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

PHASE3RecruitingINTERVENTIONAL
Enrollment

399

Participants

Timeline

Start Date

June 26, 2017

Primary Completion Date

December 31, 2026

Study Completion Date

July 30, 2027

Conditions
Primary MyelofibrosisPost-polycythemia Vera MyelofibrosisPost-essential Thrombocythemia Myelofibrosis
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.

Trial Locations (207)

3722

RECRUITING

Severance Hospital, Seoul

10017

COMPLETED

Columbia University Medical Center, New York

10021

COMPLETED

Weill Cornell Medical College, New York

10029

COMPLETED

Icahn School of Medicine at Mount Sinai, New York

10065

COMPLETED

Memorial Sloan -Kettering Cancer Center, New York

14642

COMPLETED

University of Rochester, Rochester

15232

COMPLETED

UPMC Hillman Cancer Center, Pittsburgh

20007

COMPLETED

Georgetown University Hospital, Washington D.C.

20037

COMPLETED

George Washington University-Medical Faculty Associates, Washington D.C.

20817

COMPLETED

American Oncology Partners of Maryland, PA, Bethesda

COMPLETED

Regional Cancer Care Associates LLC - CCBD Division, Bethesda

21044

COMPLETED

Maryland Oncology Hematology, PA- Columbia, Columbia

21229

COMPLETED

Saint Agnes Hospital, Baltimore

21287

COMPLETED

Johns Hopkins University, Baltimore

27710

COMPLETED

Duke University Hospital, Durham

30900

RECRUITING

CHU de Nimes - Hopital Universitaire Caremeau, Nîmes

33331

COMPLETED

Cleveland Clinic Florida, Weston

33604

RECRUITING

CHU Hopitaux de Bordeaux - Hôpital Haut-Lévêque, Pessac

35294

COMPLETED

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

37203

COMPLETED

The Sarah Cannon Research Institute-Tennessee Oncology, Nashville

43210

COMPLETED

The James Cancer Hospital and Solove Research Institute, Columbus

44106

COMPLETED

Cleveland Clinic, Cleveland

48109

COMPLETED

Michigan Medicine Hematology Clinic-Rogel Cancer Center, Ann Arbor

49546

COMPLETED

Cancer and Hematology Centers of Western Michigan, Grand Rapids

60611

COMPLETED

Northwestern Memorial Hospital, Chicago

60612

COMPLETED

Rush University Medical Center, Chicago

60637

COMPLETED

The University of Chicago Medical Center, Chicago

63110

COMPLETED

Washington University School of Medicine-Siteman Cancer Center, St Louis

66205

COMPLETED

University of Kansas Cancer Center and Medical Pavilion, Westwood

70121

COMPLETED

Ochsner Medical Center, New Orleans

77030

COMPLETED

The University of Texas MD Anderson Cancer Center, Houston

78229

COMPLETED

Mays Cancer Center, San Antonio

78240

COMPLETED

Texas Oncology- San Antonio, San Antonio

80045

COMPLETED

University of Colorado Cancer Center, Aurora

80054

SUSPENDED

CHU Hôpital Amiens Sud, Amiens

80303

COMPLETED

Rocky Mountain Cancer Centers (US Oncology/McKesson), Boulder

84112

COMPLETED

University of Utah - Huntsman Cancer Institute, Salt Lake City

85054

COMPLETED

Mayo Clinic Hospital, Phoenix

89169

COMPLETED

Comprehensive Cancer Centers of Nevada- Twain Office, Las Vegas

90033

COMPLETED

USC Norris Comprehensive Cancer Center, Los Angeles

90095

COMPLETED

UCLA David Geffen School of Medicine, Los Angeles

91010

COMPLETED

City of Hope, Duarte

98109

COMPLETED

Fred Hutchinson Cancer Research Center, Seattle

06510

COMPLETED

Yale School of Medicine, New Haven

07601

COMPLETED

Hackensack University Medical Center, Hackensack

97239-3098

COMPLETED

Oregon Health and Science University, Portland

Unknown

RECRUITING

Westmead Hospital, Sydney

RECRUITING

Alfred Hospital, Malignant Hematology and Stem Cell Transplantation Service, Melbourne

RECRUITING

The Perth Blood Institute, Perth

COMPLETED

Grodno University Hospital, Grodno

RECRUITING

Republican Research Center for Radiation Medicine and Human Ecology, Homyel

RECRUITING

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

RECRUITING

University Clinical Centre of the Republic of Srpska, Banja Luka

RECRUITING

University Clinical Center of Sarajevo, Sarajevo

RECRUITING

Integrare Therapeutics, Fortaleza

RECRUITING

Hospital Sao Rafael, Salvador

RECRUITING

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

RECRUITING

Cetus Oncology Inc., Belo Horizonte

RECRUITING

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

RECRUITING

Humane Clinic / Atena Research Institute, Mossoró

RECRUITING

Hospital Moinhos de Vento, Porto Alegre

RECRUITING

Integrated Oncology Center of Rio Grande do Sul - Mother of God Hospital, Porto Alegre

