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RECRUITING
NCT03165734
PHASE3

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

Sponsor: Swedish Orphan Biovitrum

View on ClinicalTrials.gov

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

Interventions

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

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.

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