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A Phase 3 Study of Pacritinib in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis
Sponsor: Swedish Orphan Biovitrum
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). 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
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
399
Start Date
2017-06-26
Completion Date
2027-07-30
Last Updated
2026-02-25
Healthy Volunteers
No
Conditions
Interventions
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
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.
Locations (207)
University of Alabama at Birmingham, (UAB) Hospital, Comprehensive Cancer Center
Birmingham, Alabama, United States
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
Hackensack University Medical Center
Hackensack, New Jersey, United States
Columbia University Medical Center
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Memorial Sloan -Kettering Cancer Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
Duke University Hospital
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
The Sarah Cannon Research Institute-Tennessee Oncology
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Mays Cancer Center
San Antonio, Texas, United States
Texas Oncology- San Antonio
San Antonio, Texas, United States
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Westmead Hospital
Sydney, New South Wales, Australia
Alfred Hospital, Malignant Hematology and Stem Cell Transplantation Service
Melbourne, Victoria, Australia
The Perth Blood Institute
Perth, Western Australia, Australia
Grodno University Hospital
Grodno, Belarus
Republican Research Center for Radiation Medicine and Human Ecology
Homyel, Belarus
Minsk Scientific and Practical Center of Surgery, Transplantology and Hematology
Minsk, Belarus
University Clinical Centre of the Republic of Srpska
Banja Luka, Bosnia and Herzegovina
University Clinical Center of Sarajevo
Sarajevo, Bosnia and Herzegovina
Integrare Therapeutics
Fortaleza, Ceará, Brazil
Hospital Sao Rafael
Salvador, Estado de Bahia, Brazil
Clinics Hospital, Federal University of Goias - (UFG)
Goiânia, Goiás, Brazil
Cetus Oncology Inc.
Belo Horizonte, Minas Gerais, Brazil
Clinical Hospital of the Federal University of Parana (HC - UFPR)
Curitiba, Paraná, Brazil
Saint Lucas Hospital of Copacabana
Rio de Janeiro, Rio de Janeiro, Brazil
Humane Clinic / Atena Research Institute
Mossoró, Rio Grande do Norte, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
Integrated Oncology Center of Rio Grande do Sul - Mother of God Hospital
Porto Alegre, Rio Grande do Sul, Brazil
Santa Catarina Health Research and Education Center (CEPEN)
Florianópolis, Santa Catarina, Brazil
State University of Campinas (UNICAMP) - Hemocenter
Campinas, São Paulo, Brazil
Hospital Amaral Carvalho
Jaú, São Paulo, Brazil
Jewish Hospital Albert Einstein
São Paulo, São Paulo, Brazil
Samaritano Hospital
São Paulo, São Paulo, Brazil
Sao Paulo University Clinical Hospital
São Paulo, São Paulo, Brazil
University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski"
Pleven, Bulgaria
University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv
Plovdiv, Bulgaria
Multiprofile Hospital for Active Treatment - Sofia, part of Military Medical Academy
Sofia, Bulgaria
Specialized Hospital for Active Treatment of Hematological Diseases
Sofia, Bulgaria
Multiprofile Hospital for Active Treatment "Sveta Marina"
Varna, Bulgaria
Tom Baker Cancer Center, Internal Medicine/Hematology
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
Providence Hematology - Vancouver
Vancouver, British Columbia, Canada
Eastern Regional Health Authority
St. John's, Newfoundland and Labrador, Canada
Nova Scotia Health Authority, Centre for Clinical Research
Halifax, Nova Scotia, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Jewish General Hospital; Clinical Research Unit
Montreal, Quebec, Canada
University Hospital Brno
Brno, Czechia
University Hospital Olomouc
Olomouc, Czechia
