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

April 27, 2026 updated by: Swedish Orphan Biovitrum

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
407

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia
        • Westmead Hospital
    • Victoria
      • Melbourne, Victoria, Australia
        • Alfred Hospital, Malignant Hematology and Stem Cell Transplantation Service
    • Western Australia
      • Perth, Western Australia, Australia
        • The Perth Blood Institute
  • Belarus
      • Grodno, Belarus
        • Grodno University Hospital
      • Homyel, Belarus
        • Republican Research Center for Radiation Medicine and Human Ecology
      • Minsk, Belarus
        • Minsk Scientific and Practical Center of Surgery, Transplantology and Hematology
  • Bosnia and Herzegovina
      • Banja Luka, Bosnia and Herzegovina
        • University Clinical Centre of the Republic of Srpska
      • Sarajevo, Bosnia and Herzegovina
        • University Clinical Center of Sarajevo
  • Brazil
    • Ceará
      • Fortaleza, Ceará, Brazil
        • Integrare Therapeutics
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil
        • Hospital Sao Rafael
    • Goiás
      • Goiânia, Goiás, Brazil
        • Clinics Hospital, Federal University of Goias - (UFG)
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil
        • Cetus Oncology Inc.
    • Paraná
      • Curitiba, Paraná, Brazil
        • Clinical Hospital of the Federal University of Parana (HC - UFPR)
    • Rio Grande do Norte
      • Mossoró, Rio Grande do Norte, Brazil
        • Humane Clinic / Atena Research Institute
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil
        • Hospital Moinhos de Vento
      • Porto Alegre, Rio Grande do Sul, Brazil
        • Integrated Oncology Center of Rio Grande do Sul - Mother of God Hospital
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brazil
        • Saint Lucas Hospital of Copacabana
    • Santa Catarina
      • Florianópolis, Santa Catarina, Brazil
        • Santa Catarina Health Research and Education Center (CEPEN)
    • São Paulo
      • Campinas, São Paulo, Brazil
        • State University of Campinas (UNICAMP) - Hemocenter
      • Jaú, São Paulo, Brazil
        • Hospital Amaral Carvalho
      • São Paulo, São Paulo, Brazil
        • Jewish Hospital Albert Einstein
      • São Paulo, São Paulo, Brazil
        • Samaritano Hospital
      • São Paulo, São Paulo, Brazil
        • Sao Paulo University Clinical Hospital
  • Bulgaria
      • Pleven, Bulgaria
        • University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski"
      • Plovdiv, Bulgaria
        • University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv
      • Sofia, Bulgaria
        • Specialized Hospital for Active Treatment of Hematological Diseases
      • Sofia, Bulgaria
        • Multiprofile Hospital for Active Treatment - Sofia, part of Military Medical Academy
      • Varna, Bulgaria
        • Multiprofile Hospital for Active Treatment "Sveta Marina"
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Tom Baker Cancer Center, Internal Medicine/Hematology
      • Edmonton, Alberta, Canada
        • University of Alberta
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Providence Hematology - Vancouver
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada
        • Eastern Regional Health Authority
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Nova Scotia Health Authority, Centre for Clinical Research
    • Ontario
      • Toronto, Ontario, Canada
        • Princess Margaret Cancer Centre
    • Quebec
      • Montreal, Quebec, Canada
        • Jewish General Hospital; Clinical Research Unit
  • Czechia
      • Brno, Czechia
        • University Hospital Brno
      • Olomouc, Czechia
        • University Hospital Olomouc
      • Pilsen, Czechia
        • University Hospital Plzen
      • Prague, Czechia
        • University Hospital Kralovske Vinohrady, Clinic of Internal Hematology
  • France
      • Marseille, France
        • La Conception Hospital
      • Paris, France
        • Hopital Saint-Louis
      • Pessac, France, 33604
        • CHU Hopitaux de Bordeaux - Hôpital Haut-Lévêque
      • Pierre-Bénite, France
        • Centre Hospitalier Lyon-Sud
      • Poitiers, France
        • University Hospital Center of Poitiers
    • France
      • Amiens, France, France, 80054
        • CHU Hôpital Amiens Sud
      • Nîmes, France, France, 30900
        • CHU de Nimes - Hopital Universitaire Caremeau
  • Georgia
      • Tbilisi, Georgia
        • LTD S.Khechinashvili University Hospital
      • Tbilisi, Georgia
        • JSC K. Eristavi National Center For Experimental and Clinical Surgery
      • Tbilisi, Georgia
        • LTD M.Zodelava's Hematology Center, Department of Hematology
      • Tbilisi, Georgia
        • Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LTD
      • Tbilisi, Georgia
        • Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC
  • Hungary
      • Budapest, Hungary
        • Semmelweis University SE ÁOK I. sz. Belgyógyászati Klinika
      • Debrecen, Hungary
        • University of Debrecen Clinical Center (Debreceni Egyetem Klinikai Központ)
      • Kaposvár, Hungary
        • Somogy Megyei Kaposi Mor Oktato Korhaz
      • Nyíregyháza, Hungary
        • Szabolcs-Szatmar-Bereg County Hospitals and University Teaching Hospital, Department of Hematology
      • Székesfehérvár, Hungary
        • Fejer County St. Gyorgy University Teaching Hospital, Department of Internal Medicine I
  • India
      • Bengaluru, India
        • St. John's Medical College Hospital
      • Delhi, India
        • Max Super Speciality Hospital Saket (A Unit of Max Healthcare Institute Limited)
    • Assam
      • Guwahati, Assam, India
        • Gauhati Medical College and Hospital
    • Chandigarh
      • Chandigarh, Chandigarh, India
        • Postgraduate Institute of Medical Education and Research (PGIMER)
    • Gujarat
      • Surat, Gujarat, India
        • Nirmal Hospital Pvt Ltd
    • Haryana
      • Gurgaon, Haryana, India
        • Fortis Memorial Research Institute(FMRI)
    • Maharashtra
      • Pune, Maharashtra, India
        • Sahyadri Super Speciality Hospital
    • Rajasthan
      • Jaipur, Rajasthan, India
