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

Primary Purpose

Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pacritinib
Physician's Choice medications
Sponsored by
CTI BioPharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Myelofibrosis focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Diagnosis and Inclusion Criteria

  1. PMF (including pre-fibrotic MF), PPV-MF, or PET-MF (Tefferi and Vandiman 2008)
  2. Average platelet count of <50,000/µL at Screening (Day -35 to Day -3) based on two measurements taken on different days; both measurements must be <50,000/µL
  3. DIPSS 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

  6. If the patient has received prior JAK2 inhibitor treatment, this treatment must meet at least one of the following criteria:

    1. Prior treatment with any JAK2 inhibitor, irrespective of dose, with a duration of 90 days or less. 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 during that interval.
    2. Prior treatment with ruxolitinib, at no more than 10 mg total daily dose on any day, with a duration of 270 days or less. The 270-day period starts on the date of first ruxolitinib administration and continues for 270 calendar days, regardless of whether therapy is administered continuously or intermittently during that interval.The patient may not have received >10 mg of ruxolitinib on any day during that interval
  7. Age ≥18 years
  8. Eastern Cooperative Oncology Group performance status 0 to 2
  9. Peripheral blast count of <10% throughout the Screening period and at baseline
  10. Absolute neutrophil count of ≥500/µL
  11. Left ventricular cardiac ejection fraction of ≥50% by echocardiogram or multigated acquisition (MUGA) scan
  12. 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
  13. Adequate coagulation defined by prothrombin time/international normalized ratio and partial thromboplastin time ≤1.5 × ULN
  14. If fertile, willing to use effective birth control methods during the study
  15. Willing to undergo and able to tolerate frequent MRI or CT scan assessments during the study
  16. Able to understand and willing to complete symptom assessments using a patient-reported outcome instrument
  17. 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 allo-SCT
  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. Any prior treatment with more than one JAK2 inhibitor
  8. Treatment with an experimental therapy within 28 days prior to treatment Day 1
  9. Systemic treatment with a strong CYP3A4 inhibitor or a strong cytochrome P450 (CYP450) 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
  10. 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 (e.g., surgery, trauma, or injury)
  11. Systemic treatment with medications that increase the risk of bleeding, including anticoagulants, antiplatelet agents (except for aspirin dosages of ≤100 mg per day), anti-vascular endothelial growth factor (anti-vascular endothelial growth factor [anti-VEGF]) agents, and daily use of cyclooxygenase-1 (COX-1) inhibiting nonsteroidal anti- inflammatory drugs (NSAIDs) within 14 days prior to treatment Day 1
  12. 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
  13. 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.
  14. Any history of CTCAE grade ≥2 cardiac dysrhythmias within 6 months prior to treatment Day 1. Patients with non-QTc 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.
  15. QT corrected by the Fridericia method (QTcF) prolongation >450 ms or other factors that increase the risk for QT interval prolongation (e.g., hypokalemia [defined as serum potassium <3.0 mEq/L that is persistent and refractory to correction], or history of long QT interval syndrome
  16. New York Heart Association Class II, III, or IV congestive heart failure
  17. Any active gastrointestinal or metabolic condition that could interfere with absorption of oral medication
  18. Active or uncontrolled inflammatory or chronic functional bowel disorder such as Crohn's Disease, inflammatory bowel disease, chronic diarrhea, or chronic constipation
  19. 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.
  20. 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
  21. Known seropositivity for human immunodeficiency virus
  22. Known active hepatitis A, B, or C virus infection
  23. Women who are pregnant or lactating
  24. Concurrent enrollment in another interventional trial
  25. Severe thrombocytopenia due to vitamin B12 deficiency, folate deficiency, or viral infection in the opinion of the investigator
  26. 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.

