AzTrials
AzTrials

Primary MyelofibrosisPhase 3PACIFICANCT03165734

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

A Phase 3 study testing Pacritinib and Physician's Choice medications in people with Primary Myelofibrosis and Post-polycythemia Vera Myelofibrosis, run by Swedish Orphan Biovitrum at 207 sites in 24 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pacritinib and Physician's Choice medications
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
407 participants
Where
207 sitesin 24 countries
Study dates
26 Jun 2017to 13 Oct 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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
Show all 32Show fewer
  • Prior treatment with more than one JAK2 inhibitor
  • Prior treatment with with ruxolitinib, if BOTH of the following conditions are met:
  • 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.
  • Women who are pregnant or lactating
  • Concurrent enrollment in another interventional trial
  • Severe thrombocytopenia due to vitamin B12 deficiency, folate deficiency, or viral infection in the opinion of the investigator
  • Known hypersensitivity to pacritinib or any of the following inactive ingredients: microcrystalline cellulose, polyethylene glycol, and magnesium stearate; any contraindication to the "physician's choice" medicinal product selected by the investigator to be used as the comparator or to loperamide or equivalent antidiarrheal medication
  • Persons deprived of their liberty by a judicial or administrative decision
  • Persons subject to legal protection measures or unable to express their consent
  • Temporarily incapacitated persons

Trial locations and contacts

207 sites in 24 countries.

207 sites in 24 countries

United States42 sites

  • Michigan Medicine Hematology Clinic-Rogel Cancer Center

    Ann Arbor, Michigan, 48109

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • Saint Agnes Hospital

    Baltimore, Maryland, 21229

  • Johns Hopkins University

    Baltimore, Maryland, 21287

  • American Oncology Partners of Maryland, PA

    Bethesda, Maryland, 20817

  • Regional Cancer Care Associates LLC - CCBD Division

    Bethesda, Maryland, 20817

  • University of Alabama at Birmingham, (UAB) Hospital, Comprehensive Cancer Center

    Birmingham, Alabama, 35294

  • Rocky Mountain Cancer Centers (US Oncology/McKesson)

    Boulder, Colorado, 80303

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • The University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Cleveland Clinic

    Cleveland, Ohio, 44106

  • Maryland Oncology Hematology, PA- Columbia

    Columbia, Maryland, 21044

  • The James Cancer Hospital and Solove Research Institute

    Columbus, Ohio, 43210

  • City of Hope

    Duarte, California, 91010

  • Duke University Hospital

    Durham, North Carolina, 27710

  • Cancer and Hematology Centers of Western Michigan

    Grand Rapids, Michigan, 49546

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Comprehensive Cancer Centers of Nevada- Twain Office

    Las Vegas, Nevada, 89169

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • UCLA David Geffen School of Medicine

    Los Angeles, California, 90095

  • The Sarah Cannon Research Institute-Tennessee Oncology

    Nashville, Tennessee, 37203

  • Yale School of Medicine

    New Haven, Connecticut, 06510

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • Columbia University Medical Center

    New York, New York, 10017

  • Weill Cornell Medical College

    New York, New York, 10021

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Memorial Sloan -Kettering Cancer Center

    New York, New York, 10065

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Oregon Health and Science University

    Portland, Oregon, 97239-3098

  • University of Rochester

    Rochester, New York, 14642

  • University of Utah - Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Mays Cancer Center

    San Antonio, Texas, 78229

  • Texas Oncology- San Antonio

    San Antonio, Texas, 78240

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • Washington University School of Medicine-Siteman Cancer Center

    St Louis, Missouri, 63110

  • Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • George Washington University-Medical Faculty Associates

    Washington D.C., District of Columbia, 20037

  • Cleveland Clinic Florida

    Weston, Florida, 33331

  • University of Kansas Cancer Center and Medical Pavilion

    Westwood, Kansas, 66205

Other trials in United States

Italy17 sites

  • Cancer Institute "Giovanni Paolo II", IRCCS

    Bari

  • Polyclinic S. Orsola-Malpighi

    Bologna

  • ASST Spedali Civili Brescia, Hematology Unit

    Brescia

  • Azienda Ospedaliero-Universitaria Careggi

    Florence

  • Scientific Institute of Romagna for the Study and Treatment of Cancer (IRST), IRCCS