        • Shri Ram Cancer Centre, Mahatma Gandhi Medical College & Hospital
    • Tamil Nadu
      • Madurai, Tamil Nadu, India
        • Meenakshi Mission Hospital And Research Centre (MMHRC)
    • Telangana
      • Hyderabad, Telangana, India
        • Yashoda Hospitals
    • Uttarakhand
      • Dehradun, Uttarakhand, India
        • All India Institute of Medical Sciences
    • West Bengal
      • Kolkata, West Bengal, India
        • Netaji Subhash Chandra Bose Cancer Research Institute
      • Kolkata, West Bengal, India
        • Tata Medical Center
  • Israel
      • Haifa, Israel
        • Lady Davis Carmel Medical Center, Department of Hematology,
      • Jerusalem, Israel
        • Hadassah Medical Center, Department of Hematology,
      • Kfar Saba, Israel
        • Meir Medical Center, Hematology Institute and Blood Bank
      • Petah Tikva, Israel
        • Rabin Medical Center, Clinic for Myeloproliferative Disorders
      • Tel Aviv, Israel
        • The Tel Aviv Sourasky Medical Center, Department of Internal Medicine
  • Italy
      • Bari, Italy
        • Cancer Institute "Giovanni Paolo II", IRCCS
      • Bologna, Italy
        • Polyclinic S. Orsola-Malpighi
      • Brescia, Italy
        • ASST Spedali Civili Brescia, Hematology Unit
      • Florence, Italy
        • Azienda Ospedaliero-Universitaria Careggi
      • Forlì, Italy
        • Scientific Institute of Romagna for the Study and Treatment of Cancer (IRST), IRCCS
      • Milan, Italy
        • Maggiore Polyclinic Hospital, Fondazione IRCCS Ca' Granda
      • Monza, Italy
        • ASST Monza - Ospedale San Gerardo
      • Naples, Italy
        • University Hospital "Federico II"
      • Novara, Italy
        • University Hospital "Maggiore della Carita" of Novara
      • Palermo, Italy
        • United Hospitals Villa Sofia Cervello
      • Pavia, Italy
        • Polyclinic San Matteo, IRCCS
      • Rimini, Italy
        • Hospital "Infermi" of Rimini
      • Rome, Italy
        • University Polyclinic Foundation "Agostino Gemelli"
      • Rome, Italy
        • Umberto I Polyclinic of Rome
      • Turin, Italy
        • City of Health and Science of Turin
      • Udine, Italy
        • Santa Maria della Misericordia University Hospital of Udine
      • Varese, Italy
        • ASST Sette Laghi Hospital
  • Japan
      • Chūō, Japan
        • University of Yamanashi Hospital
      • Fukuoka, Japan
        • Kyushu University Hospital
      • Fukushima, Japan
        • Fukushima Medical University Hospital
      • Miyagi, Japan
        • Tohoku University Hospital
      • Miyazaki, Japan
        • University of Miyazaki Hospital
      • Tokyo, Japan
        • Nippon Medical School Hospital
      • Tokyo, Japan
        • Juntendo University Hospital
      • Tokyo, Japan
        • Tokyo Medical University Hospital
      • Tsu, Japan
        • Mie University Hospital
      • Tōon, Japan
        • Ehime University Hospital
  • Kazakhstan
      • Aktobe, Kazakhstan
        • Aktobe Medical Center, Department of Hematology
      • Almaty, Kazakhstan
        • City Clinical Hospital #7, Hematology Department
      • Astana, Kazakhstan
        • Center for Hematology
      • Astana, Kazakhstan
        • National Research Oncology, Oncohematology Center
      • Karaganda, Kazakhstan
        • Hematology Center
      • Shymkent, Kazakhstan
        • City Oncological Center
      • Ust-Kamenogorsk, Kazakhstan
        • Center for Hematology
  • Poland
      • Bialystok, Poland
        • University Teaching Hospital in Bialystok
      • Gdansk, Poland
        • University Clinical Center in Gdansk
      • Katowice, Poland
        • Andrzej Mielecki Independent Public Clinical Hospital of Medical University of Silesia in Katowice, Department of Hematology and Bone Marrow Transplantation
      • Katowice, Poland
        • Pratia Oncology Katowice
      • Krakow, Poland
        • University Hospital in Krakow
      • Lodz, Poland
        • Nicolaus Copernicus Provincial Multispecialty Oncology and Traumatology Center in Lodz
      • Lublin, Poland
        • Independent Public Teaching Hospital No.1 in Lublin, Department of Hematooncology, Bone Marrow Transplantation and Chemotherapy
      • Nowy Sącz, Poland
        • Jedrzej Sniadecki Specialist Hospital in Nowy Sacz, Department of Hematology
      • Rzeszów, Poland
        • Frederic Chopin Provincial Teaching Hospital No. 1 in Rzeszow, Department of Hematology,
      • Torun, Poland
        • Nasz Lekarz Medical Outpatient Clinics Slawomir Jeka
      • Warsaw, Poland
        • Institute of Hematology and Transfusion Medicine, Teaching Department of Hematology
      • Wroclaw, Poland
        • Jan Mikulicz Radecki University Hospital in Wroclaw, Department and Clinic of Hematology, Blood Neoplasms and Bone Marrow Transplantation
  • Romania
      • Brasov, Romania
        • Onco Card Srl
      • Bucharest, Romania
        • Coltea Clinical Hospital
      • Bucharest, Romania
        • Fundeni Clinical Institute
      • Cluj-Napoca, Romania
        • Prof. Dr. Ion Chiricuta" Institute of Oncology
  • Russia
      • Moscow, Russia
        • City Clinical Hospital #40
      • Moscow, Russia
        • City Clinical Hospital n.a. V.V. Veresaev of the Moscow City Health
      • Moscow, Russia
        • S.P. Botkin City Clinical Hospital
      • Pyatigorsk, Russia
        • Clinic UZI 4D, LLC
      • Saint Petersburg, Russia
        • Research Institute of Hematology and Transfusiology
      • Saint Petersburg, Russia
        • S.M. Kirov Military Medical Academy, Department and Clinic for Intermediate-Level Training in Internal Medicine, Hematology Division
      • Saint Petersburg, Russia
        • V.A. Almazov North-West Federal Medical Research Center, Institute of Oncology and Hematology, Scientific Department of Clinical Oncology
      • Ufa, Russia
        • Bashkiria State Medical University, Department of Internal Medicine
      • Volgograd, Russia
        • Volgograd Regional Clinical Oncology Center
  • Serbia
      • Belgrade, Serbia
        • Clinical Center of Serbia, Clinic of Hematology
      • Novi Sad, Serbia
        • Clinical Center of Vojvodina, Clinic of Hematology
  • South Korea
      • Busan, South Korea
        • Pusan National University Hospital
      • Daegu, South Korea
