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)

Who is this study for? Adult patients with Primary Myelofibrosis
What treatments are being studied? Pacritinib
Status: Recruiting
Location: See all (203) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Primary MF, post-polycythemia vera MF, or post-essential thrombocythemia MF (as defined by Tefferi and Vardiman 2008

• Platelet count of \<50,000/μL at Screening (Day -35 to Day -3)

• Dynamic International Prognostic Scoring System Intermediate-1, Intermediate-2, or High-Risk (Passamonti et al 2010

• Palpable splenomegaly ≥5 cm below the lower costal margin (LCM) in the midclavicular line as assessed by physical examination

• 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.

• Age ≥18 years

• Eastern Cooperative Oncology Group performance status 0 to 2

• Peripheral blast count of \<10% throughout the Screening period prior to randomization

• Absolute neutrophil count of ≥500/µL

⁃ Left ventricular cardiac ejection fraction of ≥50% by echocardiogram or multigated acquisition scan

⁃ 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

⁃ Adequate coagulation defined by prothrombin time/international normalized ratio and partial thromboplastin time ≤1.5 × ULN

⁃ If fertile, willing to use highly effective birth control methods during the study

⁃ Willing to undergo and able to tolerate frequent MRI or CT scan assessments during the study

⁃ Able to understand and willing to complete symptom assessments using a patient-reported outcome instrument