    Forlì

  • Maggiore Polyclinic Hospital, Fondazione IRCCS Ca' Granda

    Milan

  • ASST Monza - Ospedale San Gerardo

    Monza

  • University Hospital "Federico II"

    Naples

  • University Hospital "Maggiore della Carita" of Novara

    Novara

  • United Hospitals Villa Sofia Cervello

    Palermo

  • Polyclinic San Matteo, IRCCS

    Pavia

  • Hospital "Infermi" of Rimini

    Rimini

  • Umberto I Polyclinic of Rome

    Rome

  • University Polyclinic Foundation "Agostino Gemelli"

    Rome

  • City of Health and Science of Turin

    Turin

  • Santa Maria della Misericordia University Hospital of Udine

    Udine

  • ASST Sette Laghi Hospital

    Varese

Other trials in Italy

Brazil15 sites

  • Cetus Oncology Inc.

    Belo Horizonte, Minas Gerais

  • State University of Campinas (UNICAMP) - Hemocenter

    Campinas, São Paulo

  • Clinical Hospital of the Federal University of Parana (HC - UFPR)

    Curitiba, Paraná

  • Santa Catarina Health Research and Education Center (CEPEN)

    Florianópolis, Santa Catarina

  • Integrare Therapeutics

    Fortaleza, Ceará

  • Clinics Hospital, Federal University of Goias - (UFG)

    Goiânia, Goiás

  • Hospital Amaral Carvalho

    Jaú, São Paulo

  • Humane Clinic / Atena Research Institute

    Mossoró, Rio Grande do Norte

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul

  • Integrated Oncology Center of Rio Grande do Sul - Mother of God Hospital

    Porto Alegre, Rio Grande do Sul

  • Saint Lucas Hospital of Copacabana

    Rio de Janeiro, Rio de Janeiro

  • Hospital Sao Rafael

    Salvador, Estado de Bahia

  • Jewish Hospital Albert Einstein

    São Paulo, São Paulo

  • Samaritano Hospital

    São Paulo, São Paulo

  • Sao Paulo University Clinical Hospital

    São Paulo, São Paulo

Other trials in Brazil

India13 sites

  • St. John's Medical College Hospital

    Bengaluru

  • Postgraduate Institute of Medical Education and Research (PGIMER)

    Chandigarh, Chandigarh

  • All India Institute of Medical Sciences

    Dehradun, Uttarakhand

  • Max Super Speciality Hospital Saket (A Unit of Max Healthcare Institute Limited)

    Delhi

  • Fortis Memorial Research Institute(FMRI)

    Gurgaon, Haryana

  • Gauhati Medical College and Hospital

    Guwahati, Assam

  • Yashoda Hospitals

    Hyderabad, Telangana

  • Shri Ram Cancer Centre, Mahatma Gandhi Medical College & Hospital

    Jaipur, Rajasthan

  • Netaji Subhash Chandra Bose Cancer Research Institute

    Kolkata, West Bengal

  • Tata Medical Center

    Kolkata, West Bengal

  • Meenakshi Mission Hospital And Research Centre (MMHRC)

    Madurai, Tamil Nadu

  • Sahyadri Super Speciality Hospital

    Pune, Maharashtra

  • Nirmal Hospital Pvt Ltd

    Surat, Gujarat

Other trials in India

Poland12 sites

  • University Teaching Hospital in Bialystok

    Bialystok

  • University Clinical Center in Gdansk

    Gdansk

  • Andrzej Mielecki Independent Public Clinical Hospital of Medical University of Silesia in Katowice, Department of Hematology and Bone Marrow Transplantation

    Katowice

  • Pratia Oncology Katowice

    Katowice

  • University Hospital in Krakow

    Krakow

  • Nicolaus Copernicus Provincial Multispecialty Oncology and Traumatology Center in Lodz

    Lodz

  • Independent Public Teaching Hospital No.1 in Lublin, Department of Hematooncology, Bone Marrow Transplantation and Chemotherapy

    Lublin

  • Jedrzej Sniadecki Specialist Hospital in Nowy Sacz, Department of Hematology

    Nowy Sącz

  • Frederic Chopin Provincial Teaching Hospital No. 1 in Rzeszow, Department of Hematology,