Sites / Locations

  • University of Alabama at Birmingham, (UAB) Hospital, Comprehensive Cancer Center
  • Mayo Clinic Hospital
  • City of Hope
  • USC Norris Comprehensive Cancer Center
  • UCLA David Geffen School of Medicine
  • University of Colorado Cancer Center
  • Rocky Mountain Cancer Centers (US Oncology/McKesson)
  • Yale School of Medicine
  • Georgetown University Hospital
  • George Washington University-Medical Faculty Associates
  • Cleveland Clinic Florida
  • Northwestern Memorial Hospital
  • Rush University Medical Center
  • The University of Chicago Medical Center
  • University of Kansas Cancer Center and Medical Pavilion
  • Ochsner Medical Center
  • Saint Agnes Hospital
  • Johns Hopkins University
  • American Oncology Partners of Maryland, PA
  • Regional Cancer Care Associates LLC - CCBD Division
  • Maryland Oncology Hematology, PA- Columbia
  • Dana Farber Cancer Institute, Massachusetts General Hospital
  • Michigan Medicine Hematology Clinic-Rogel Cancer Center
  • Cancer and Hematology Centers of Western Michigan
  • Washington University School of Medicine-Siteman Cancer Center
  • Comprehensive Cancer Centers of Nevada- Twain Office
  • Hackensack University Medical Center
  • Memorial Sloan-Kettering Cancer Center- Commack
  • Columbia University Medical Center
  • Weill Cornell Medical College
  • Icahn School of Medicine at Mount Sinai
  • Memorial Sloan -Kettering Cancer Center
  • University of Rochester
  • Duke University Hospital
  • Cleveland Clinic
  • Ohio State University Comprehensive Cancer Center
  • Oregon Health and Science University
  • UPMC Hillman Cancer Center
  • The Sarah Cannon Research Institute-Tennessee Oncology
  • The University of Texas MD Anderson Cancer Center
  • Mays Cancer Center
  • Texas Oncology- San Antonio
  • University of Utah - Huntsman Cancer Institute
  • Fred Hutchinson Cancer Research Center
  • Westmead HospitalRecruiting
  • Alfred Hospital, Malignant Hematology and Stem Cell Transplantation ServiceRecruiting
  • The Perth Blood InstituteRecruiting
  • Republican Research Center for Radiation Medicine and Human EcologyRecruiting
  • Grodno University Hospital
  • Minsk Scientific and Practical Center of Surgery, Transplantology and HematologyRecruiting
  • University Clinical Centre of the Republic of SrpskaRecruiting
  • University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski"Recruiting
  • University Multiprofile Hospital for Active Treatment "Sveti Georgi", PlovdivRecruiting
  • Multiprofile Hospital for Active Treatment - Sofia, part of Military Medical AcademyRecruiting
  • Specialized Hospital for Active Treatment of Hematological DiseasesRecruiting
  • Multiprofile Hospital for Active Treatment "Sveta Marina"Recruiting
  • Tom Baker Cancer Center, Internal Medicine/HematologyRecruiting
  • University of AlbertaRecruiting
  • Providence Hematology - VancouverRecruiting
  • Eastern Regional Health AuthorityRecruiting
  • Nova Scotia Health Authority, Centre for Clinical ResearchRecruiting
  • Princess Margaret Cancer CentreRecruiting
  • Jewish General Hospital; Clinical Research UnitRecruiting
  • University Hospital BrnoRecruiting
  • University Hospital OlomoucRecruiting
  • University Hospital PlzenRecruiting
  • University Hospital Kralovske Vinohrady, Clinic of Internal HematologyRecruiting
  • CHU Hôpital Amiens SudRecruiting
  • La Conception HospitalRecruiting
  • CHU de Nimes - Hopital Universitaire CaremeauRecruiting
  • Hôpital Saint-LouisRecruiting
  • CHU Hopitaux de Bordeaux - Hôpital Haut-LévêqueRecruiting
  • Centre Hospitalier Lyon-SudRecruiting
  • University Hospital Center of PoitiersRecruiting
  • Hautepierre Hospital
  • Centre Hospitalier de Toulouse- Hôpital Purpan
  • JSC K. Eristavi National Center For Experimental and Clinical SurgeryRecruiting
  • LTD M.Zodelava's Hematology Center, Department of HematologyRecruiting
  • LTD National Institute of Endocrinology
  • LTD S.Khechinashvili University Hospital
  • Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LTDRecruiting
  • Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLCRecruiting
  • University Hospital Cologne, Department of Internal Medicine I,
  • University Hospital Halle (Saale), Department of Internal Medicine IV - Hematology and Oncology
  • Johannes Wesling Hospital Minden, Department of Oncology and Hematology
  • Hospital rechts der Isar, Department of Internal Medicine III, Hematology and Oncology
  • University Hospital Ulm, Center for Internal Medicine,
  • Semmelweis University SE ÁOK I. sz. Belgyógyászati KlinikaRecruiting
  • University of Debrecen Clinical Center (Debreceni Egyetem Klinikai Központ)Recruiting
  • Somogy Megyei Kaposi Mór Oktató KórházRecruiting
  • Bacs-Kiskun County Hospital, 2nd Department of Internal Medicine
  • Szabolcs-Szatmar-Bereg County Hospitals and University Teaching Hospital, Department of HematologyRecruiting
  • Fejer County St. Gyorgy University Teaching Hospital, Department of Internal Medicine IRecruiting
