Clinical trial NCT03165734: A Phase 3 Study of Pacritinib in Patients with Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Primary Myelofibrosis
Post-polycythemia Vera Myelofibrosis
Post-essential Thrombocythemia Myelofibrosis
Keywords: myelofibrosis
pacritinib
Post-polycythemia Vera Myelofibrosis
Post-essential Thrombocythemia Myelofibrosis
Ruxolitinib
Bone Marrow Disease
Hematologic Diseases
Blood Platelet Disorders
Hemorrhagic Disorders
Splenomegaly
Anemia
Spleen volume
Spleen
Lead sponsor: Swedish Orphan Biovitrum
Sponsor class: INDUSTRY
Collaborators: name: PSI CRO
First posted: 2017-05-24
Enrollment: 399
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: The study is a randomized, controlled phase 3 study comparing the efficacy of pacritinib with P/C therapy in patients with PMF, PPV-MF, or PET-MF (Dynamic International Prognostic Scoring System \[DIPSS\] risk score of Intermediate-1 to High-Risk), who have had had no or limited exposure to any JAK2 inhibitor or are JAK2 inhibitor-naive, and who have severe thrombocytopenia (platelet count \<50,000/µL). This study was designed to use the pacritinib 200 mg BID dose, which was determined to be the optimal dose based on dose- and exposure-response analyses conducted using all available data, including the dosing data from the previous portion of this study. Patients will be randomized 2:1 to receive pacritinib 200 mg BID or the 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. Randomization will be stratified by prior JAK2 inhibitor therapy (yes/no) and P/C therapy selected prior to randomization. Prior JAK2 inhibitor therapy will be defined as any duration of treatment with a JAK2 inhibitor, such as ruxolitinib, fedratinib, or momelotinib. To be eligible, patients are not allowed to have been treated with more than one JAK2 inhibitor. Assigned treatment will continue until the patient experiences progressive disease or intolerable AEs, withdraws consent, or initiates new MF-directed therapy. No study treatment crossover will be allowed at any time. All patients should complete all visit procedures through Week 24, including patients who stop treatment or have protocol-defined progressive disease prior to Week 24, unless the patient withdraws consent for study procedures, dies, undergoes splenic irradiation or splenectomy, initiates any non-protocol-directed anti-MF treatment, or the study is terminated. In addition to the above, patients will be considered to have discontinued treatment if pacritinib or P/C therapy is held for \>28 consecutive days due to treatment toxicity, or if treatment is discontinued for lack of efficacy, or at the request of the principal investigator or the patient. Following the Week 24 assessment, patients who are benefiting from therapy will be allowed to continue receiving the assigned treatment (pacritinib or P/C) until the patient experiences progressive disease, intolerable AEs, withdraws consent, or initiates new MF-directed therapy. All randomized patients will be followed for survival for 2.5 years from the date of randomization unless consent for follow-up is withdrawn.

Eligibility criteria: Diagnosis and Inclusion Criteria

1. Primary MF, post-polycythemia vera MF, or post-essential thrombocythemia MF (as defined by Tefferi and Vardiman 2008
2. Platelet count of \<50,000/μL at Screening (Day -35 to Day -3)
3. Dynamic International Prognostic Scoring System Intermediate-1, Intermediate-2, or High-Risk (Passamonti et al 2010
4. Palpable splenomegaly ≥5 cm below the lower costal margin (LCM) in the midclavicular line as assessed by physical examination
5. 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.