University Hospital Plzen
Pilsen, Czechia
University Hospital Kralovske Vinohrady, Clinic of Internal Hematology
Prague, Czechia
CHU Hôpital Amiens Sud
Amiens, France, France
CHU de Nimes - Hopital Universitaire Caremeau
Nîmes, France, France
La Conception Hospital
Marseille, France
Hôpital Saint-Louis
Paris, France
CHU Hopitaux de Bordeaux - Hôpital Haut-Lévêque
Pessac, France
Centre Hospitalier Lyon-Sud
Pierre-Bénite, France
University Hospital Center of Poitiers
Poitiers, France
JSC K. Eristavi National Center For Experimental and Clinical Surgery
Tbilisi, Georgia
LTD M.Zodelava's Hematology Center, Department of Hematology
Tbilisi, Georgia
LTD S.Khechinashvili University Hospital
Tbilisi, Georgia
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LTD
Tbilisi, Georgia
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC
Tbilisi, Georgia
Semmelweis University SE ÁOK I. sz. Belgyógyászati Klinika
Budapest, Hungary
University of Debrecen Clinical Center (Debreceni Egyetem Klinikai Központ)
Debrecen, Hungary
Somogy Megyei Kaposi Mór Oktató Kórház
Kaposvár, Hungary
Szabolcs-Szatmar-Bereg County Hospitals and University Teaching Hospital, Department of Hematology
Nyíregyháza, Hungary
Fejer County St. Gyorgy University Teaching Hospital, Department of Internal Medicine I
Székesfehérvár, Hungary
Gauhati Medical College and Hospital
Guwahati, Assam, India
Postgraduate Institute of Medical Education and Research (PGIMER)
Chandigarh, Chandigarh, India
Nirmal Hospital Pvt Ltd
Surat, Gujarat, India
Fortis Memorial Research Institute(FMRI)
Gurgaon, Haryana, India
Sahyadri Super Speciality Hospital
Pune, Maharashtra, India
Shri Ram Cancer Centre, Mahatma Gandhi Medical College & Hospital
Jaipur, Rajasthan, India
Meenakshi Mission Hospital And Research Centre (MMHRC)
Madurai, Tamil Nadu, India
Yashoda Hospitals
Hyderabad, Telangana, India
All India Institute of Medical Sciences
Dehradun, Uttarakhand, India
Netaji Subhash Chandra Bose Cancer Research Institute
Kolkata, West Bengal, India
Tata Medical Center
Kolkata, West Bengal, India
St. John's Medical College Hospital
Bengaluru, India
Max Super Speciality Hospital Saket (A Unit of Max Healthcare Institute Limited)
Delhi, India
Lady Davis Carmel Medical Center, Department of Hematology,
Haifa, Israel
Hadassah Medical Center, Department of Hematology,
Jerusalem, Israel
Meir Medical Center, Hematology Institute and Blood Bank
Kfar Saba, Israel
Rabin Medical Center, Clinic for Myeloproliferative Disorders
Petah Tikva, Israel
The Tel Aviv Sourasky Medical Center, Department of Internal Medicine
Tel Aviv, Israel
Cancer Institute "Giovanni Paolo II", IRCCS
Bari, Italy
Polyclinic S. Orsola-Malpighi
Bologna, Italy
ASST Spedali Civili Brescia, Hematology Unit
Brescia, Italy
Azienda Ospedaliero-Universitaria Careggi
Florence, Italy
Scientific Institute of Romagna for the Study and Treatment of Cancer (IRST), IRCCS
Forlì, Italy
Maggiore Polyclinic Hospital, Fondazione IRCCS Ca' Granda
Milan, Italy
ASST Monza - Ospedale San Gerardo
Monza, Italy
University Hospital "Federico II"
Naples, Italy
University Hospital "Maggiore della Carita" of Novara
Novara, Italy
United Hospitals Villa Sofia Cervello
Palermo, Italy
Polyclinic San Matteo, IRCCS
Pavia, Italy
Hospital "Infermi" of Rimini
Rimini, Italy
Umberto I Polyclinic of Rome
Rome, Italy
University Polyclinic Foundation "Agostino Gemelli"
Rome, Italy
City of Health and Science of Turin
Turin, Italy
Santa Maria della Misericordia University Hospital of Udine
Udine, Italy
ASST Sette Laghi Hospital
Varese, Italy
University of Yamanashi Hospital
Chūō, Japan
Kyushu University Hospital
Fukuoka, Japan
Fukushima Medical University Hospital
Fukushima, Japan
Tohoku University Hospital
Miyagi, Japan
University of Miyazaki Hospital
Miyazaki, Japan
Juntendo University Hospital
Tokyo, Japan
Nippon Medical School Hospital
Tokyo, Japan
Tokyo Medical University Hospital
Tokyo, Japan
Ehime University Hospital
Tōon, Japan
Mie University Hospital
Tsu, Japan