  • Lady Davis Carmel Medical Center, Department of Hematology,Recruiting
  • Hadassah Medical Center, Department of Hematology,Recruiting
  • Meir Medical Center, Hematology Institute and Blood BankRecruiting
  • Rabin Medical Center, Clinic for Myeloproliferative DisordersRecruiting
  • The Tel Aviv Sourasky Medical Center, Department of Internal MedicineRecruiting
  • Cancer Institute "Giovanni Paolo II", IRCCSRecruiting
  • Polyclinic S. Orsola-MalpighiRecruiting
  • ASST Spedali Civili Brescia, Hematology UnitRecruiting
  • Azienda Ospedaliero-Universitaria CareggiRecruiting
  • Scientific Institute of Romagna for the Study and Treatment of Cancer (IRST), IRCCSRecruiting
  • Maggiore Polyclinic Hospital, Fondazione IRCCS Ca' GrandaRecruiting
  • ASST Monza - Ospedale San GerardoRecruiting
  • United Hospitals Villa Sofia CervelloRecruiting
  • Polyclinic San Matteo, IRCCSRecruiting
  • Hospital "Infermi" of Rimini
  • University Polyclinic Foundation "Agostino Gemelli"Recruiting
  • ASST Sette Laghi HospitalRecruiting
  • Pusan National University HospitalRecruiting
  • Kyungpook National University HospitalRecruiting
  • Severance HospitalRecruiting
  • Samsung Medical CenterRecruiting
  • Seoul National University HospitalRecruiting
  • The Catholic University of Korea, St. Mary's HospitalRecruiting
  • University Clinical Center in GdanskRecruiting
  • Andrzej Mielecki Independent Public Clinical Hospital of Medical University of Silesia in Katowice, Department of Hematology and Bone Marrow TransplantationRecruiting
  • Pratia Oncology KatowiceRecruiting
  • University Hospital in KrakowRecruiting
  • Jedrzej Sniadecki Specialist Hospital in Nowy Sacz, Department of HematologyRecruiting
  • Frederic Chopin Provincial Teaching Hospital No. 1 in Rzeszow, Department of Hematology,Recruiting
  • Nasz Lekarz Medical Outpatient Clinics Slawomir JekaRecruiting
  • Institute of Hematology and Transfusion Medicine, Teaching Department of HematologyRecruiting
  • Jan Mikulicz Radecki University Hospital in Wroclaw, Department and Clinic of Hematology, Blood Neoplasms and Bone Marrow TransplantationRecruiting
  • Nicolaus Copernicus Provincial Multispecialty Oncology and Traumatology Center in LodzRecruiting
  • Onco Card SrlRecruiting
  • Coltea Clinical HospitalRecruiting
  • Fundeni Clinical InstituteRecruiting
  • Prof. Dr. Ion Chiricuta" Institute of OncologyRecruiting
  • City Clinical Hospital #40
  • City Clinical Hospital n.a. V.V. Veresaev of the Moscow City Health
  • S.P. Botkin City Clinical Hospital
  • Clinic UZI 4D, LLC
  • Research Institute of Hematology and Transfusiology
  • S.M. Kirov Military Medical Academy, Department and Clinic for Intermediate-Level Training in Internal Medicine, Hematology Division
  • V.A. Almazov North-West Federal Medical Research Center, Institute of Oncology and Hematology, Scientific Department of Clinical Oncology
  • V.D. Seredavin Samara Regional Clinical Hospital, Department of Hematology
  • Bashkiria State Medical University, Department of Internal Medicine
  • Volgograd Regional Clinical Oncology Center
  • Clinical Center of Serbia, Clinic of HematologyRecruiting
  • Clinical Center of Vojvodina, Clinic of HematologyRecruiting
  • Hospital del MarRecruiting
  • Hospital Clínic de BarcelonaRecruiting
  • Hospital Universitario Ramón y CajalRecruiting
  • Morales Meseguer University General Hospital, Department of Hematology and HemotherapyRecruiting
  • Clínica Universidad de Navarra
  • University Clinical Hospital of Salamanca, Department of HematologyRecruiting
  • University Clinical Hospital of Valencia, Department of Hematology and Medical OncologyRecruiting
  • Cherkasy Regional Oncology Dispensary of Cherkasy Oblast Council, Regional Treatment and Diagnostic Hematology Center, Department of Hematology
  • City Clinical Hospital #4" under Dnipro City Council
  • Regional Clinical Hospital, Department of Hematology,
  • Communal Non-profit enterprise "Regional Center of Oncology", Department of Hematology
  • Kyiv City Clinical Hospital #9, Hematology Department #1
  • Kyiv Regional Oncology Center, Department of Hematology,
  • Limited Liability Company "City Doctor"
  • Institute of Blood Pathology and Transfusion Medicine, Department of Hematology
  • Poltava M.V. Sklifosovskyi Regional Clinical Hospital under Poltava Regional Council, Department of Hematology
  • Royal Hallamshire Hospital, Department of HematologyRecruiting
  • Beatson West of Scotland Cancer CentreRecruiting
  • Gloucestershire Royal HospitalRecruiting
  • Barts Health NHS Trust - The Royal London HospitalRecruiting
  • Guy's and St Thomas' NHS Foundation Trust - Guy's HospitalRecruiting
  • Imperial College Healthcare NHS Trust - Hammersmith HospitalRecruiting
  • The Christie NHS Foundation Trust
  • Oxford University Hospitals NHS Trust - Churchill HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pacritinib 200 mg BID

