Pacritinib Versus Best Available Therapy to Treat Myelofibrosis

• Status: Terminated
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase 3, randomized, controlled study to evaluate the safety and efficacy of oral pacritinib compared to Best Available Therapy (BAT) in patients with primary or secondary myelofibrosis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CTI BioPharma

Criteria

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