⁃ Provision of signed informed consent

Locations
United States
Alabama
University of Alabama at Birmingham, (UAB) Hospital, Comprehensive Cancer Center
COMPLETED
Birmingham
Arizona
Mayo Clinic Hospital
COMPLETED
Phoenix
California
City of Hope
COMPLETED
Duarte
UCLA David Geffen School of Medicine
COMPLETED
Los Angeles
USC Norris Comprehensive Cancer Center
COMPLETED
Los Angeles
Colorado
University of Colorado Cancer Center
COMPLETED
Aurora
Rocky Mountain Cancer Centers (US Oncology/McKesson)
COMPLETED
Boulder
Connecticut
Yale School of Medicine
COMPLETED
New Haven
Washington, D.c.
George Washington University-Medical Faculty Associates
COMPLETED
Washington D.c.
Georgetown University Hospital
COMPLETED
Washington D.c.
Florida
Cleveland Clinic Florida
COMPLETED
Weston
Illinois
Northwestern Memorial Hospital
COMPLETED
Chicago
Rush University Medical Center
COMPLETED
Chicago
The University of Chicago Medical Center
COMPLETED
Chicago
Kansas
University of Kansas Cancer Center and Medical Pavilion
COMPLETED
Westwood
Louisiana
Ochsner Medical Center
COMPLETED
New Orleans
Maryland
Johns Hopkins University
COMPLETED
Baltimore
Saint Agnes Hospital
COMPLETED
Baltimore
American Oncology Partners of Maryland, PA
COMPLETED
Bethesda
Regional Cancer Care Associates LLC - CCBD Division
COMPLETED
Bethesda
Maryland Oncology Hematology, PA- Columbia
COMPLETED
Columbia
Michigan
Michigan Medicine Hematology Clinic-Rogel Cancer Center
COMPLETED
Ann Arbor
Cancer and Hematology Centers of Western Michigan
COMPLETED
Grand Rapids
Missouri
Washington University School of Medicine-Siteman Cancer Center
COMPLETED
St Louis
North Carolina
Duke University Hospital
COMPLETED
Durham
New Jersey
Hackensack University Medical Center
COMPLETED
Hackensack
Nevada
Comprehensive Cancer Centers of Nevada- Twain Office
COMPLETED
Las Vegas
New York
Columbia University Medical Center
COMPLETED
New York
Icahn School of Medicine at Mount Sinai
COMPLETED
New York
Memorial Sloan -Kettering Cancer Center
COMPLETED
New York
Weill Cornell Medical College
COMPLETED
New York
University of Rochester
COMPLETED
Rochester
Ohio
Cleveland Clinic
COMPLETED
Cleveland
The James Cancer Hospital and Solove Research Institute
COMPLETED
Columbus
Oregon
Oregon Health and Science University
COMPLETED
Portland
Pennsylvania
UPMC Hillman Cancer Center
COMPLETED
Pittsburgh
Tennessee
The Sarah Cannon Research Institute-Tennessee Oncology
COMPLETED
Nashville
Texas
The University of Texas MD Anderson Cancer Center
COMPLETED
Houston
Mays Cancer Center
COMPLETED
San Antonio
Texas Oncology- San Antonio
COMPLETED
San Antonio
Utah
University of Utah - Huntsman Cancer Institute
COMPLETED
Salt Lake City
Washington
Fred Hutchinson Cancer Research Center
COMPLETED
Seattle
Other Locations
Australia
Alfred Hospital, Malignant Hematology and Stem Cell Transplantation Service
RECRUITING
Melbourne
The Perth Blood Institute
RECRUITING
Perth
Westmead Hospital
RECRUITING
Sydney
Belarus
Grodno University Hospital
COMPLETED
Grodno
Republican Research Center for Radiation Medicine and Human Ecology
RECRUITING
Homyel
Minsk Scientific and Practical Center of Surgery, Transplantology and Hematology
RECRUITING
Minsk
Bosnia and Herzegovina
University Clinical Centre of the Republic of Srpska
RECRUITING
Banja Luka
University Clinical Center of Sarajevo
RECRUITING
Sarajevo
Brazil
Cetus Oncology Inc.
RECRUITING
Belo Horizonte
State University of Campinas (UNICAMP) - Hemocenter
RECRUITING
Campinas
Clinical Hospital of the Federal University of Parana (HC - UFPR)
RECRUITING
Curitiba
Santa Catarina Health Research and Education Center (CEPEN)
RECRUITING
Florianópolis
Integrare Therapeutics
RECRUITING
Fortaleza
Clinics Hospital, Federal University of Goias - (UFG)
RECRUITING
Goiânia
Hospital Amaral Carvalho
RECRUITING
Jaú
Humane Clinic / Atena Research Institute
RECRUITING
Mossoró
Hospital Moinhos de Vento
RECRUITING
Porto Alegre
Integrated Oncology Center of Rio Grande do Sul - Mother of God Hospital
RECRUITING
Porto Alegre
Saint Lucas Hospital of Copacabana
RECRUITING
Rio De Janeiro
Hospital Sao Rafael
RECRUITING
Salvador
Jewish Hospital Albert Einstein
RECRUITING
São Paulo
Samaritano Hospital
RECRUITING
São Paulo
Sao Paulo University Clinical Hospital
RECRUITING
São Paulo
Bulgaria
University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski
RECRUITING
Pleven
University Multiprofile Hospital for Active Treatment Sveti Georgi, Plovdiv
RECRUITING
Plovdiv
Multiprofile Hospital for Active Treatment - Sofia, part of Military Medical Academy
RECRUITING
Sofia
Specialized Hospital for Active Treatment of Hematological Diseases
RECRUITING
Sofia
Multiprofile Hospital for Active Treatment Sveta Marina
SUSPENDED
Varna
Canada
Tom Baker Cancer Center, Internal Medicine/Hematology
SUSPENDED
Calgary
University of Alberta
COMPLETED
Edmonton
Nova Scotia Health Authority, Centre for Clinical Research
RECRUITING
Halifax
Jewish General Hospital; Clinical Research Unit
RECRUITING
Montreal
Eastern Regional Health Authority
SUSPENDED
St. John's
Princess Margaret Cancer Centre
RECRUITING
Toronto
Providence Hematology - Vancouver
RECRUITING
Vancouver
France
CHU Hôpital Amiens Sud
SUSPENDED
Amiens
La Conception Hospital
SUSPENDED
Marseille
CHU de Nimes - Hopital Universitaire Caremeau
RECRUITING
Nîmes
Hôpital Saint-Louis
RECRUITING
Paris
CHU Hopitaux de Bordeaux - Hôpital Haut-Lévêque
RECRUITING
Pessac
Centre Hospitalier Lyon-Sud
RECRUITING
Pierre-bénite
University Hospital Center of Poitiers
RECRUITING
Poitiers
Georgia
JSC K. Eristavi National Center For Experimental and Clinical Surgery
RECRUITING
Tbilisi
LTD M.Zodelava's Hematology Center, Department of Hematology
COMPLETED
Tbilisi
LTD S.Khechinashvili University Hospital
COMPLETED
Tbilisi
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LTD
COMPLETED
Tbilisi
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC
RECRUITING
Tbilisi
Hungary
Semmelweis University SE ÁOK I. sz. Belgyógyászati Klinika
COMPLETED
Budapest
University of Debrecen Clinical Center (Debreceni Egyetem Klinikai Központ)
RECRUITING
Debrecen
Somogy Megyei Kaposi Mór Oktató Kórház
RECRUITING
Kaposvár
Szabolcs-Szatmar-Bereg County Hospitals and University Teaching Hospital, Department of Hematology
RECRUITING
Nyíregyháza
Fejer County St. Gyorgy University Teaching Hospital, Department of Internal Medicine I
RECRUITING
Székesfehérvár
India
St. John's Medical College Hospital
RECRUITING
Bengaluru
Postgraduate Institute of Medical Education and Research (PGIMER)
RECRUITING
Chandigarh
All India Institute of Medical Sciences
RECRUITING
Dehradun
Max Super Speciality Hospital Saket (A Unit of Max Healthcare Institute Limited)
RECRUITING
Delhi
Fortis Memorial Research Institute(FMRI)
RECRUITING
Gurgaon
Gauhati Medical College and Hospital
RECRUITING
Guwahati
Yashoda Hospitals
RECRUITING
Hyderabad
Shri Ram Cancer Centre, Mahatma Gandhi Medical College & Hospital
RECRUITING
Jaipur
Netaji Subhash Chandra Bose Cancer Research Institute
RECRUITING
Kolkata
Tata Medical Center
RECRUITING
Kolkata
Meenakshi Mission Hospital And Research Centre (MMHRC)
RECRUITING
Madurai
Sahyadri Super Speciality Hospital
RECRUITING
Pune
Nirmal Hospital Pvt Ltd
RECRUITING
Surat
Israel
Lady Davis Carmel Medical Center, Department of Hematology,
RECRUITING
Haifa
Hadassah Medical Center, Department of Hematology,
RECRUITING
Jerusalem
Meir Medical Center, Hematology Institute and Blood Bank
RECRUITING
Kfar Saba
Rabin Medical Center, Clinic for Myeloproliferative Disorders
COMPLETED
Petah Tikva
The Tel Aviv Sourasky Medical Center, Department of Internal Medicine
COMPLETED
Tel Aviv
Italy
Cancer Institute Giovanni Paolo II, IRCCS
RECRUITING
Bari
Polyclinic S. Orsola-Malpighi
RECRUITING
Bologna
ASST Spedali Civili Brescia, Hematology Unit
RECRUITING
Brescia
Azienda Ospedaliero-Universitaria Careggi
RECRUITING
Florence
Scientific Institute of Romagna for the Study and Treatment of Cancer (IRST), IRCCS
RECRUITING
Forlì
Maggiore Polyclinic Hospital, Fondazione IRCCS Ca' Granda
RECRUITING
Milan
ASST Monza - Ospedale San Gerardo
RECRUITING
Monza
University Hospital Federico II
RECRUITING
Naples
University Hospital Maggiore della Carita of Novara
RECRUITING
Novara
United Hospitals Villa Sofia Cervello
RECRUITING
Palermo
Polyclinic San Matteo, IRCCS
COMPLETED
Pavia
Hospital Infermi of Rimini
COMPLETED
Rimini
Umberto I Polyclinic of Rome
RECRUITING
Rome
University Polyclinic Foundation Agostino Gemelli
RECRUITING
Rome
City of Health and Science of Turin
RECRUITING
Turin
Santa Maria della Misericordia University Hospital of Udine
RECRUITING
Udine
ASST Sette Laghi Hospital
RECRUITING
Varese
Japan
University of Yamanashi Hospital
RECRUITING
Chūō
Kyushu University Hospital
RECRUITING
Fukuoka
Fukushima Medical University Hospital
RECRUITING
Fukushima
Tohoku University Hospital
RECRUITING
Miyagi
University of Miyazaki Hospital
RECRUITING
Miyazaki
Juntendo University Hospital
RECRUITING
Tokyo
Nippon Medical School Hospital
RECRUITING
Tokyo
Tokyo Medical University Hospital
RECRUITING
Tokyo
Ehime University Hospital
RECRUITING
Tōon
Mie University Hospital
RECRUITING
Tsu
Kazakhstan
Aktobe Medical Center, Department of Hematology
RECRUITING
Aktobe
City Clinical Hospital #7, Hematology Department
RECRUITING
Almaty
Center for Hematology
RECRUITING
Astana
National Research Oncology, Oncohematology Center
RECRUITING
Astana
Hematology Center
RECRUITING
Karaganda
City Oncological Center
RECRUITING
Shymkent
Center for Hematology
RECRUITING
Ust-kamenogorsk
Poland
University Teaching Hospital in Bialystok
RECRUITING
Bialystok
University Clinical Center in Gdansk
RECRUITING
Gdansk
Andrzej Mielecki Independent Public Clinical Hospital of Medical University of Silesia in Katowice, Department of Hematology and Bone Marrow Transplantation
RECRUITING
Katowice
Pratia Oncology Katowice
RECRUITING
Katowice
University Hospital in Krakow
RECRUITING
Krakow
Nicolaus Copernicus Provincial Multispecialty Oncology and Traumatology Center in Lodz
RECRUITING
Lodz
Independent Public Teaching Hospital No.1 in Lublin, Department of Hematooncology, Bone Marrow Transplantation and Chemotherapy
RECRUITING
Lublin
Jedrzej Sniadecki Specialist Hospital in Nowy Sacz, Department of Hematology
RECRUITING
Nowy Sącz
Frederic Chopin Provincial Teaching Hospital No. 1 in Rzeszow, Department of Hematology,
COMPLETED
Rzeszów
Nasz Lekarz Medical Outpatient Clinics Slawomir Jeka
SUSPENDED
Torun
Institute of Hematology and Transfusion Medicine, Teaching Department of Hematology
SUSPENDED
Warsaw
Jan Mikulicz Radecki University Hospital in Wroclaw, Department and Clinic of Hematology, Blood Neoplasms and Bone Marrow Transplantation
RECRUITING
Wroclaw
Republic of Korea
Pusan National University Hospital
RECRUITING
Busan
Kyungpook National University Hospital
RECRUITING
Daegu
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital
RECRUITING
Seoul
The Catholic University of Korea, St. Mary's Hospital
RECRUITING
Seoul
Romania
Onco Card Srl
RECRUITING
Brasov
Coltea Clinical Hospital
RECRUITING
Bucharest
Fundeni Clinical Institute
RECRUITING
Bucharest
Prof. Dr. Ion Chiricuta Institute of Oncology
RECRUITING
Cluj-napoca
Russian Federation
City Clinical Hospital #40
COMPLETED
Moscow
City Clinical Hospital n.a. V.V. Veresaev of the Moscow City Health
COMPLETED
Moscow
S.P. Botkin City Clinical Hospital
COMPLETED
Moscow
Clinic UZI 4D, LLC
COMPLETED
Pyatigorsk
Research Institute of Hematology and Transfusiology
COMPLETED
Saint Petersburg
S.M. Kirov Military Medical Academy, Department and Clinic for Intermediate-Level Training in Internal Medicine, Hematology Division
COMPLETED
Saint Petersburg
V.A. Almazov North-West Federal Medical Research Center, Institute of Oncology and Hematology, Scientific Department of Clinical Oncology
COMPLETED
Saint Petersburg
Bashkiria State Medical University, Department of Internal Medicine
COMPLETED
Ufa
Volgograd Regional Clinical Oncology Center
COMPLETED
Volgograd
Serbia
Clinical Center of Serbia, Clinic of Hematology
RECRUITING
Belgrade
Clinical Center of Vojvodina, Clinic of Hematology
SUSPENDED
Novi Sad
Spain
Hospital Clínic de Barcelona
RECRUITING
Barcelona
Hospital del Mar
SUSPENDED
Barcelona
University Hospital Vall d'Hebron
RECRUITING
Barcelona
Hospital Universitario Ramón y Cajal
RECRUITING
Madrid
University Hospital 12 de Octubre, Department of Hematology
RECRUITING
Madrid
Morales Meseguer University General Hospital, Department of Hematology and Hemotherapy
SUSPENDED
Murcia
University Clinical Hospital of Salamanca, Department of Hematology
RECRUITING
Salamanca
University Hospital Virgen del Rocio (HUVR)
RECRUITING
Seville
University Clinical Hospital of Valencia, Department of Hematology and Medical Oncology
SUSPENDED
Valencia
Ukraine
Cherkasy Regional Oncology Dispensary of Cherkasy Oblast Council, Regional Treatment and Diagnostic Hematology Center, Department of Hematology
COMPLETED
Cherkasy
City Clinical Hospital #4 under Dnipro City Council
COMPLETED
Dnipro
Communal Non-profit enterprise Regional Center of Oncology, Department of Hematology
COMPLETED
Kharkiv
Kyiv City Clinical Hospital #9, Hematology Department #1
COMPLETED
Kyiv
Kyiv Regional Oncology Center, Department of Hematology,
COMPLETED
Kyiv
Limited Liability Company City Doctor
COMPLETED
Kyiv
Institute of Blood Pathology and Transfusion Medicine, Department of Hematology
COMPLETED
Lviv
Poltava M.V. Sklifosovskyi Regional Clinical Hospital under Poltava Regional Council, Department of Hematology
COMPLETED
Poltava
United Kingdom
Beatson West of Scotland Cancer Centre
COMPLETED
Glasgow
Gloucestershire Royal Hospital
RECRUITING
Gloucester
Barts Health NHS Trust - The Royal London Hospital
RECRUITING
London
Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
RECRUITING
London
Imperial College Healthcare NHS Trust - Hammersmith Hospital
RECRUITING
London
Oxford University Hospitals NHS Trust - Churchill Hospital
RECRUITING
Oxford
Royal Hallamshire Hospital, Department of Hematology
COMPLETED
Sheffield
Contact Information
Primary
Study Contact
medical.info@sobi.com
+4686972000
Time Frame
Start Date: 2017-06-26
Estimated Completion Date: 2027-07-30
Participants
Target number of participants: 399
Treatments
Experimental: Pacritinib 200 mg BID
To receive pacritinib 200 mg twice daily (BID) orally, at the same time of day, with or without food
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.
Sponsors
Collaborators: PSI CRO
Leads: Swedish Orphan Biovitrum

This content was sourced from clinicaltrials.gov