Physician's Choice (P/C) therapy

Arm Description

To receive pacritinib 200 mg twice daily (BID) orally, at the same time of day, with or without food

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.

Outcomes

Primary Outcome Measures

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
Total Symptom Score (TSS)
To compare the efficacy of pacritinib with 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)

Secondary Outcome Measures

Overall Survival (OS)
To compare the overall survival (OS) of patients treated with pacritinib versus those treated with P/C
Patient Global Impression of Change (PGIC) assessed at Week 24
To compare the percentage of patients who self-assess as "very much improved" or "much improved" as measured by the Patient Global Impression of Change (PGIC) in patients treated with pacritinib versus those treated with P/C
To compare the safety of pacritinib versus P/C therapy
Safety will be assessed based on the incidence and severity (according to the Common Terminology Criteria for Adverse Events) of treatment emergent adverse events from the time of randomization until 30 days after completion of treatment with pacritinib and/or physician's choice therapy.

Full Information

First Posted
May 17, 2017
Last Updated
October 5, 2023
Sponsor
CTI BioPharma
Collaborators
PSI CRO
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1. Study Identification

Unique Protocol Identification Number
NCT03165734
Brief Title
A Phase 3 Study of Pacritinib in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis
Acronym
PACIFICA
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 26, 2017 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CTI BioPharma
Collaborators
PSI CRO