        • Kyungpook National University Hospital
      • Seoul, South Korea
        • Samsung Medical Center
      • Seoul, South Korea
        • Seoul National University Hospital
      • Seoul, South Korea
        • The Catholic University of Korea, St. Mary's Hospital
    • South Korea
      • Seoul, South Korea, South Korea, 3722
        • Severance Hospital
  • Spain
      • Barcelona, Spain
        • Hospital Clinic De Barcelona
      • Barcelona, Spain
        • Hospital del Mar
      • Barcelona, Spain
        • University Hospital Vall d'Hebron
      • Madrid, Spain
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain
        • University Hospital 12 de Octubre, Department of Hematology
      • Murcia, Spain
        • Morales Meseguer University General Hospital, Department of Hematology and Hemotherapy
      • Salamanca, Spain
        • University Clinical Hospital of Salamanca, Department of Hematology
      • Seville, Spain
        • University Hospital Virgen del Rocio (HUVR)
      • Valencia, Spain
        • University Clinical Hospital of Valencia, Department of Hematology and Medical Oncology
  • Ukraine
      • Cherkasy, Ukraine
        • Cherkasy Regional Oncology Dispensary of Cherkasy Oblast Council, Regional Treatment and Diagnostic Hematology Center, Department of Hematology
      • Dnipro, Ukraine
        • City Clinical Hospital #4" under Dnipro City Council
      • Kharkiv, Ukraine
        • Communal Non-profit enterprise "Regional Center of Oncology", Department of Hematology
      • Kyiv, Ukraine
        • Kyiv City Clinical Hospital #9, Hematology Department #1
      • Kyiv, Ukraine
        • Kyiv Regional Oncology Center, Department of Hematology,
      • Kyiv, Ukraine
        • Limited Liability Company "City Doctor"
      • Lviv, Ukraine
        • Institute of Blood Pathology and Transfusion Medicine, Department of Hematology
      • Poltava, Ukraine
        • Poltava M.V. Sklifosovskyi Regional Clinical Hospital under Poltava Regional Council, Department of Hematology
  • United Kingdom
      • Gloucester, United Kingdom
        • Gloucestershire Royal Hospital
      • London, United Kingdom
        • Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
      • London, United Kingdom
        • Imperial College Healthcare NHS Trust - Hammersmith Hospital
      • Oxford, United Kingdom
        • Oxford University Hospitals NHS Trust - Churchill Hospital
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom
        • Royal Hallamshire Hospital, Department of Hematology
    • United Kingdom
      • Glasgow, United Kingdom, United Kingdom, G12 0ZD
        • Beatson West of Scotland Cancer Centre
      • London, United Kingdom, United Kingdom, E1 2ES
        • Barts Health NHS Trust - The Royal London Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham, (UAB) Hospital, Comprehensive Cancer Center
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Hospital
    • California
      • Duarte, California, United States, 91010
        • City of Hope
      • Los Angeles, California, United States, 90033
        • USC Norris Comprehensive Cancer Center
      • Los Angeles, California, United States, 90095
        • UCLA David Geffen School of Medicine
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Cancer Center
      • Boulder, Colorado, United States, 80303
        • Rocky Mountain Cancer Centers (US Oncology/McKesson)
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale School of Medicine
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Georgetown University Hospital
      • Washington D.C., District of Columbia, United States, 20037
        • George Washington University-Medical Faculty Associates
    • Florida
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
      • Chicago, Illinois, United States, 60637
        • The University of Chicago Medical Center
    • Kansas
      • Westwood, Kansas, United States, 66205
        • University of Kansas Cancer Center and Medical Pavilion
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
      • Baltimore, Maryland, United States, 21229
        • Saint Agnes Hospital
      • Bethesda, Maryland, United States, 20817
        • American Oncology Partners of Maryland, PA
      • Bethesda, Maryland, United States, 20817
        • Regional Cancer Care Associates LLC - CCBD Division
      • Columbia, Maryland, United States, 21044
        • Maryland Oncology Hematology, PA- Columbia
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Michigan Medicine Hematology Clinic-Rogel Cancer Center
      • Grand Rapids, Michigan, United States, 49546
        • Cancer and Hematology Centers of Western Michigan
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University School OF Medicine-Siteman Cancer Center
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Centers of Nevada- Twain Office
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • New York
      • New York, New York, United States, 10029
        • ICAHN School of Medicine at Mount Sinai
      • New York, New York, United States, 10021
        • Weill Cornell Medical College
      • New York, New York, United States, 10017
        • Columbia University Medical Center
      • New York, New York, United States, 10065
        • Memorial Sloan -Kettering Cancer Center
      • Rochester, New York, United States, 14642
        • University of Rochester
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Hospital
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Cleveland Clinic
      • Columbus, Ohio, United States, 43210
        • The James Cancer Hospital and Solove Research Institute
    • Oregon
      • Portland, Oregon, United States, 97239-3098
        • Oregon Health and Science University
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC Hillman Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • The Sarah Cannon Research Institute-Tennessee Oncology
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas MD Anderson Cancer Center
      • San Antonio, Texas, United States, 78229
        • Mays Cancer Center
      • San Antonio, Texas, United States, 78240
        • Texas Oncology- San Antonio
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah - Huntsman Cancer Institute
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Diagnosis and Inclusion Criteria

