -2 or high-risk Myelofibrosis (per Passamonti et al 2010) - Palpable splenomegaly ≥ 5 cm on physical examination - Total Symptom Score >13 on the MPN-SAF TSS 2.0, not including the inactivity question - Patients who are platelet or red blood cell transfusion-dependent are eligible - Adequate white blood cell counts (with low blast counts), liver function, and renal function - No spleen radiation therapy for 6-12 months - Last therapy for myelofibrosis was 2-4 weeks ago, including any erythropoietic or thrombopoietic agent - Not pregnant, not lactating, and agree to use effective birth control Exclusion Criteria: - Prior treatment with a JAK2 inhibitor - History of (or plans to undergo) spleen removal surgery or allogeneic stem cell transplant - Ongoing gastrointestinal medical condition such as Crohn's disease, Inflammatory bowel disease, chronic diarrhea, or constipation - Cardiovascular disease, including recent history or currently clinically symptomatic and uncontrolled: congestive heart failure, arrhythmia, angina, QTc prolongation or other QTc risk factors, myocardial infarction - Other malignancy within last 3 years other than certain limited skin, cervical, prostate, breast, or bladder cancers - Other ongoing, uncontrolled illnesses (including HIV infection and active hepatitis A, B, or C), psychiatric disorder, or social situation that would prevent good care on this study - Life expectancy < 6 months

Last updated:

6/30/2014

NCT ID:

NCT01773187

IRB Number:

13-000658