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
399 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pacritinib 200 mg BID
Arm Type
Experimental
Arm Description
To receive pacritinib 200 mg twice daily (BID) orally, at the same time of day, with or without food
Arm Title
Physician's Choice (P/C) therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Pacritinib
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Physician's Choice medications
Other Intervention Name(s)
corticosteroids, hydroxyurea, danazol, low-dose ruxolitinib
Intervention Description
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.
Primary Outcome Measure Information:
Title
Spleen volume
Description
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
Time Frame
From baseline at 24 weeks
Title
Total Symptom Score (TSS)
Description
To compare the efficacy of pacritinib with 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)
Time Frame
From baseline at Week 24
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
To compare the overall survival (OS) of patients treated with pacritinib versus those treated with P/C
Time Frame
until 2.5 years after the date of randomization
Title
Patient Global Impression of Change (PGIC) assessed at Week 24
Description
To compare the percentage of patients who self-assess as "very much improved" or "much improved" as measured by the Patient Global Impression of Change (PGIC) in patients treated with pacritinib versus those treated with P/C
Time Frame
End of Week 12 to 2 years following Week 24 visit
Title
To compare the safety of pacritinib versus P/C therapy
Description
Safety will be assessed based on the incidence and severity (according to the Common Terminology Criteria for Adverse Events) of treatment emergent adverse events from the time of randomization until 30 days after completion of treatment with pacritinib and/or physician's choice therapy.
Time Frame
Randomization through 30 after last treatment
Other Pre-specified Outcome Measures:
Title
SVR of ≥35%
Description
Time to achievement of SVR of ≥35%
Time Frame
Up to 24 Weeks
Title
Best response in SVR
Description
Best response in SVR by MRI or CT scan
Time Frame
At 24 Weeks
Title
>25% SVR
Description
Proportion of patients achieving >25% SVR
Time Frame
From baseline and at Week 24
Title
Red blood cell (RBC)
Description
Achievement of red blood cell (RBC) transfusion independence at Weeks 12 and 24
Time Frame
Baseline to End of Treatment
Title
hemoglobin level
Description
Improvement in hemoglobin level without transfusion at Weeks 12 and 24
Time Frame
Weeks 12 and 24
Title
platelet count
Description
Improvement in platelet count at Weeks 12 and 24
Time Frame
Weeks 12 and 24
Title
platelet transfusions
Description
Frequency of platelet transfusions at Weeks 12 and 24
Time Frame
Weeks 12 and 24
Title
PROMIS
Description
Improvement in fatigue as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) v.1.0 - Fatigue from Baseline through Week 24
Time Frame
Baseline to Week 24
Title
Leukemia-free survival (LFS)
Description
Leukemia-free survival (LFS) of patients treated with pacritinib versus P/C therapy
Time Frame
Baseline to Week 24
Title
The percentage of red blood cell transfusion-independent patients achieving a 1 g/dL and a 2 g/dL increase in hemoglobin
Description
The percentage of red blood cell transfusion-independent patients at baseline achieving a 1 g/dL and a 2 g/dL increase in hemoglobin at week 24
Time Frame
Baseline to 24 weeks
Title
The percentage of platelet transfusion-independent patients with improvement in grade of thrombocytopenia
Description
The percentage of platelet transfusion-independent patients at baseline with improvement in grade of thrombocytopenia at week 24
Time Frame
Baseline to 24 weeks
Title
The percentage of transfusion-dependent patients achieving transfusion independence and achieving 50% reduction in transfusion rate
Description
The percentage of transfusion-dependent patients at baseline achieving transfusion independence and achieving 50% reduction in transfusion rate at week 24
Time Frame
Baseline to 24 weeks
Title
Hemaglobin A1c
Description
Changes in hemoglobin A1c
Time Frame
Baseline to Week 24
Title
mutated allelic burden, gene expression, and pharmacodynamic (PD) biomarkers
Description
Changes in mutated allelic burden, gene expression, and pharmacodynamic (PD) biomarkers
Time Frame
Baseline to up to 24 Weeks
Title
The proportion of patients who experience a major adverse cardiac event (MACE)
Description
MACE is a composite endpoint that is considered to occur if any of the following TEAEs occur: cardiovascular death, defined as death due to acute myocardial infarction, sudden cardiac death, death due to heart failure, death due to stroke, death due to cardiovascular procedures, death due to cardiovascular hemorrhage, or death due to peripheral artery disease non-fatal myocardial infarction non-fatal stroke of any classification, including reversible focal neurological defects with imaging evidence of a new cerebral lesion consistent with ischemia or hemorrhage
Time Frame
Baseline to up to 24 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Diagnosis and Inclusion Criteria PMF (including pre-fibrotic MF), PPV-MF, or PET-MF (Tefferi and Vandiman 2008) Average platelet count of <50,000/µL at Screening (Day -35 to Day -3) based on two measurements taken on different days; both measurements must be <50,000/µL DIPSS 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 If the patient has received prior JAK2 inhibitor treatment, this treatment must meet at least one of the following criteria: Prior treatment with any JAK2 inhibitor, irrespective of dose, with a duration of 90 days or less. 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 during that interval. Prior treatment with ruxolitinib, at no more than 10 mg total daily dose on any day, with a duration of 270 days or less. The 270-day period starts on the date of first ruxolitinib administration and continues for 270 calendar days, regardless of whether therapy is administered continuously or intermittently during that interval.The patient may not have received >10 mg of ruxolitinib on any day during that interval Age ≥18 years Eastern Cooperative Oncology Group performance status 0 to 2 Peripheral blast count of <10% throughout the Screening period and at baseline Absolute neutrophil count of ≥500/µL Left ventricular cardiac ejection fraction of ≥50% by echocardiogram or multigated acquisition (MUGA) 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 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 Exclusion Criteria Life expectancy <6 months Completed allogeneic stem cell transplant (allo-SCT) or are eligible for and willing to complete other approved available therapy including allo-SCT 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 