    Rzeszów

  • Nasz Lekarz Medical Outpatient Clinics Slawomir Jeka

    Torun

  • Institute of Hematology and Transfusion Medicine, Teaching Department of Hematology

    Warsaw

  • Jan Mikulicz Radecki University Hospital in Wroclaw, Department and Clinic of Hematology, Blood Neoplasms and Bone Marrow Transplantation

    Wroclaw

Other trials in Poland

Japan10 sites

  • University of Yamanashi Hospital

    Chūō

  • Kyushu University Hospital

    Fukuoka

  • Fukushima Medical University Hospital

    Fukushima

  • Tohoku University Hospital

    Miyagi

  • University of Miyazaki Hospital

    Miyazaki

  • Juntendo University Hospital

    Tokyo

  • Nippon Medical School Hospital

    Tokyo

  • Tokyo Medical University Hospital

    Tokyo

  • Ehime University Hospital

    Tōon

  • Mie University Hospital

    Tsu

Other trials in Japan

Russia9 sites

  • City Clinical Hospital #40

    Moscow

  • City Clinical Hospital n.a. V.V. Veresaev of the Moscow City Health

    Moscow

  • S.P. Botkin City Clinical Hospital

    Moscow

  • Clinic UZI 4D, LLC

    Pyatigorsk

  • Research Institute of Hematology and Transfusiology

    Saint Petersburg

  • S.M. Kirov Military Medical Academy, Department and Clinic for Intermediate-Level Training in Internal Medicine, Hematology Division

    Saint Petersburg

  • V.A. Almazov North-West Federal Medical Research Center, Institute of Oncology and Hematology, Scientific Department of Clinical Oncology

    Saint Petersburg

  • Bashkiria State Medical University, Department of Internal Medicine

    Ufa

  • Volgograd Regional Clinical Oncology Center

    Volgograd

Other trials in Russia

Spain9 sites

  • Hospital Clínic de Barcelona

    Barcelona

  • Hospital del Mar

    Barcelona

  • University Hospital Vall d'Hebron

    Barcelona

  • Hospital Universitario Ramón y Cajal

    Madrid

  • University Hospital 12 de Octubre, Department of Hematology

    Madrid

  • Morales Meseguer University General Hospital, Department of Hematology and Hemotherapy

    Murcia

  • University Clinical Hospital of Salamanca, Department of Hematology

    Salamanca

  • University Hospital Virgen del Rocio (HUVR)

    Seville

  • University Clinical Hospital of Valencia, Department of Hematology and Medical Oncology

    Valencia

Other trials in Spain

Ukraine8 sites

  • Cherkasy Regional Oncology Dispensary of Cherkasy Oblast Council, Regional Treatment and Diagnostic Hematology Center, Department of Hematology

    Cherkasy

  • City Clinical Hospital #4" under Dnipro City Council

    Dnipro

  • Communal Non-profit enterprise "Regional Center of Oncology", Department of Hematology

    Kharkiv

  • Kyiv City Clinical Hospital #9, Hematology Department #1

    Kyiv

  • Kyiv Regional Oncology Center, Department of Hematology,

    Kyiv

  • Limited Liability Company "City Doctor"

    Kyiv

  • Institute of Blood Pathology and Transfusion Medicine, Department of Hematology

    Lviv

  • Poltava M.V. Sklifosovskyi Regional Clinical Hospital under Poltava Regional Council, Department of Hematology