Aktobe Medical Center, Department of Hematology
Aktobe, Kazakhstan
City Clinical Hospital #7, Hematology Department
Almaty, Kazakhstan
Center for Hematology
Astana, Kazakhstan
National Research Oncology, Oncohematology Center
Astana, Kazakhstan
Hematology Center
Karaganda, Kazakhstan
City Oncological Center
Shymkent, Kazakhstan
Center for Hematology
Ust-Kamenogorsk, Kazakhstan
University Teaching Hospital in Bialystok
Bialystok, Poland
University Clinical Center in Gdansk
Gdansk, 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
Katowice, Poland
University Hospital in Krakow
Krakow, Poland
Nicolaus Copernicus Provincial Multispecialty Oncology and Traumatology Center in Lodz
Lodz, Poland
Independent Public Teaching Hospital No.1 in Lublin, Department of Hematooncology, Bone Marrow Transplantation and Chemotherapy
Lublin, Poland
Jedrzej Sniadecki Specialist Hospital in Nowy Sacz, Department of Hematology
Nowy Sącz, Poland
Frederic Chopin Provincial Teaching Hospital No. 1 in Rzeszow, Department of Hematology,
Rzeszów, Poland
Nasz Lekarz Medical Outpatient Clinics Slawomir Jeka
Torun, Poland
Institute of Hematology and Transfusion Medicine, Teaching Department of Hematology
Warsaw, Poland
Jan Mikulicz Radecki University Hospital in Wroclaw, Department and Clinic of Hematology, Blood Neoplasms and Bone Marrow Transplantation
Wroclaw, Poland
Onco Card Srl
Brasov, Romania
Coltea Clinical Hospital
Bucharest, Romania
Fundeni Clinical Institute
Bucharest, Romania
Prof. Dr. Ion Chiricuta" Institute of Oncology
Cluj-Napoca, Romania
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
Moscow, Russia
Clinic UZI 4D, LLC
Pyatigorsk, 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
Saint Petersburg, Russia
Bashkiria State Medical University, Department of Internal Medicine
Ufa, Russia
Volgograd Regional Clinical Oncology Center
Volgograd, Russia
Clinical Center of Serbia, Clinic of Hematology
Belgrade, Serbia
Clinical Center of Vojvodina, Clinic of Hematology
Novi Sad, Serbia
Severance Hospital
Seoul, South Korea, South Korea
Pusan National University Hospital
Busan, South Korea
Kyungpook National University Hospital
Daegu, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
The Catholic University of Korea, St. Mary's Hospital
Seoul, South Korea
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
University Hospital Vall d'Hebron
Barcelona, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
University Hospital 12 de Octubre, Department of Hematology
Madrid, Spain
Morales Meseguer University General Hospital, Department of Hematology and Hemotherapy
Murcia, Spain
University Clinical Hospital of Salamanca, Department of Hematology
Salamanca, Spain
University Hospital Virgen del Rocio (HUVR)
Seville, Spain
University Clinical Hospital of Valencia, Department of Hematology and Medical Oncology
Valencia, Spain
Cherkasy Regional Oncology Dispensary of Cherkasy Oblast Council, Regional Treatment and Diagnostic Hematology Center, Department of Hematology
Cherkasy, Ukraine
City Clinical Hospital #4" under Dnipro City Council
Dnipro, Ukraine
Communal Non-profit enterprise "Regional Center of Oncology", Department of Hematology
Kharkiv, 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"
Kyiv, Ukraine
Institute of Blood Pathology and Transfusion Medicine, Department of Hematology
Lviv, Ukraine
Poltava M.V. Sklifosovskyi Regional Clinical Hospital under Poltava Regional Council, Department of Hematology
Poltava, Ukraine
Royal Hallamshire Hospital, Department of Hematology
Sheffield, South Yorkshire, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, United Kingdom
Barts Health NHS Trust - The Royal London Hospital
London, United Kingdom, United Kingdom
Gloucestershire Royal Hospital
Gloucester, United Kingdom
Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
London, United Kingdom
Imperial College Healthcare NHS Trust - Hammersmith Hospital
London, United Kingdom
Oxford University Hospitals NHS Trust - Churchill Hospital
Oxford, United Kingdom