Any prior treatment with more than one JAK2 inhibitor Treatment with an experimental therapy within 28 days prior to treatment Day 1 Systemic treatment with a strong CYP3A4 inhibitor or a strong cytochrome P450 (CYP450) 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 (e.g., 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), anti-vascular endothelial growth factor (anti-vascular endothelial growth factor [anti-VEGF]) agents, and daily use of cyclooxygenase-1 (COX-1) inhibiting nonsteroidal anti- inflammatory drugs (NSAIDs) within 14 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 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. Any history of CTCAE grade ≥2 cardiac dysrhythmias within 6 months prior to treatment Day 1. Patients with non-QTc 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. QT corrected by the Fridericia method (QTcF) prolongation >450 ms or other factors that increase the risk for QT interval prolongation (e.g., hypokalemia [defined as serum potassium <3.0 mEq/L that is persistent and refractory to correction], or history of long QT interval syndrome New York Heart Association Class II, III, or IV congestive heart failure Any active gastrointestinal or metabolic condition that could interfere with absorption of oral medication Active or uncontrolled inflammatory or chronic functional bowel disorder such as Crohn's Disease, inflammatory bowel disease, chronic diarrhea, or chronic constipation 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. 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 Known seropositivity for human immunodeficiency virus Known active hepatitis A, B, or C virus infection Women who are pregnant or lactating Concurrent enrollment in another interventional trial Severe thrombocytopenia due to vitamin B12 deficiency, folate deficiency, or viral infection in the opinion of the investigator 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simran Bedi Singh
Phone
206-272-4454
Email
ssingh@ctibiopharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
John Volpone
Phone
1-206-272-4652
Email
jvolpone@ctibiopharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simran Bedi Singh
Organizational Affiliation
CTI BioPharma
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham, (UAB) Hospital, Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Mayo Clinic Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
USC Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Completed
Facility Name
UCLA David Geffen School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Completed
Facility Name
Rocky Mountain Cancer Centers (US Oncology/McKesson)
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80303
Country
United States
Individual Site Status
Completed
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Completed
Facility Name
Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Completed
Facility Name
George Washington University-Medical Faculty Associates
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Individual Site Status
Completed
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Individual Site Status
Completed
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Completed
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Completed
Facility Name
The University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Completed
Facility Name
University of Kansas Cancer Center and Medical Pavilion
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Completed
Facility Name
Saint Agnes Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Completed
Facility Name
American Oncology Partners of Maryland, PA
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Individual Site Status
Completed
Facility Name
Regional Cancer Care Associates LLC - CCBD Division
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Individual Site Status
Withdrawn
Facility Name
Maryland Oncology Hematology, PA- Columbia
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Individual Site Status
Completed
Facility Name
Dana Farber Cancer Institute, Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Withdrawn
Facility Name
Michigan Medicine Hematology Clinic-Rogel Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Completed
Facility Name
Cancer and Hematology Centers of Western Michigan
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Individual Site Status
Completed
Facility Name
Washington University School of Medicine-Siteman Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Completed
Facility Name
Comprehensive Cancer Centers of Nevada- Twain Office
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Memorial Sloan-Kettering Cancer Center- Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Individual Site Status
Completed
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Memorial Sloan -Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Completed
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Completed
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
UPMC Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Completed
Facility Name
The Sarah Cannon Research Institute-Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Completed
Facility Name
Mays Cancer Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Completed
Facility Name
Texas Oncology- San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Completed
Facility Name
University of Utah - Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Completed
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Completed
Facility Name
Westmead Hospital
City
Sydney
State/Province
New South Wales
Country
Australia
Individual Site Status
Recruiting
Facility Name
Alfred Hospital, Malignant Hematology and Stem Cell Transplantation Service
City
Melbourne
State/Province
Victoria
Country
Australia
Individual Site Status
Recruiting
Facility Name
The Perth Blood Institute
City
Perth
State/Province
Western Australia
Country
Australia
Individual Site Status
Recruiting
Facility Name
Republican Research Center for Radiation Medicine and Human Ecology
City
Gomel
Country
Belarus
Individual Site Status
Recruiting
Facility Name
Grodno University Hospital
City
Grodno
Country
Belarus
Individual Site Status
Completed
Facility Name
Minsk Scientific and Practical Center of Surgery, Transplantology and Hematology
City
Minsk
Country
Belarus
Individual Site Status
Recruiting
Facility Name
University Clinical Centre of the Republic of Srpska
City
Banja Luka
Country
Bosnia and Herzegovina
Individual Site Status
Recruiting
Facility Name
University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski"
City
Pleven
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv
City
Plovdiv
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Multiprofile Hospital for Active Treatment - Sofia, part of Military Medical Academy
City
Sofia