6. Age ≥18 years
7. Eastern Cooperative Oncology Group performance status 0 to 2
8. Peripheral blast count of \<10% throughout the Screening period prior to randomization
9. Absolute neutrophil count of ≥500/µL
10. Left ventricular cardiac ejection fraction of ≥50% by echocardiogram or multigated acquisition scan
11. 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
12. Adequate coagulation defined by prothrombin time/international normalized ratio and partial thromboplastin time ≤1.5 × ULN
13. If fertile, willing to use highly effective birth control methods during the study
14. Willing to undergo and able to tolerate frequent MRI or CT scan assessments during the study
15. Able to understand and willing to complete symptom assessments using a patient-reported outcome instrument
16. Provision of signed informed consent

Exclusion Criteria

1. Life expectancy \<6 months
2. Completed allogeneic stem cell transplant (allo-SCT) or are eligible for and willing to complete other approved available therapy including allogeneic stem cell
3. History of splenectomy or planning to undergo splenectomy
4. Splenic irradiation within the last 6 months
5. Previously treated with pacritinib
6. Treatment with any MF-directed therapy within 14 days prior to treatment Day 1
7. Prior treatment with more than one JAK2 inhibitor
8. 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).
9. 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.
10. Treatment with an experimental therapy, including MF-directed experimental therapies within 28 days prior to treatment Day 1
11. Systemic treatment with a strong 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
12. 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)
13. 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.
14. 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. Any history of CTCAE grade ≥2 non-dysrhythmia cardiac conditions within 6 months prior to treatment Day 1. Patients with asymptomatic grade 2 non-dysrhythmia cardiovascular conditions may be considered for inclusion, with the approval of the Medical Monitor, if stable and unlikely to affect patient safety.
16. Any history of CTCAE grade ≥2 cardiac dysrhythmias within 6 months prior to treatment Day 1. Patients with non-corrected QT interval CTCAE grade 2 cardiac dysrhythmias may be considered for inclusion, with the approval of the Medical Monitor, if the dysrhythmias are stable, asymptomatic, and unlikely to affect patient safety.
17. QT corrected by the Fridericia method (QTcF) prolongation \>450 ms or other factors that increase the risk for QT interval prolongation (eg, hypokalemia \[defined as serum potassium \<3.0 mEq/L that is persistent and refractory to correction\], or history of long QT interval syndrome).
18. New York Heart Association Class II, III, or IV congestive heart failure
19. Any active gastrointestinal or metabolic condition that could interfere with absorption of oral medication
20. Active or uncontrolled inflammatory or chronic functional bowel disorder such as Crohn's Disease, inflammatory bowel disease, chronic diarrhea, or chronic constipation
21. Other malignancy within 3 years prior to treatment Day 1. The following patients may be eligible despite having had a malignancy within the prior 3 years: patients with curatively treated squamous or basal cell carcinoma of the skin; patients with curatively treated non-invasive cancers; patients with organ-confined prostate cancer with prostate specific antigen (PSA) \<20 ng/mL and National Comprehensive Cancer Network risk of Very Low, Low, or Favorable Intermediate; and patients with curatively treated non-metastatic prostate cancer with negative PSA.
22. Uncontrolled intercurrent illness, including, but not limited to, ongoing active infection, psychiatric illness, or social situation that, in the judgment of the treating physician, would limit compliance with study requirements
23. Known seropositivity for human immunodeficiency (HIV) virus. For patients in France, Czech Republic, and Italy only: testing for HIV is required during Screening.
24. Known active hepatitis A, B, or C virus infection. For patients in France, Czech Republic and Italy only: testing for hepatitis B and C is required during Screening.
