Pacritinib Versus Best Available Therapy to Treat Myelofibrosis

Stopped early · Phase 3

Conditions studied: Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis

In brief

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.

Key facts

Study ID

NCT01773187

Run by

CTI BioPharma

People needed

327

Starts

2013-01-01

Expected to finish

2016-04-01

Last updated by the study team

2020-09-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• CTI Investigational Site 10004 — Omaha, Nebraska, United States
• CTI Investigational Site 10001 — Morristown, New Jersey, United States
• CTI Investigational Site 10003 — Greenville, South Carolina, United States
• CTI Investigational Site 61006 — Box Hill, Australia
• CTI Investigational Site 61001 — Coffs Harbour, Australia
• CTI Investigational Site 61005 — Geelong, Australia
• CTI Investigational Site 61003 — Gosford, Australia
• CTI Investigational Site 61004 — Hobart, Australia
• CTI Investigational Site 61002 — Milton, Australia
• CTI Investigational Site 32002 — Antwerp, Belgium
• CTI Investigational Site 32003 — Antwerp, Belgium
• CTI Investigational Site 32001 — Bruges, Belgium
• CTI Investigational Site 32005 — Brussels, Belgium
• CTI Investigational Site 32004 — La Louvière, Belgium
• CTI Investigational Site 42003 — Brno, Czechia
• CTI Investigational Site 42001 — Olomouc, Czechia
• CTI Investigational Site 42002 — Pilsen, Czechia
• CTI Investigational Site 42004 — Prague, Czechia
• CTI Investigational Site 33005 — Amiens, France
• CTI Investigational Site 33006 — Caen, France
• CTI Investigational Site 33011 — Grenoble, France
• CTI Investigational Site 33012 — Lens, France
• CTI Investigational Site 33007 — Lille, France
• CTI Investigational Site 33001 — Nîmes, France
• CTI Investigational Site 10002 — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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