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Specialized Hospital for Active Treatment of Hematological Diseases
City
Sofia
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Multiprofile Hospital for Active Treatment "Sveta Marina"
City
Varna
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Tom Baker Cancer Center, Internal Medicine/Hematology
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annette Erlich
Phone
403-521-3988
Email
Annette.Erlicj@albertahealthservices.ca
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brent Howie
Phone
403-521-3988
Email
Brent.Howie@primesiteresearch.com
Facility Name
Providence Hematology - Vancouver
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2A5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Mak
Phone
604-682-2344
Ext
64987
Email
gmak1@providencehealth.bc.ca
Facility Name
Eastern Regional Health Authority
City
Saint John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esther Pope
Phone
(709) 777-2951
Facility Name
Nova Scotia Health Authority, Centre for Clinical Research
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle Bevis
Phone
902-473-4446
Email
DanielleN.Bevis@nshealth.ca
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Sankar
Phone
(416) 946-4501
Email
Stephanie.sankar@uhn.ca
Facility Name
Jewish General Hospital; Clinical Research Unit
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chadi Zakaria
Phone
514-340-8222
Email
chadi.zakaria.ccomtl@ssss.gouv.qc.ca
Facility Name
University Hospital Brno
City
Brno
Country
Czechia
Individual Site Status
Recruiting
Facility Name
University Hospital Olomouc
City
Olomouc
Country
Czechia
Individual Site Status
Recruiting
Facility Name
University Hospital Plzen
City
Pilsen
Country
Czechia
Individual Site Status
Recruiting
Facility Name
University Hospital Kralovske Vinohrady, Clinic of Internal Hematology
City
Prague
Country
Czechia
Individual Site Status
Recruiting
Facility Name
CHU Hôpital Amiens Sud
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Name
La Conception Hospital
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Nimes - Hopital Universitaire Caremeau
City
Nîmes
ZIP/Postal Code
30900
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Saint-Louis
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Hopitaux de Bordeaux - Hôpital Haut-Lévêque
City
Pessac
ZIP/Postal Code
33604
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Lyon-Sud
City
Pierre Benite
Country
France
Individual Site Status
Recruiting
Facility Name
University Hospital Center of Poitiers
City
Poitiers
Country
France
Individual Site Status
Recruiting
Facility Name
Hautepierre Hospital
City
Strasbourg
Country
France
Individual Site Status
Withdrawn
Facility Name
Centre Hospitalier de Toulouse- Hôpital Purpan
City
Toulouse
Country
France
Individual Site Status
Withdrawn
Facility Name
JSC K. Eristavi National Center For Experimental and Clinical Surgery
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Name
LTD M.Zodelava's Hematology Center, Department of Hematology
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Name
LTD National Institute of Endocrinology
City
Tbilisi
Country
Georgia
Individual Site Status
Withdrawn
Facility Name
LTD S.Khechinashvili University Hospital
City
Tbilisi
Country
Georgia
Individual Site Status
Completed
Facility Name
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LTD
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Name
University Hospital Cologne, Department of Internal Medicine I,
City
Cologne
Country
Germany
Individual Site Status
Withdrawn
Facility Name
University Hospital Halle (Saale), Department of Internal Medicine IV - Hematology and Oncology
City
Halle
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Johannes Wesling Hospital Minden, Department of Oncology and Hematology
City
Minden
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Hospital rechts der Isar, Department of Internal Medicine III, Hematology and Oncology
City
Munich
Country
Germany
Individual Site Status
Withdrawn
Facility Name
University Hospital Ulm, Center for Internal Medicine,
City
Ulm
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Semmelweis University SE ÁOK I. sz. Belgyógyászati Klinika
City
Budapest
Country
Hungary
Individual Site Status
Recruiting
Facility Name
University of Debrecen Clinical Center (Debreceni Egyetem Klinikai Központ)
City
Debrecen
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Somogy Megyei Kaposi Mór Oktató Kórház
City
Kaposvár
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Bacs-Kiskun County Hospital, 2nd Department of Internal Medicine
City
Kecskemét
Country
Hungary
Individual Site Status
Withdrawn
Facility Name
Szabolcs-Szatmar-Bereg County Hospitals and University Teaching Hospital, Department of Hematology
City
Nyíregyháza
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Fejer County St. Gyorgy University Teaching Hospital, Department of Internal Medicine I
City
Székesfehérvár
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Lady Davis Carmel Medical Center, Department of Hematology,
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Name
Hadassah Medical Center, Department of Hematology,
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Name
Meir Medical Center, Hematology Institute and Blood Bank
City
Kfar Saba
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rabin Medical Center, Clinic for Myeloproliferative Disorders
City
Petah-Tikva
Country
Israel
Individual Site Status
Recruiting
Facility Name
The Tel Aviv Sourasky Medical Center, Department of Internal Medicine
City
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Name
Cancer Institute "Giovanni Paolo II", IRCCS
City
Bari
Country
Italy
Individual Site Status
Recruiting
Facility Name
Polyclinic S. Orsola-Malpighi
City
Bologna
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASST Spedali Civili Brescia, Hematology Unit
City
Brescia
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero-Universitaria Careggi
City
Florence
Country
Italy
Individual Site Status
Recruiting
Facility Name
Scientific Institute of Romagna for the Study and Treatment of Cancer (IRST), IRCCS
City
Forlì
Country
Italy
Individual Site Status
Recruiting
Facility Name
Maggiore Polyclinic Hospital, Fondazione IRCCS Ca' Granda
City
Milan
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASST Monza - Ospedale San Gerardo
City
Monza
Country
Italy
Individual Site Status
Recruiting
Facility Name
United Hospitals Villa Sofia Cervello
City
Palermo
Country
Italy
Individual Site Status
Recruiting
Facility Name
Polyclinic San Matteo, IRCCS
City
Pavia
Country
Italy
Individual Site Status
Recruiting
Facility Name
Hospital "Infermi" of Rimini
City
Rimini
Country
Italy
Individual Site Status
Completed
Facility Name
University Polyclinic Foundation "Agostino Gemelli"
City
Rome
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASST Sette Laghi Hospital