25. Women who are pregnant or lactating
26. Concurrent enrollment in another interventional trial
27. Severe thrombocytopenia due to vitamin B12 deficiency, folate deficiency, or viral infection in the opinion of the investigator
28. Known hypersensitivity to pacritinib or any of the following inactive ingredients: microcrystalline cellulose, polyethylene glycol, and magnesium stearate; any contraindication to the "physician's choice" medicinal product selected by the investigator to be used as the comparator or to loperamide or equivalent antidiarrheal medication
29. Persons deprived of their liberty by a judicial or administrative decision
30. Persons subject to legal protection measures or unable to express their consent
31. Temporarily incapacitated persons

Primary outcomes:
measure: Spleen volume
timeFrame: From baseline at 24 weeks
measure: Total Symptom Score (TSS) (excluding tiredness)
timeFrame: From baseline at Week 24
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: until 2.5 years after the date of randomization
measure: Patient Global Impression of Change (PGIC) assessed at Week 24
timeFrame: End of Week 12 to 2 years following Week 24 visit
measure: To compare the safety of pacritinib versus P/C therapy
timeFrame: Randomization through 30 after last treatment
Other outcomes:
measure: SVR of ≥35%
timeFrame: Up to 24 Weeks
measure: Best response in SVR
timeFrame: At 24 Weeks
measure: >25% SVR
timeFrame: From baseline and at Week 24
measure: Red blood cell (RBC)
timeFrame: Baseline to End of Treatment
measure: hemoglobin level
timeFrame: Weeks 12 and 24
measure: platelet count
timeFrame: Weeks 12 and 24
measure: platelet transfusions
timeFrame: Weeks 12 and 24
measure: PROMIS
timeFrame: Baseline to Week 24
measure: Leukemia-free survival (LFS)
timeFrame: Baseline to Week 24
measure: The percentage of red blood cell transfusion-independent patients achieving a 1 g/dL and a 2 g/dL increase in hemoglobin
timeFrame: Baseline to 24 weeks
measure: The percentage of platelet transfusion-independent patients with improvement in grade of thrombocytopenia
timeFrame: Baseline to 24 weeks
measure: The percentage of transfusion-dependent patients achieving transfusion independence and achieving 50% reduction in transfusion rate
timeFrame: Baseline to 24 weeks
measure: Hemoglobin A1c
timeFrame: Baseline to Week 24
measure: mutated allelic burden, gene expression, and pharmacodynamic (PD) biomarkers
timeFrame: Baseline to up to 24 Weeks
measure: The proportion of patients who experience a major adverse cardiac event (MACE)
timeFrame: Baseline to up to 24 Weeks
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham, (UAB) Hospital, Comprehensive Cancer Center
state: Alabama
city: Phoenix
country: United States
facility: Mayo Clinic Hospital
state: Arizona
city: Duarte
country: United States
facility: City of Hope
state: California
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
city: Los Angeles
country: United States
facility: UCLA David Geffen School of Medicine
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Boulder
country: United States
facility: Rocky Mountain Cancer Centers (US Oncology/McKesson)
state: Colorado
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
city: Washington
country: United States
facility: George Washington University-Medical Faculty Associates
state: District of Columbia
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
city: Westwood
country: United States
facility: University of Kansas Cancer Center and Medical Pavilion
state: Kansas
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: Saint Agnes Hospital
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Bethesda
country: United States
facility: American Oncology Partners of Maryland, PA
state: Maryland
city: Bethesda
country: United States
facility: Regional Cancer Care Associates LLC - CCBD Division
state: Maryland
city: Columbia
country: United States
facility: Maryland Oncology Hematology, PA- Columbia
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Institute, Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Medicine Hematology Clinic-Rogel Cancer Center
state: Michigan
city: Grand Rapids
country: United States
facility: Cancer and Hematology Centers of Western Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine-Siteman Cancer Center
state: Missouri
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada- Twain Office
state: Nevada