RECRUITING

Santa Catarina Health Research and Education Center (CEPEN), Florianópolis

RECRUITING

State University of Campinas (UNICAMP) - Hemocenter, Campinas

RECRUITING

Hospital Amaral Carvalho, Jaú

RECRUITING

Jewish Hospital Albert Einstein, São Paulo

RECRUITING

Samaritano Hospital, São Paulo

RECRUITING

Sao Paulo University Clinical Hospital, São Paulo

RECRUITING

Saint Lucas Hospital of Copacabana, Rio de Janeiro

RECRUITING

"University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski", Pleven

RECRUITING

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

RECRUITING

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

RECRUITING

Specialized Hospital for Active Treatment of Hematological Diseases, Sofia

SUSPENDED

"Multiprofile Hospital for Active Treatment Sveta Marina", Varna

SUSPENDED

Tom Baker Cancer Center, Internal Medicine/Hematology, Calgary

COMPLETED

University of Alberta, Edmonton

RECRUITING

Providence Hematology - Vancouver, Vancouver

SUSPENDED

Eastern Regional Health Authority, St. John's

RECRUITING

Nova Scotia Health Authority, Centre for Clinical Research, Halifax

RECRUITING

Princess Margaret Cancer Centre, Toronto

RECRUITING

Jewish General Hospital; Clinical Research Unit, Montreal

RECRUITING

University Hospital Brno, Brno

RECRUITING

University Hospital Olomouc, Olomouc

RECRUITING

University Hospital Plzen, Pilsen

RECRUITING

University Hospital Kralovske Vinohrady, Clinic of Internal Hematology, Prague

SUSPENDED

La Conception Hospital, Marseille

RECRUITING

Hôpital Saint-Louis, Paris

RECRUITING

Centre Hospitalier Lyon-Sud, Pierre-Bénite

RECRUITING

University Hospital Center of Poitiers, Poitiers

RECRUITING

JSC K. Eristavi National Center For Experimental and Clinical Surgery, Tbilisi

COMPLETED

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

COMPLETED

LTD S.Khechinashvili University Hospital, Tbilisi

COMPLETED

Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LTD, Tbilisi

RECRUITING

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

COMPLETED

Semmelweis University SE ÁOK I. sz. Belgyógyászati Klinika, Budapest

RECRUITING

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

RECRUITING

Somogy Megyei Kaposi Mór Oktató Kórház, Kaposvár

RECRUITING

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

RECRUITING

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

RECRUITING

Gauhati Medical College and Hospital, Guwahati

RECRUITING

Nirmal Hospital Pvt Ltd, Surat

RECRUITING

Fortis Memorial Research Institute(FMRI), Gurgaon

RECRUITING

Sahyadri Super Speciality Hospital, Pune

RECRUITING

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

RECRUITING

Meenakshi Mission Hospital And Research Centre (MMHRC), Madurai

RECRUITING

Yashoda Hospitals, Hyderabad

RECRUITING

All India Institute of Medical Sciences, Dehradun

RECRUITING

Netaji Subhash Chandra Bose Cancer Research Institute, Kolkata

RECRUITING

Tata Medical Center, Kolkata

RECRUITING

St. John's Medical College Hospital, Bengaluru

RECRUITING

Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh

RECRUITING

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

RECRUITING

Lady Davis Carmel Medical Center, Department of Hematology,, Haifa

RECRUITING

Hadassah Medical Center, Department of Hematology,, Jerusalem

RECRUITING

Meir Medical Center, Hematology Institute and Blood Bank, Kfar Saba

COMPLETED

Rabin Medical Center, Clinic for Myeloproliferative Disorders, Petah Tikva

COMPLETED

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

RECRUITING

"Cancer Institute Giovanni Paolo II, IRCCS", Bari

RECRUITING

Polyclinic S. Orsola-Malpighi, Bologna

RECRUITING

ASST Spedali Civili Brescia, Hematology Unit, Brescia

RECRUITING

Azienda Ospedaliero-Universitaria Careggi, Florence

RECRUITING

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

RECRUITING

Maggiore Polyclinic Hospital, Fondazione IRCCS Ca' Granda, Milan

RECRUITING

ASST Monza - Ospedale San Gerardo, Monza

RECRUITING

"University Hospital Federico II", Naples

RECRUITING

"University Hospital Maggiore della Carita of Novara", Novara

RECRUITING

United Hospitals Villa Sofia Cervello, Palermo

COMPLETED

Polyclinic San Matteo, IRCCS, Pavia

COMPLETED

"Hospital Infermi of Rimini", Rimini

RECRUITING

Umberto I Polyclinic of Rome, Rome

RECRUITING

"University Polyclinic Foundation Agostino Gemelli", Rome

RECRUITING

City of Health and Science of Turin, Turin

RECRUITING

Santa Maria della Misericordia University Hospital of Udine, Udine

RECRUITING

ASST Sette Laghi Hospital, Varese

RECRUITING