City
Varese
Country
Italy
Individual Site Status
Recruiting
Facility Name
Pusan National University Hospital
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Kyungpook National University Hospital
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
3722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea, St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
University Clinical Center in Gdansk
City
Gdańsk
Country
Poland
Individual Site Status
Recruiting
Facility Name
Andrzej Mielecki Independent Public Clinical Hospital of Medical University of Silesia in Katowice, Department of Hematology and Bone Marrow Transplantation
City
Katowice
Country
Poland
Individual Site Status
Recruiting
Facility Name
Pratia Oncology Katowice
City
Katowice
Country
Poland
Individual Site Status
Recruiting
Facility Name
University Hospital in Krakow
City
Kraków
Country
Poland
Individual Site Status
Recruiting
Facility Name
Jedrzej Sniadecki Specialist Hospital in Nowy Sacz, Department of Hematology
City
Nowy Sącz
Country
Poland
Individual Site Status
Recruiting
Facility Name
Frederic Chopin Provincial Teaching Hospital No. 1 in Rzeszow, Department of Hematology,
City
Rzeszów
Country
Poland
Individual Site Status
Recruiting
Facility Name
Nasz Lekarz Medical Outpatient Clinics Slawomir Jeka
City
Toruń
Country
Poland
Individual Site Status
Recruiting
Facility Name
Institute of Hematology and Transfusion Medicine, Teaching Department of Hematology
City
Warsaw
Country
Poland
Individual Site Status
Recruiting
Facility Name
Jan Mikulicz Radecki University Hospital in Wroclaw, Department and Clinic of Hematology, Blood Neoplasms and Bone Marrow Transplantation
City
Wrocław
Country
Poland
Individual Site Status
Recruiting
Facility Name
Nicolaus Copernicus Provincial Multispecialty Oncology and Traumatology Center in Lodz
City
Łódź
Country
Poland
Individual Site Status
Recruiting
Facility Name
Onco Card Srl
City
Braşov
Country
Romania
Individual Site Status
Recruiting
Facility Name
Coltea Clinical Hospital
City
Bucharest
Country
Romania
Individual Site Status
Recruiting
Facility Name
Fundeni Clinical Institute
City
Bucharest
Country
Romania
Individual Site Status
Recruiting
Facility Name
Prof. Dr. Ion Chiricuta" Institute of Oncology
City
Cluj-Napoca
Country
Romania
Individual Site Status
Recruiting
Facility Name
City Clinical Hospital #40
City
Moscow
Country
Russian Federation
Individual Site Status
Completed
Facility Name
City Clinical Hospital n.a. V.V. Veresaev of the Moscow City Health
City
Moscow
Country
Russian Federation
Individual Site Status
Completed
Facility Name
S.P. Botkin City Clinical Hospital
City
Moscow
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Clinic UZI 4D, LLC
City
Pyatigorsk
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Research Institute of Hematology and Transfusiology
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
S.M. Kirov Military Medical Academy, Department and Clinic for Intermediate-Level Training in Internal Medicine, Hematology Division
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
V.A. Almazov North-West Federal Medical Research Center, Institute of Oncology and Hematology, Scientific Department of Clinical Oncology
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
V.D. Seredavin Samara Regional Clinical Hospital, Department of Hematology
City
Samara
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Bashkiria State Medical University, Department of Internal Medicine
City
Ufa
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Volgograd Regional Clinical Oncology Center
City
Volgograd
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Clinical Center of Serbia, Clinic of Hematology
City
Belgrade
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Clinical Center of Vojvodina, Clinic of Hematology
City
Novi Sad
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Hospital del Mar
City
Barcelona,
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Name
Morales Meseguer University General Hospital, Department of Hematology and Hemotherapy
City
Murcia
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clínica Universidad de Navarra
City
Pamplona
Country
Spain
Individual Site Status
Withdrawn
Facility Name
University Clinical Hospital of Salamanca, Department of Hematology
City
Salamanca
Country
Spain
Individual Site Status
Recruiting
Facility Name
University Clinical Hospital of Valencia, Department of Hematology and Medical Oncology
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Name
Cherkasy Regional Oncology Dispensary of Cherkasy Oblast Council, Regional Treatment and Diagnostic Hematology Center, Department of Hematology
City
Cherkasy
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
City Clinical Hospital #4" under Dnipro City Council
City
Dnipro
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Regional Clinical Hospital, Department of Hematology,
City
Ivano-Frankivs'k
Country
Ukraine
Individual Site Status
Withdrawn
Facility Name
Communal Non-profit enterprise "Regional Center of Oncology", Department of Hematology
City
Kharkiv
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Kyiv City Clinical Hospital #9, Hematology Department #1
City
Kyiv
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Kyiv Regional Oncology Center, Department of Hematology,
City
Kyiv
Country
Ukraine
Individual Site Status
Completed
Facility Name
Limited Liability Company "City Doctor"
City
Kyiv
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Institute of Blood Pathology and Transfusion Medicine, Department of Hematology
City
Lviv
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Poltava M.V. Sklifosovskyi Regional Clinical Hospital under Poltava Regional Council, Department of Hematology
City
Poltava
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Royal Hallamshire Hospital, Department of Hematology
City
Sheffield
State/Province
South Yorkshire
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G12 0ZD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Gloucestershire Royal Hospital
City
Gloucester
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Barts Health NHS Trust - The Royal London Hospital
City
London
ZIP/Postal Code
E1 2ES
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Imperial College Healthcare NHS Trust - Hammersmith Hospital
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Christie NHS Foundation Trust
City
Manchester
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
Oxford University Hospitals NHS Trust - Churchill Hospital
City
Oxford
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33232476
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.
Results Reference
derived

Learn more about this trial

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

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