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Memorial Sloan -Kettering Cancer Center
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The James Cancer Hospital and Solove Research Institute
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
city: Nashville
country: United States
facility: The Sarah Cannon Research Institute-Tennessee Oncology
state: Tennessee
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Mays Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology- San Antonio
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah - Huntsman Cancer Institute
state: Utah
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Sydney
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Melbourne
country: Australia
facility: Alfred Hospital, Malignant Hematology and Stem Cell Transplantation Service
state: Victoria
city: Perth
country: Australia
facility: The Perth Blood Institute
state: Western Australia
city: Gomel
country: Belarus
facility: Republican Research Center for Radiation Medicine and Human Ecology
city: Grodno
country: Belarus
facility: Grodno University Hospital
city: Minsk
country: Belarus
facility: Minsk Scientific and Practical Center of Surgery, Transplantology and Hematology
city: Banja Luka
country: Bosnia and Herzegovina
facility: University Clinical Centre of the Republic of Srpska
city: Sarajevo
country: Bosnia and Herzegovina
facility: University Clinical Center of Sarajevo
city: Pleven
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski"
city: Plovdiv
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment - Sofia, part of Military Medical Academy
city: Sofia
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Hematological Diseases
city: Varna
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment "Sveta Marina"
city: Calgary
country: Canada
facility: Tom Baker Cancer Center, Internal Medicine/Hematology
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Vancouver
country: Canada
facility: Providence Hematology - Vancouver
state: British Columbia
city: Saint John's
country: Canada
facility: Eastern Regional Health Authority
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Nova Scotia Health Authority, Centre for Clinical Research
state: Nova Scotia
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital; Clinical Research Unit
state: Quebec
city: Brno
country: Czechia
facility: University Hospital Brno
city: Olomouc
country: Czechia
facility: University Hospital Olomouc
city: Pilsen
country: Czechia
facility: University Hospital Plzen
city: Prague
country: Czechia
facility: University Hospital Kralovske Vinohrady, Clinic of Internal Hematology
city: Amiens
country: France
facility: CHU Hôpital Amiens Sud
city: Marseille
country: France
facility: La Conception Hospital
city: Nîmes
country: France
facility: CHU de Nimes - Hopital Universitaire Caremeau
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Pessac
country: France
facility: CHU Hopitaux de Bordeaux - Hôpital Haut-Lévêque
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon-Sud
city: Poitiers
country: France
facility: University Hospital Center of Poitiers
city: Strasbourg
country: France
facility: Hautepierre Hospital
city: Toulouse
country: France
facility: Centre Hospitalier de Toulouse- Hôpital Purpan
city: Tbilisi
country: Georgia
facility: JSC K. Eristavi National Center For Experimental and Clinical Surgery
city: Tbilisi
country: Georgia
facility: LTD M.Zodelava's Hematology Center, Department of Hematology
city: Tbilisi
country: Georgia
facility: LTD National Institute of Endocrinology
city: Tbilisi
country: Georgia
facility: LTD S.Khechinashvili University Hospital
city: Tbilisi
country: Georgia
facility: Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LTD
city: Tbilisi
country: Georgia
facility: Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC
city: Cologne
country: Germany
facility: University Hospital Cologne, Department of Internal Medicine I,
city: Halle
country: Germany
facility: University Hospital Halle (Saale), Department of Internal Medicine IV - Hematology and Oncology
city: Minden
country: Germany
facility: Johannes Wesling Hospital Minden, Department of Oncology and Hematology
city: Munich
country: Germany
facility: Hospital rechts der Isar, Department of Internal Medicine III, Hematology and Oncology
city: Ulm
country: Germany
facility: University Hospital Ulm, Center for Internal Medicine,
city: Budapest
country: Hungary