  1. Primary MF, post-polycythemia vera MF, or post-essential thrombocythemia MF (as defined by Tefferi and Vardiman 2008)
  2. Platelet count of <50,000/μL at Screening (Day -35 to Day -3)
  3. Dynamic International Prognostic Scoring System Intermediate-1, Intermediate-2, or High-Risk (Passamonti et al 2010)
  4. Palpable splenomegaly ≥5 cm below the lower costal margin in the midclavicular line as assessed by physical examination
  5. TSS of ≥10 on the MPN-SAF TSS 2.0 or a single symptom score of ≥5 or two symptoms of ≥3, including only the symptoms of left upper quadrant pain, bone pain, itching, or night sweats. The TSS criteria need only to be met on a single day.
  6. Age ≥18 years
  7. Eastern Cooperative Oncology Group performance status 0 to 2
  8. Peripheral blast count of <10% throughout the Screening period prior to randomization
  9. Absolute neutrophil count of ≥500/µL
  10. Left ventricular cardiac ejection fraction of ≥50% by echocardiogram or multigated acquisition scan
  11. Adequate liver and renal function, defined by liver transaminases (aspartate aminotransferase [AST]/serum glutamic-oxaloacetic transaminase [SGOT] and alanine aminotransferase [ALT]/serum glutamic pyruvic transaminase [SGPT]) ≤3 × the upper limit of normal (ULN) (AST/ALT ≤5 × ULN if transaminase elevation is related to MF), total bilirubin ≤4 x ULN (in cases where total bilirubin is elevated, direct bilirubin ≤4 × ULN, is required) and creatinine ≤2.5 mg/dL
  12. Adequate coagulation defined by prothrombin time/international normalized ratio and partial thromboplastin time ≤1.5 × ULN
  13. If fertile, willing to use highly effective birth control methods during the study (see Section 7.1.2.6 for acceptable birth control methods)
  14. Willing to undergo and able to tolerate frequent MRI or CT scan assessments during the study
  15. Able to understand and willing to complete symptom assessments using a patient-reported outcome instrument
  16. Provision of signed informed consent