    Poltava

Other trials in Ukraine

Canada7 sites

  • Tom Baker Cancer Center, Internal Medicine/Hematology

    Calgary, Alberta

  • University of Alberta

    Edmonton, Alberta

  • Nova Scotia Health Authority, Centre for Clinical Research

    Halifax, Nova Scotia

  • Jewish General Hospital; Clinical Research Unit

    Montreal, Quebec

  • Eastern Regional Health Authority

    St. John's, Newfoundland and Labrador

  • Princess Margaret Cancer Centre

    Toronto, Ontario

  • Providence Hematology - Vancouver

    Vancouver, British Columbia

Other trials in Canada

France7 sites

  • CHU Hôpital Amiens Sud

    Amiens, France, 80054

  • La Conception Hospital

    Marseille

  • CHU de Nimes - Hopital Universitaire Caremeau

    Nîmes, France, 30900

  • Hôpital Saint-Louis

    Paris

  • CHU Hopitaux de Bordeaux - Hôpital Haut-Lévêque

    Pessac, 33604

  • Centre Hospitalier Lyon-Sud

    Pierre-Bénite

  • University Hospital Center of Poitiers

    Poitiers

Other trials in France

Kazakhstan7 sites

  • Aktobe Medical Center, Department of Hematology

    Aktobe

  • City Clinical Hospital #7, Hematology Department

    Almaty

  • Center for Hematology

    Astana

  • National Research Oncology, Oncohematology Center

    Astana

  • Hematology Center

    Karaganda

  • City Oncological Center

    Shymkent

  • Center for Hematology

    Ust-Kamenogorsk

Other trials in Kazakhstan

United Kingdom7 sites

  • Beatson West of Scotland Cancer Centre

    Glasgow, United Kingdom, G12 0ZD

  • Gloucestershire Royal Hospital

    Gloucester

  • Barts Health NHS Trust - The Royal London Hospital

    London, United Kingdom, E1 2ES

  • Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital

    London

  • Imperial College Healthcare NHS Trust - Hammersmith Hospital

    London

  • Oxford University Hospitals NHS Trust - Churchill Hospital

    Oxford

  • Royal Hallamshire Hospital, Department of Hematology

    Sheffield, South Yorkshire

Other trials in United Kingdom

South Korea6 sites

  • Pusan National University Hospital

    Busan

  • Kyungpook National University Hospital

    Daegu

  • Severance Hospital

    Seoul, South Korea, 3722

  • Samsung Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

  • The Catholic University of Korea, St. Mary's Hospital

    Seoul

Other trials in South Korea

Bulgaria5 sites

  • University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski"

    Pleven

  • University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv

    Plovdiv

  • Multiprofile Hospital for Active Treatment - Sofia, part of Military Medical Academy

    Sofia

  • Specialized Hospital for Active Treatment of Hematological Diseases

    Sofia

  • Multiprofile Hospital for Active Treatment "Sveta Marina"

    Varna

Other trials in Bulgaria

Georgia5 sites

  • JSC K. Eristavi National Center For Experimental and Clinical Surgery

    Tbilisi

  • LTD M.Zodelava's Hematology Center, Department of Hematology

    Tbilisi

  • LTD S.Khechinashvili University Hospital

    Tbilisi

  • Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LTD

    Tbilisi

  • Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC

    Tbilisi

Other trials in Georgia

Hungary5 sites

  • Semmelweis University SE ÁOK I. sz. Belgyógyászati Klinika

    Budapest

  • University of Debrecen Clinical Center (Debreceni Egyetem Klinikai Központ)

    Debrecen

  • Somogy Megyei Kaposi Mór Oktató Kórház

    Kaposvár

  • Szabolcs-Szatmar-Bereg County Hospitals and University Teaching Hospital, Department of Hematology

    Nyíregyháza

  • Fejer County St. Gyorgy University Teaching Hospital, Department of Internal Medicine I