facility: Semmelweis University SE ÁOK I. sz. Belgyógyászati Klinika
city: Debrecen
country: Hungary
facility: University of Debrecen Clinical Center (Debreceni Egyetem Klinikai Központ)
city: Kaposvár
country: Hungary
facility: Somogy Megyei Kaposi Mór Oktató Kórház
city: Kecskemét
country: Hungary
facility: Bacs-Kiskun County Hospital, 2nd Department of Internal Medicine
city: Nyíregyháza
country: Hungary
facility: Szabolcs-Szatmar-Bereg County Hospitals and University Teaching Hospital, Department of Hematology
city: Székesfehérvár
country: Hungary
facility: Fejer County St. Gyorgy University Teaching Hospital, Department of Internal Medicine I
city: Guwahati
country: India
facility: Gauhati Medical College and Hospital
state: Assam
city: Pune
country: India
facility: Sahyadri Super Speciality Hospital
state: Maharashtra
city: Jaipur
country: India
facility: Shri Ram Cancer Centre, Mahatma Gandhi Medical College & Hospital
state: Rajasthan
city: Kolkata
country: India
facility: Tata Medical Center
state: West Bengal
city: Bengaluru
country: India
facility: St. John's Medical College Hospital
city: Haifa
country: Israel
facility: Lady Davis Carmel Medical Center, Department of Hematology,
city: Jerusalem
country: Israel
facility: Hadassah Medical Center, Department of Hematology,
city: Kfar Saba
country: Israel
facility: Meir Medical Center, Hematology Institute and Blood Bank
city: Petah-Tikva
country: Israel
facility: Rabin Medical Center, Clinic for Myeloproliferative Disorders
city: Tel Aviv
country: Israel
facility: The Tel Aviv Sourasky Medical Center, Department of Internal Medicine
city: Bari
country: Italy
facility: Cancer Institute "Giovanni Paolo II", IRCCS
city: Bologna
country: Italy
facility: Polyclinic S. Orsola-Malpighi
city: Brescia
country: Italy
facility: ASST Spedali Civili Brescia, Hematology Unit
city: Florence
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi
city: Forlì
country: Italy
facility: Scientific Institute of Romagna for the Study and Treatment of Cancer (IRST), IRCCS
city: Milan
country: Italy
facility: Maggiore Polyclinic Hospital, Fondazione IRCCS Ca' Granda
city: Monza
country: Italy
facility: ASST Monza - Ospedale San Gerardo
city: Naples
country: Italy
facility: University Hospital "Federico II"
city: Novara
country: Italy
facility: University Hospital "Maggiore della Carita" of Novara
city: Palermo
country: Italy
facility: United Hospitals Villa Sofia Cervello
city: Pavia
country: Italy
facility: Polyclinic San Matteo, IRCCS
city: Rimini
country: Italy
facility: Hospital "Infermi" of Rimini
city: Rome
country: Italy
facility: Umberto I Polyclinic of Rome
city: Rome
country: Italy
facility: University Polyclinic Foundation "Agostino Gemelli"
city: Turin
country: Italy
facility: City of Health and Science of Turin
city: Udine
country: Italy
facility: Santa Maria della Misericordia University Hospital of Udine
city: Varese
country: Italy
facility: ASST Sette Laghi Hospital
city: Aktobe
country: Kazakhstan
facility: Aktobe Medical Center, Department of Hematology
city: Almaty
country: Kazakhstan
facility: City Clinical Hospital #7, Hematology Department
city: Karaganda
country: Kazakhstan
facility: Hematology Center
city: Shymkent
country: Kazakhstan
facility: City Oncological Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
state: South Korea
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, St. Mary's Hospital
city: Białystok
country: Poland
facility: University Teaching Hospital in Bialystok
city: Gdańsk
country: Poland
facility: University Clinical Center in Gdansk
city: Katowice
country: Poland
facility: Andrzej Mielecki Independent Public Clinical Hospital of Medical University of Silesia in Katowice, Department of Hematology and Bone Marrow Transplantation
city: Katowice
country: Poland
facility: Pratia Oncology Katowice
city: Kraków
country: Poland
facility: University Hospital in Krakow
city: Lublin
country: Poland
facility: Independent Public Teaching Hospital No.1 in Lublin, Department of Hematooncology, Bone Marrow Transplantation and Chemotherapy
city: Nowy Sącz
country: Poland
facility: Jedrzej Sniadecki Specialist Hospital in Nowy Sacz, Department of Hematology
city: Rzeszów
country: Poland
facility: Frederic Chopin Provincial Teaching Hospital No. 1 in Rzeszow, Department of Hematology,
city: Toruń
country: Poland
facility: Nasz Lekarz Medical Outpatient Clinics Slawomir Jeka
city: Warsaw
country: Poland