University of Yamanashi Hospital, Chūō

RECRUITING

Kyushu University Hospital, Fukuoka

RECRUITING

Fukushima Medical University Hospital, Fukushima

RECRUITING

Tohoku University Hospital, Miyagi

RECRUITING

University of Miyazaki Hospital, Miyazaki

RECRUITING

Juntendo University Hospital, Tokyo

RECRUITING

Nippon Medical School Hospital, Tokyo

RECRUITING

Tokyo Medical University Hospital, Tokyo

RECRUITING

Ehime University Hospital, Tōon

RECRUITING

Mie University Hospital, Tsu

RECRUITING

Aktobe Medical Center, Department of Hematology, Aktobe

RECRUITING

City Clinical Hospital #7, Hematology Department, Almaty

RECRUITING

Center for Hematology, Astana

RECRUITING

National Research Oncology, Oncohematology Center, Astana

RECRUITING

Hematology Center, Karaganda

RECRUITING

City Oncological Center, Shymkent

RECRUITING

Center for Hematology, Ust-Kamenogorsk

RECRUITING

University Teaching Hospital in Bialystok, Bialystok

RECRUITING

University Clinical Center in Gdansk, Gdansk

RECRUITING

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

RECRUITING

Pratia Oncology Katowice, Katowice

RECRUITING

University Hospital in Krakow, Krakow

RECRUITING

Nicolaus Copernicus Provincial Multispecialty Oncology and Traumatology Center in Lodz, Lodz

RECRUITING

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

RECRUITING

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

COMPLETED

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

SUSPENDED

Nasz Lekarz Medical Outpatient Clinics Slawomir Jeka, Torun

SUSPENDED

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

RECRUITING

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

RECRUITING

Onco Card Srl, Brasov

RECRUITING

Coltea Clinical Hospital, Bucharest

RECRUITING

Fundeni Clinical Institute, Bucharest

RECRUITING

"Prof. Dr. Ion Chiricuta Institute of Oncology", Cluj-Napoca

COMPLETED

City Clinical Hospital #40, Moscow

COMPLETED

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

COMPLETED

S.P. Botkin City Clinical Hospital, Moscow

COMPLETED

Clinic UZI 4D, LLC, Pyatigorsk

COMPLETED

Research Institute of Hematology and Transfusiology, Saint Petersburg

COMPLETED

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

COMPLETED

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

COMPLETED

Bashkiria State Medical University, Department of Internal Medicine, Ufa

COMPLETED

Volgograd Regional Clinical Oncology Center, Volgograd

RECRUITING

Clinical Center of Serbia, Clinic of Hematology, Belgrade

SUSPENDED

Clinical Center of Vojvodina, Clinic of Hematology, Novi Sad

RECRUITING

Pusan National University Hospital, Busan

RECRUITING

Kyungpook National University Hospital, Daegu

RECRUITING

Samsung Medical Center, Seoul

RECRUITING

Seoul National University Hospital, Seoul

RECRUITING

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

RECRUITING

Hospital Clínic de Barcelona, Barcelona

SUSPENDED

Hospital del Mar, Barcelona

RECRUITING

University Hospital Vall d'Hebron, Barcelona

RECRUITING

Hospital Universitario Ramón y Cajal, Madrid

RECRUITING

University Hospital 12 de Octubre, Department of Hematology, Madrid

SUSPENDED

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

RECRUITING

University Clinical Hospital of Salamanca, Department of Hematology, Salamanca

RECRUITING

University Hospital Virgen del Rocio (HUVR), Seville

SUSPENDED

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

COMPLETED

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

COMPLETED

"City Clinical Hospital #4 under Dnipro City Council", Dnipro

COMPLETED

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

COMPLETED

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

COMPLETED

Kyiv Regional Oncology Center, Department of Hematology,, Kyiv

COMPLETED

"Limited Liability Company City Doctor", Kyiv

COMPLETED

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

COMPLETED

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

COMPLETED

Royal Hallamshire Hospital, Department of Hematology, Sheffield

RECRUITING

Gloucestershire Royal Hospital, Gloucester

RECRUITING

Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital, London

RECRUITING

Imperial College Healthcare NHS Trust - Hammersmith Hospital, London

RECRUITING

Oxford University Hospitals NHS Trust - Churchill Hospital, Oxford

G12 0ZD

COMPLETED

Beatson West of Scotland Cancer Centre, Glasgow

E1 2ES

RECRUITING

Barts Health NHS Trust - The Royal London Hospital, London

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

PSI CRO

INDUSTRY

lead

Swedish Orphan Biovitrum

INDUSTRY