This trial is active, not recruiting.

Conditions primary myelofibrosis, post-polycythemia vera myelofibrosis, post-essential thrombocythemia myelofibrosis
Treatments pacritinib, best available therapy
Phase phase 3
Targets JAK, JAK2
Sponsor CTI BioPharma
Start date December 2012
End date August 2014
Trial size 327 participants
Trial identifier NCT01773187, PERSIST-1 (PAC325)


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Pacritinib 400 mg taken orally, once daily
(Active Comparator)
BAT includes any physician-selected treatment for PMF, PPV-MF, or PET-MF with the exclusion of JAK inhibitors (inhibitors of Janus kinases). For example, BAT may include hydroxyurea, glucocorticoids, erythropoietic agents, immunomodulatory agents, mercaptopurine, danazol, interferons, cytarabine, melphalan, or other agents.
best available therapy

Primary Outcomes

time frame: Baseline to Week 24

Secondary Outcomes

Symptomatic Efficacy
time frame: Baseline to week 24

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by CTI BioPharma.