    Székesfehérvár

Other trials in Hungary

Israel5 sites

  • Lady Davis Carmel Medical Center, Department of Hematology,

    Haifa

  • Hadassah Medical Center, Department of Hematology,

    Jerusalem

  • Meir Medical Center, Hematology Institute and Blood Bank

    Kfar Saba

  • Rabin Medical Center, Clinic for Myeloproliferative Disorders

    Petah Tikva

  • The Tel Aviv Sourasky Medical Center, Department of Internal Medicine

    Tel Aviv

Other trials in Israel

Czechia4 sites

  • University Hospital Brno

    Brno

  • University Hospital Olomouc

    Olomouc

  • University Hospital Plzen

    Pilsen

  • University Hospital Kralovske Vinohrady, Clinic of Internal Hematology

    Prague

Other trials in Czechia

Romania4 sites

  • Onco Card Srl

    Brasov

  • Coltea Clinical Hospital

    Bucharest

  • Fundeni Clinical Institute

    Bucharest

  • Prof. Dr. Ion Chiricuta" Institute of Oncology

    Cluj-Napoca

Other trials in Romania

Australia3 sites

  • Alfred Hospital, Malignant Hematology and Stem Cell Transplantation Service

    Melbourne, Victoria

  • The Perth Blood Institute

    Perth, Western Australia

  • Westmead Hospital

    Sydney, New South Wales

Other trials in Australia

Belarus3 sites

  • Grodno University Hospital

    Grodno

  • Republican Research Center for Radiation Medicine and Human Ecology

    Homyel

  • Minsk Scientific and Practical Center of Surgery, Transplantology and Hematology

    Minsk

Other trials in Belarus

Bosnia and Herzegovina2 sites

  • University Clinical Centre of the Republic of Srpska

    Banja Luka

  • University Clinical Center of Sarajevo

    Sarajevo

Other trials in Bosnia and Herzegovina

Serbia2 sites

  • Clinical Center of Serbia, Clinic of Hematology

    Belgrade

  • Clinical Center of Vojvodina, Clinic of Hematology

    Novi Sad

Other trials in Serbia

About this study

Official title: A Randomized, Controlled Phase 3 Study of Pacritinib Versus Physician's Choice in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis With Severe Thrombocytopenia (Platelet Count <50,000/μL)(PACIFICA)

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

Read the detailed description

The study is a randomized, controlled phase 3 study comparing the efficacy of pacritinib with P/C therapy in patients with PMF, PPV-MF, or PET-MF (Dynamic International Prognostic Scoring System [DIPSS] risk score of Intermediate-1 to High-Risk), who have had had no or limited exposure to any JAK2 inhibitor or are JAK2 inhibitor-naive, and who have severe thrombocytopenia (platelet count <50,000/µL). This study was designed to use the pacritinib 200 mg BID dose, which was determined to be the optimal dose based on dose- and exposure-response analyses conducted using all available data, including the dosing data from the previous portion of this study. Patients will be randomized 2:1 to receive pacritinib 200 mg BID or the P/C therapy (limited to single drugs from the following list: corticosteroids, hydroxyurea, danazol, or low-dose ruxolitinib). The proposed P/C regimen for a patient must be selected prior to randomization. Randomization will be stratified by prior JAK2 inhibitor therapy (yes/no) and P/C therapy selected prior to randomization. Prior JAK2 inhibitor therapy will be defined as any duration of treatment with a JAK2 inhibitor, such as ruxolitinib, fedratinib, or momelotinib. To be eligible, patients are not allowed to have been treated with more than one JAK2 inhibitor. Assigned treatment will continue until the patient experiences progressive disease or intolerable AEs, withdraws consent, or initiates new MF-directed therapy. No study treatment crossover will be allowed at any time. All patients should complete all visit procedures through Week 24, including patients who stop treatment or have protocol-defined progressive disease prior to Week 24, unless the patient withdraws consent for study procedures, dies, undergoes splenic irradiation or splenectomy, initiates any non-protocol-directed anti-MF treatment, or the study is terminated. In addition to the above, patients will be considered to have discontinued treatment if pacritinib or P/C therapy is held for >28 consecutive days due to treatment toxicity, or if treatment is discontinued for lack of efficacy, or at the request of the principal investigator or the patient. Following the Week 24 assessment, patients who are benefiting from therapy will be allowed to continue receiving the assigned treatment (pacritinib or P/C) until the patient experiences progressive disease, intolerable AEs, withdraws consent, or initiates new MF-directed therapy. All randomized patients will be followed for survival for 2.5 years from the date of randomization unless consent for follow-up is withdrawn.