Exclusion Criteria

  1. Life expectancy <6 months
  2. Completed allogeneic stem cell transplant or are eligible for and willing to complete other approved available therapy including allogeneic stem cell transplant
  3. History of splenectomy or planning to undergo splenectomy
  4. Splenic irradiation within the last 6 months
  5. Previously treated with pacritinib
  6. Treatment with any MF-directed therapy within 14 days prior to treatment Day 1
  7. Prior treatment with more than one JAK2 inhibitor

  8. 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).

  9. 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.
  10. Treatment with an experimental therapy, including MF-directed experimental therapies within 28 days prior to treatment Day 1
  11. 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
  12. 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)
  13. 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.
  14. 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
  15. 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.
  16. 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.
  17. 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).
  18. New York Heart Association Class II, III, or IV congestive heart failure
  19. Any active gastrointestinal or metabolic condition that could interfere with absorption of oral medication
  20. Active or uncontrolled inflammatory or chronic functional bowel disorder such as Crohn's Disease, inflammatory bowel disease, chronic diarrhea, or chronic constipation
  21. 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.
  22. 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
  23. Known seropositivity for human immunodeficiency (HIV) virus. For patients in Czech Republic, France and Italy only: testing for HIV is required during Screening.
  24. 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.
  25. Women who are pregnant or lactating
  26. Concurrent enrollment in another interventional trial
  27. Severe thrombocytopenia due to vitamin B12 deficiency, folate deficiency, or viral infection in the opinion of the investigator
  28. 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
  29. Persons deprived of their liberty by a judicial or administrative decision
  30. Persons subject to legal protection measures or unable to express their consent
  31. Temporarily incapacitated persons

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pacritinib 200 mg BID
To receive pacritinib 200 mg twice daily (BID) orally, at the same time of day, with or without food
Drug: Pacritinib
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
Active Comparator: Physician's Choice (P/C) therapy
The 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.
Drug: Physician's Choice medications
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.
Other Names:
  • corticosteroids
  • hydroxyurea
  • danazol
  • low-dose ruxolitinib

