A Phase 3 Study of Pacritinib in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis

Running, not enrolling · Phase 3

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

In brief

This study (study ID PAC203 North America; PAC303 ex-North America) is evaluating 200 mg BID of pacritinib compared to physician's choice (P/C) therapy in patients with MF and severe thrombocytopenia (platelet count \<50,000/μL). Approximately 399 patients in total will be enrolled, randomized 2:1 to either pacritinib (approximately 266 patients) or to P/C therapy (approximately 133 patients) Condition or disease: Primary Myelofibrosis/Post-Polycythemia Vera Myelofibrosis/ Post-essential Thrombocythemia Myelofibrosis Intervention/treatment: Drug-Pacritinib

Key facts

Study ID

NCT03165734

Run by

Swedish Orphan Biovitrum

People needed

407

Starts

2017-06-26

Expected to finish

2028-10-13

Last updated by the study team

2026-04-30

Who can join

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

You may not qualify if…

• Life expectancy <6 months
• Completed allogeneic stem cell transplant or are eligible for and willing to complete other approved available therapy including allogeneic stem cell transplant
• History of splenectomy or planning to undergo splenectomy
• Splenic irradiation within the last 6 months
• Previously treated with pacritinib
• Treatment with any MF-directed therapy within 14 days prior to treatment Day 1
• Prior treatment with more than one JAK2 inhibitor
• Prior treatment with with ruxolitinib, if BOTH of the following conditions are met:
• i. exposure to higher-dose ruxolitinib (>10 mg daily) within 120 days prior to treatment Day 1 AND ii. total duration of treatment with higher-dose ruxolitinib (>10 mg daily) was >90 days, from first to last exposure (i.e., this 90-day period starts on the date of first administration of ruxolitinib at a total daily dose of >10 mg and continues for 90 calendar days, regardless of whether higher-dose ruxolitinib is administered continuously or intermittently).
• Prior treatment with any JAK2 inhibitor other than ruxolitinib, irrespective of dose, with a duration of >90 days. The 90-day period starts on the date of first administration of JAK2 inhibitor therapy and continues for 90 calendar days, regardless of whether therapy is administered continuously or intermittently.
• Treatment with an experimental therapy, including MF-directed experimental therapies within 28 days prior to treatment Day 1
• Systemic treatment with a strong cytochrome P450 3A4 (CYP 3A4) inhibitor or a strong CYP 3A4 inducer within 14 days prior to treatment Day 1. Shorter washout periods may be permitted with approval of the Medical Monitor, provided that the washout period is at least five half-lives of the drug prior to treatment Day 1
• Significant recent bleeding history defined as National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grade ≥2 within 3 months prior to treatment Day 1, unless precipitated by an inciting event (eg, surgery, trauma, or injury)
• Systemic treatment with medications that increase the risk of bleeding, including anticoagulants, antiplatelet agents (except for aspirin dosages of ≤100 mg per day),and daily use of cyclooxygenase-1 (COX-1) inhibiting non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days prior to treatment Day 1. Treatment with systemic anti-vascular endothelial growth factor (anti-VEGF) agents within 28 days prior to treatment Day 1.
• Systemic treatment with medications that can prolong the QT interval within 14 days prior to treatment Day 1. Shorter washout periods may be permitted with approval of the Medical Monitor, provided that the washout period is at least five half-lives of the drug prior to treatment Day 1
• Any history of CTCAE grade ≥2 non-dysrhythmia cardiac conditions within 6 months prior to treatment Day 1. Patients with asymptomatic grade 2 non-dysrhythmia cardiovascular conditions may be considered for inclusion, with the approval of the Medical Monitor, if stable and unlikely to affect patient safety.
• Any history of CTCAE grade ≥2 cardiac dysrhythmias within 6 months prior to treatment Day 1. Patients with non-corrected QT interval CTCAE grade 2 cardiac dysrhythmias may be considered for inclusion, with the approval of the Medical Monitor, if the dysrhythmias are stable, asymptomatic, and unlikely to affect patient safety.
• QT corrected by the Fridericia method (QTcF) prolongation >450 ms or other factors that increase the risk for QT interval prolongation (eg, hypokalemia [defined as serum potassium <3.0 mEq/L that is persistent and refractory to correction], or history of long QT interval syndrome).
• New York Heart Association Class II, III, or IV congestive heart failure
• Any active gastrointestinal or metabolic condition that could interfere with absorption of oral medication
• Active or uncontrolled inflammatory or chronic functional bowel disorder such as Crohn's Disease, inflammatory bowel disease, chronic diarrhea, or chronic constipation
• Other malignancy within 3 years prior to treatment Day 1. The following patients may be eligible despite having had a malignancy within the prior 3 years: patients with curatively treated squamous or basal cell carcinoma of the skin; patients with curatively treated non-invasive cancers; patients with organ-confined prostate cancer with prostate specific antigen (PSA) <20 ng/mL and National Comprehensive Cancer Network risk of Very Low, Low, or Favorable Intermediate; and patients with curatively treated non-metastatic prostate cancer with negative PSA.
• Uncontrolled intercurrent illness, including, but not limited to, ongoing active infection, psychiatric illness, or social situation that, in the judgment of the treating physician, would limit compliance with study requirements
• Known seropositivity for human immunodeficiency (HIV) virus. For patients in Czech Republic, France and Italy only: testing for HIV is required during Screening.
• Known active hepatitis A, B, or C virus infection. For patients in Czech Republic, France and Italy only: testing for hepatitis B and C is required during Screening.

Where it is running

• Mayo Clinic Hospital — Phoenix, Arizona, United States
• City of Hope — Duarte, California, United States
• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
• UCLA David Geffen School of Medicine — Los Angeles, California, United States
• University of Colorado Cancer Center — Aurora, Colorado, United States
• Rocky Mountain Cancer Centers (US Oncology/McKesson) — Boulder, Colorado, United States
• Yale School of Medicine — New Haven, Connecticut, United States
• Georgetown University Hospital — Washington D.C., District of Columbia, United States
• George Washington University-Medical Faculty Associates — Washington D.C., District of Columbia, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• The University of Chicago Medical Center — Chicago, Illinois, United States
• University of Kansas Cancer Center and Medical Pavilion — Westwood, Kansas, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• Saint Agnes Hospital — Baltimore, Maryland, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• American Oncology Partners of Maryland, PA — Bethesda, Maryland, United States
• Regional Cancer Care Associates LLC - CCBD Division — Bethesda, Maryland, United States
• Maryland Oncology Hematology, PA- Columbia — Columbia, Maryland, United States
• Michigan Medicine Hematology Clinic-Rogel Cancer Center — Ann Arbor, Michigan, United States
• Cancer and Hematology Centers of Western Michigan — Grand Rapids, Michigan, United States
• Washington University School of Medicine-Siteman Cancer Center — St Louis, Missouri, United States
• Comprehensive Cancer Centers of Nevada- Twain Office — Las Vegas, Nevada, United States
• University of Alabama at Birmingham, (UAB) Hospital, Comprehensive Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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