Being tested
Pacritinib, Physician's Choice medications
Keywords
myelofibrosis, pacritinib, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, Ruxolitinib, Bone Marrow Disease, Hematologic Diseases, Blood Platelet Disorders, Hemorrhagic Disorders, Splenomegaly, Anemia, Spleen volume, Spleen
Medical subject headings
Primary Myelofibrosis, Bone Marrow Diseases, Hematologic Diseases, Blood Platelet Disorders, Hemorrhagic Disorders, Splenomegaly, Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PacritinibDrug

    Oral administration. Supplied in capsules containing 100 mg (as the free base) in red cap/gray body size 0 opaque hard gelatin capsules. The inactive ingredients are microcrystalline cellulose, magnesium stearate, and polyethylene glycol 8000. Each capsule contains 146 mg of pacritinib citrate, which is equivalent to 100 mg pacritinib free base

  • Physician's Choice medicationsDrug

    Also called corticosteroids, hydroxyurea, danazol, low-dose ruxolitinib

    Physician's Choice medications will be selected and administered according to the investigator's judgement. Investigators can select individual P/C agents but cannot combine agents or give them sequentially.

Study groups in NCT03165734
Study groupRoleWhat they receive
Pacritinib 200 mg BIDExperimentalTo receive pacritinib 200 mg twice daily (BID) orally, at the same time of day, with or without food
Receives: Drug: Pacritinib
Physician's Choice (P/C) therapyActive comparatorThe Physician's Choice (P/C) therapy (limited to single drugs from the following list: corticosteroids, hydroxyurea, danazol, or low-dose ruxolitinib). The proposed P/C regimen for a patient must be selected prior to randomization.
Receives: Drug: Physician's Choice medications

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Spleen volume

    To compare the efficacy of pacritinib with that of physician's choice (P/C) therapy, as assessed by the proportion of patients achieving a ≥35% spleen volume reduction (SVR) as measured by magnetic resonance imaging (MRI, preferred) or computed tomography (CT) scans

    Measured: From baseline at 24 weeks

  2. Total Symptom Score (TSS) (excluding tiredness)

    To compare the efficacy of pacritinib compared to P/C therapy, as assessed by the proportion of patients achieving a ≥50% reduction in Total Symptom Score (TSS). The TSS is the sum of the individual symptom scores for tiredness, early satiety, abdominal discomfort, night sweats, pruritus, bone pain, and pain under ribs on the left side. Symptoms are ranked 0 (absent) to 10 (worst imaginable)

    Measured: From baseline at Week 24

Secondary outcomes (3)

  1. Overall Survival (OS)

    To compare the overall survival (OS) of patients treated with pacritinib versus those treated with P/C

    Measured: until 2.5 years after the date of randomization

  2. Patient Global Impression of Change (PGIC) assessed at Week 24

    To compare the percentage of patients who self-assess as "very much improved" or "much improved" as measured by the Patient Global Impression of Change (PGIC) in patients treated with pacritinib versus those treated with P/C

    Measured: End of Week 12 to 2 years following Week 24 visit

  3. To compare the safety of pacritinib versus P/C therapy

    Safety will be assessed based on the incidence and severity (according to the Common Terminology Criteria for Adverse Events) of treatment emergent adverse events from the time of randomization until 30 days after completion of treatment with pacritinib and/or physician's choice therapy.

    Measured: Randomization through 30 after last treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2017
  2. Study start26 Jun 2017
  3. Primary completion5 Oct 2026 (estimated)
  4. Study completion13 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
407 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03165734
Sponsor's protocol ID
PAC203/PAC303
Other IDs
PAC303
Acronym
PACIFICA
Status last verified
Oct 2025
First submitted
17 May 2017
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gerds AT, Savona MR, Scott BL, Talpaz M, Egyed M, Harrison CN, Yacoub A, Vannucchi A, Mead AJ, Kiladjian JJ, O'Sullivan J, Garcia-Gutierrez V, Bose P, Rampal RK, Miller CB, Palmer J, Oh ST, Buckley SA, Mould DR, Ito K, Tyavanagimatt S, Smith JA, Roman-Torres K, Devineni S, Craig AR, Mascarenhas JO. Determining the recommended dose of pacritinib: results from the PAC203 dose-finding trial in advanced myelofibrosis. Blood Adv. 2020 Nov 24;4(22):5825-5835. doi: 10.1182/bloodadvances.2020003314.

    PubMed 33232476

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pacritinib and Physician's Choice medications in people with Primary Myelofibrosis and Post-polycythemia Vera Myelofibrosis, run by Swedish Orphan Biovitrum at 207 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 207 sites in United States, Italy, Brazil, India, Poland and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Spleen volume (time frame: From baseline at 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03165734, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.

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