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Spleen volume
Time Frame: From baseline at 24 weeks
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
From baseline at 24 weeks
Total Symptom Score (TSS) (excluding tiredness)
Time Frame: From baseline at Week 24
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)
From baseline at Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: until 2.5 years after the date of randomization
To compare the overall survival (OS) of patients treated with pacritinib versus those treated with P/C
until 2.5 years after the date of randomization
Patient Global Impression of Change (PGIC) assessed at Week 24
Time Frame: End of Week 12 to 2 years following Week 24 visit
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
End of Week 12 to 2 years following Week 24 visit
To compare the safety of pacritinib versus P/C therapy
Time Frame: Randomization through 30 after last treatment
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.
Randomization through 30 after last treatment

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
SVR of ≥35%
Time Frame: Up to 24 Weeks
Time to achievement of SVR of ≥35%
Up to 24 Weeks
Best response in SVR
Time Frame: At 24 Weeks
Best response in SVR by MRI or CT scan
At 24 Weeks
>25% SVR
Time Frame: From baseline and at Week 24
Proportion of patients achieving >25% SVR
From baseline and at Week 24
Red blood cell (RBC)
Time Frame: Baseline to End of Treatment
Achievement of red blood cell (RBC) transfusion independence at Weeks 12 and 24
Baseline to End of Treatment
hemoglobin level
Time Frame: Weeks 12 and 24
Improvement in hemoglobin level without transfusion at Weeks 12 and 24
Weeks 12 and 24
platelet count
Time Frame: Weeks 12 and 24
Improvement in platelet count at Weeks 12 and 24
Weeks 12 and 24
platelet transfusions
Time Frame: Weeks 12 and 24
Frequency of platelet transfusions at Weeks 12 and 24
Weeks 12 and 24
PROMIS
Time Frame: Baseline to Week 24
Improvement in fatigue as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) v.1.0 - Fatigue from Baseline through Week 24
Baseline to Week 24
Leukemia-free survival (LFS)
Time Frame: Baseline to Week 24
Leukemia-free survival (LFS) of patients treated with pacritinib versus P/C therapy
Baseline to Week 24
The percentage of red blood cell transfusion-independent patients achieving a 1 g/dL and a 2 g/dL increase in hemoglobin
Time Frame: Baseline to 24 weeks
The percentage of red blood cell transfusion-independent patients at baseline achieving a 1 g/dL and a 2 g/dL increase in hemoglobin at week 24
Baseline to 24 weeks
The percentage of platelet transfusion-independent patients with improvement in grade of thrombocytopenia
Time Frame: Baseline to 24 weeks
The percentage of platelet transfusion-independent patients at baseline with improvement in grade of thrombocytopenia at week 24
Baseline to 24 weeks
The percentage of transfusion-dependent patients achieving transfusion independence and achieving 50% reduction in transfusion rate
Time Frame: Baseline to 24 weeks
The percentage of transfusion-dependent patients at baseline achieving transfusion independence and achieving 50% reduction in transfusion rate at week 24
Baseline to 24 weeks
mutated allelic burden, gene expression, and pharmacodynamic (PD) biomarkers
Time Frame: Baseline to up to 24 Weeks
Changes in mutated allelic burden, gene expression, and pharmacodynamic (PD) biomarkers
Baseline to up to 24 Weeks
The proportion of patients who experience a major adverse cardiac event (MACE)
Time Frame: Baseline to up to 24 Weeks

MACE is a composite endpoint that is considered to occur if any of the following TEAEs occur:

  • cardiovascular death, defined as death due to acute myocardial infarction, sudden cardiac death, death due to heart failure, death due to stroke, death due to cardiovascular procedures, death due to cardiovascular hemorrhage, or death due to peripheral artery disease
  • non-fatal myocardial infarction
  • non-fatal stroke of any classification, including reversible focal neurological defects with imaging evidence of a new cerebral lesion consistent with ischemia or hemorrhage
Baseline to up to 24 Weeks
Hemoglobin A1c
Time Frame: Baseline to Week 24
Changes in hemoglobin A1c
Baseline to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Swedish Orphan Biovitrum

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
PSI CRO

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Simran Singh, Sobi, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 26, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 5, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 13, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 24, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PAC203/PAC303
  • PAC303 (Other Identifier: Sobi, Inc.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Myelofibrosis

Clinical Trials on Pacritinib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings