A Phase 3 Study of Pacritinib in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis
PACIFICA
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)
2 other identifiers
interventional
407
24 countries
207
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2017
Longer than P75 for phase_3
207 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2017
CompletedFirst Posted
Study publicly available on registry
May 24, 2017
CompletedStudy Start
First participant enrolled
June 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 5, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 13, 2028
April 30, 2026
October 1, 2025
9.3 years
May 17, 2017
April 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Spleen volume
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)
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 Outcomes (3)
Overall Survival (OS)
until 2.5 years after the date of randomization
Patient Global Impression of Change (PGIC) assessed at Week 24
End of Week 12 to 2 years following Week 24 visit
To compare the safety of pacritinib versus P/C therapy
Randomization through 30 after last treatment
Other Outcomes (15)
SVR of ≥35%
Up to 24 Weeks
Best response in SVR
At 24 Weeks
>25% SVR
From baseline and at Week 24
- +12 more other outcomes
Study Arms (2)
Pacritinib 200 mg BID
EXPERIMENTALTo receive pacritinib 200 mg twice daily (BID) orally, at the same time of day, with or without food
Physician's Choice (P/C) therapy
ACTIVE COMPARATORThe 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.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- 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 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 (see Section 7.1.2.6 for acceptable birth control methods)
- 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
- +1 more criteria
You may not qualify if:
- Life expectancy \<6 months
- Completed allogeneic stem cell transplant or are eligible for and willing to complete other approved available therapy including allogeneic stem cell transplant
- History of splenectomy or planning to undergo splenectomy
- Splenic irradiation within the last 6 months
- Previously treated with pacritinib
- Treatment with any MF-directed therapy within 14 days prior to treatment Day 1
- Prior treatment with more than one JAK2 inhibitor
- 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).
- 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.
- Treatment with an experimental therapy, including MF-directed experimental therapies within 28 days prior to treatment Day 1
- 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
- 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)
- 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.
- 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 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Swedish Orphan Biovitrumlead
- PSI CROcollaborator
Study Sites (207)
University of Alabama at Birmingham, (UAB) Hospital, Comprehensive Cancer Center
Birmingham, Alabama, 35294, United States
Mayo Clinic Hospital
Phoenix, Arizona, 85054, United States
City of Hope
Duarte, California, 91010, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
UCLA David Geffen School of Medicine
Los Angeles, California, 90095, United States
University of Colorado Cancer Center
Aurora, Colorado, 80045, United States
Rocky Mountain Cancer Centers (US Oncology/McKesson)
Boulder, Colorado, 80303, United States
Yale School of Medicine
New Haven, Connecticut, 06510, United States
Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
George Washington University-Medical Faculty Associates
Washington D.C., District of Columbia, 20037, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
The University of Chicago Medical Center
Chicago, Illinois, 60637, United States
University of Kansas Cancer Center and Medical Pavilion
Westwood, Kansas, 66205, United States
Ochsner Medical Center
New Orleans, Louisiana, 70121, United States
Saint Agnes Hospital
Baltimore, Maryland, 21229, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
American Oncology Partners of Maryland, PA
Bethesda, Maryland, 20817, United States
Regional Cancer Care Associates LLC - CCBD Division
Bethesda, Maryland, 20817, United States
Maryland Oncology Hematology, PA- Columbia
Columbia, Maryland, 21044, United States
Michigan Medicine Hematology Clinic-Rogel Cancer Center
Ann Arbor, Michigan, 48109, United States
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49546, United States
Washington University School of Medicine-Siteman Cancer Center
St Louis, Missouri, 63110, United States
Comprehensive Cancer Centers of Nevada- Twain Office
Las Vegas, Nevada, 89169, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Columbia University Medical Center
New York, New York, 10017, United States
Weill Cornell Medical College
New York, New York, 10021, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Memorial Sloan -Kettering Cancer Center
New York, New York, 10065, United States
University of Rochester
Rochester, New York, 14642, United States
Duke University Hospital
Durham, North Carolina, 27710, United States
Cleveland Clinic
Cleveland, Ohio, 44106, United States
The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, 43210, United States
Oregon Health and Science University
Portland, Oregon, 97239-3098, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
The Sarah Cannon Research Institute-Tennessee Oncology
Nashville, Tennessee, 37203, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Mays Cancer Center
San Antonio, Texas, 78229, United States
Texas Oncology- San Antonio
San Antonio, Texas, 78240, United States
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, 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, 80054, France
CHU de Nimes - Hopital Universitaire Caremeau
Nîmes, France, 30900, France
La Conception Hospital
Marseille, France
Hôpital Saint-Louis
Paris, France
CHU Hopitaux de Bordeaux - Hôpital Haut-Lévêque
Pessac, 33604, 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, 3722, 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, G12 0ZD, United Kingdom
Barts Health NHS Trust - The Royal London Hospital
London, United Kingdom, E1 2ES, 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
Related Publications (1)
Gerds AT, Savona MR, Scott BL, Talpaz M, Egyed M, Harrison CN, Yacoub A, Vannucchi A, Mead AJ, Kiladjian JJ, O'Sullivan J, Garcia-Gutierrez V, Bose P, Rampal RK, Miller CB, Palmer J, Oh ST, Buckley SA, Mould DR, Ito K, Tyavanagimatt S, Smith JA, Roman-Torres K, Devineni S, Craig AR, Mascarenhas JO. Determining the recommended dose of pacritinib: results from the PAC203 dose-finding trial in advanced myelofibrosis. Blood Adv. 2020 Nov 24;4(22):5825-5835. doi: 10.1182/bloodadvances.2020003314.
PMID: 33232476DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Simran Singh
Sobi, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2017
First Posted
May 24, 2017
Study Start
June 26, 2017
Primary Completion (Estimated)
October 5, 2026
Study Completion (Estimated)
October 13, 2028
Last Updated
April 30, 2026
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share