facility: Institute of Hematology and Transfusion Medicine, Teaching Department of Hematology
city: Wrocław
country: Poland
facility: Jan Mikulicz Radecki University Hospital in Wroclaw, Department and Clinic of Hematology, Blood Neoplasms and Bone Marrow Transplantation
city: Łódź
country: Poland
facility: Nicolaus Copernicus Provincial Multispecialty Oncology and Traumatology Center in Lodz
city: Braşov
country: Romania
facility: Onco Card Srl
city: Bucharest
country: Romania
facility: Coltea Clinical Hospital
city: Bucharest
country: Romania
facility: Fundeni Clinical Institute
city: Cluj-Napoca
country: Romania
facility: Prof. Dr. Ion Chiricuta" Institute of Oncology
city: Moscow
country: Russian Federation
facility: City Clinical Hospital #40
city: Moscow
country: Russian Federation
facility: City Clinical Hospital n.a. V.V. Veresaev of the Moscow City Health
city: Moscow
country: Russian Federation
facility: S.P. Botkin City Clinical Hospital
city: Pyatigorsk
country: Russian Federation
facility: Clinic UZI 4D, LLC
city: Saint Petersburg
country: Russian Federation
facility: Research Institute of Hematology and Transfusiology
city: Saint Petersburg
country: Russian Federation
facility: S.M. Kirov Military Medical Academy, Department and Clinic for Intermediate-Level Training in Internal Medicine, Hematology Division
city: Saint Petersburg
country: Russian Federation
facility: V.A. Almazov North-West Federal Medical Research Center, Institute of Oncology and Hematology, Scientific Department of Clinical Oncology
city: Samara
country: Russian Federation
facility: V.D. Seredavin Samara Regional Clinical Hospital, Department of Hematology
city: Ufa
country: Russian Federation
facility: Bashkiria State Medical University, Department of Internal Medicine
city: Volgograd
country: Russian Federation
facility: Volgograd Regional Clinical Oncology Center
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia, Clinic of Hematology
city: Novi Sad
country: Serbia
facility: Clinical Center of Vojvodina, Clinic of Hematology
city: Barcelona,
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Barcelona
country: Spain
facility: University Hospital Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: University Hospital 12 de Octubre, Department of Hematology
city: Murcia
country: Spain
facility: Morales Meseguer University General Hospital, Department of Hematology and Hemotherapy
city: Pamplona
country: Spain
facility: Clínica Universidad de Navarra
city: Salamanca
country: Spain
facility: University Clinical Hospital of Salamanca, Department of Hematology
city: Seville
country: Spain
facility: University Hospital Virgen del Rocio (HUVR)
city: Valencia
country: Spain
facility: University Clinical Hospital of Valencia, Department of Hematology and Medical Oncology
city: Cherkasy
country: Ukraine
facility: Cherkasy Regional Oncology Dispensary of Cherkasy Oblast Council, Regional Treatment and Diagnostic Hematology Center, Department of Hematology
city: Dnipro
country: Ukraine
facility: City Clinical Hospital #4" under Dnipro City Council
city: Ivano-Frankivs'k
country: Ukraine
facility: Regional Clinical Hospital, Department of Hematology,
city: Kharkiv
country: Ukraine
facility: Communal Non-profit enterprise "Regional Center of Oncology", Department of Hematology
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital #9, Hematology Department #1
city: Kyiv
country: Ukraine
facility: Kyiv Regional Oncology Center, Department of Hematology,
city: Kyiv
country: Ukraine
facility: Limited Liability Company "City Doctor"
city: Lviv
country: Ukraine
facility: Institute of Blood Pathology and Transfusion Medicine, Department of Hematology
city: Poltava
country: Ukraine
facility: Poltava M.V. Sklifosovskyi Regional Clinical Hospital under Poltava Regional Council, Department of Hematology
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital, Department of Hematology
state: South Yorkshire
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
city: Gloucester
country: United Kingdom
facility: Gloucestershire Royal Hospital
city: London
country: United Kingdom
facility: Barts Health NHS Trust - The Royal London Hospital
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust - Hammersmith Hospital
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Trust - Churchill Hospital
Study officials:
affiliation: Sobi, Inc.
name: Simran Singh
role: STUDY_DIRECTOR
References:
citation: 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.