Pacritinib Versus Best Available Therapy to Treat Patients With Myelofibrosis and Thrombocytopenia

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 thrombocytopenia and primary or secondary myelofibrosis.

Key facts

Study ID

NCT02055781

Run by

CTI BioPharma

People needed

311

Starts

2014-02-01

Expected to finish

2016-04-01

Last updated by the study team

2021-11-18

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)
• Thrombocytopenia (platelet count ≤ 100,000/µL) at any time after signing informed consent
• 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
• At least 6 months from prior splenic irradiation
• At least 1-4 weeks since prior myelofibrosis therapy, including any erythropoietic or thrombopoietic agent
• Not pregnant, not lactating, and agree to use effective birth control
• Able and willing to undergo frequent MRI or CT assessments and complete symptom assessments using a patient-reported outcome instrument

You may not qualify if…

• Prior treatment with more than 2 JAK2 inhibitors or with pacritinib
• There is no maximum cumulative prior JAK2 inhibitor treatment
• 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
• Active bleeding that requires hospitalization during the screening period
• 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

• Arizona Clinical Research Center — Tucson, Arizona, United States
• City of Hope — Duarte, California, United States
• Moores Cancer Centre — La Jolla, California, United States
• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Stanford Cancer Center — Stanford, California, United States
• Rocky Mountain Cancer Center — Boulder, Colorado, United States
• George Washington University- Medical Faculty Associates — Washington D.C., District of Columbia, United States
• SCRI- Florida Cancer Specialists South Region — Fort Myers, Florida, United States
• SCRI - Florida Cancer Specialists North Region — St. Petersburg, Florida, United States
• H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• Carle Cancer Center — Urbana, Illinois, United States
• Indiana University Goshen Cancer Centre — Goshen, Indiana, United States
• Investigative Clinical Research of Indiana — Indianapolis, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Siouxland Hematology-Oncology Associates, L.L.P (SHOA) — Sioux City, Iowa, United States
• Norton Cancer Institute, Suburban — Louisville, Kentucky, United States
• St Joseph Mercy Hospital — Ann Arbor, Michigan, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Providence Cancer Institute — Southfield, Michigan, United States
• Washington University School of Medicine Division of Oncology — St Louis, Missouri, United States
• Nebraska Hematology-Oncology, P.C. — Lincoln, Nebraska, United States
• Hackensack University — Hackensack, New Jersey, United States
• Mayo Clinic Arizona — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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