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

• ClinicalTrials.gov Identifier: NCT03165734
• Recruitment Status: Recruiting
• First Posted: May 24, 2017
• Last Update Posted: May 20, 2024
• Sponsor: CTI BioPharma
• Collaborator: PSI CRO
• Information provided by (Responsible Party): CTI BioPharma

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

Condition or disease	Intervention/treatment	Phase
Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis	Drug: Pacritinib; Drug: Physician's Choice medications	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 399 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: June 26, 2017
• Estimated Primary Completion Date: June 30, 2025
• Estimated Study Completion Date: December 31, 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: Pacritinib 200 mg BID; To receive pacritinib 200 mg twice daily (BID) orally, at the same time of day, with or without food	Drug: Pacritinib; Oral administration. Supplied in capsules containing 100 mg (as the free base) in red cap/gray body size 0 opaque hard gelatin capsules. The inactive ingredients are microcrystalline cellulose, magnesium stearate, and polyethylene glycol 8000. Each capsule contains 146 mg of pacritinib citrate, which is equivalent to 100 mg pacritinib free base
Active Comparator: Physician's Choice (P/C) therapy; The Physician's Choice (P/C) therapy (limited to single drugs from the following list: corticosteroids, hydroxyurea, danazol, or low-dose ruxolitinib). The proposed P/C regimen for a patient must be selected prior to randomization.	Drug: Physician's Choice medications; Physician's Choice medications will be selected and administered according to the investigator's judgement. Investigators can select individual P/C agents but cannot combine agents or give them sequentially.; Other Names: corticosteroids; hydroxyurea; danazol; low-dose ruxolitinib

Outcome Measures

Primary Outcome Measures :

1. Spleen volume [ Time Frame: From baseline at 24 weeks ]
   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
2. Total Symptom Score (TSS) (excluding tiredness) [ Time Frame: From baseline at Week 24 ]
   To compare the efficacy of pacritinib compared to P/C therapy, as assessed by the proportion of patients achieving a ≥50% reduction in Total Symptom Score (TSS). The TSS is the sum of the individual symptom scores for tiredness, early satiety, abdominal discomfort, night sweats, pruritus, bone pain, and pain under ribs on the left side. Symptoms are ranked 0 (absent) to 10 (worst imaginable)

Secondary Outcome Measures :

1. Overall Survival (OS) [ Time Frame: until 2.5 years after the date of randomization ]
   To compare the overall survival (OS) of patients treated with pacritinib versus those treated with P/C
2. Patient Global Impression of Change (PGIC) assessed at Week 24 [ Time Frame: End of Week 12 to 2 years following Week 24 visit ]
   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
3. To compare the safety of pacritinib versus P/C therapy [ Time Frame: Randomization through 30 after last treatment ]
   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.

Other Outcome Measures:

1. SVR of ≥35% [ Time Frame: Up to 24 Weeks ]
   Time to achievement of SVR of ≥35%
2. Best response in SVR [ Time Frame: At 24 Weeks ]
   Best response in SVR by MRI or CT scan
3. >25% SVR [ Time Frame: From baseline and at Week 24 ]
   Proportion of patients achieving >25% SVR
4. Red blood cell (RBC) [ Time Frame: Baseline to End of Treatment ]
   Achievement of red blood cell (RBC) transfusion independence at Weeks 12 and 24
5. hemoglobin level [ Time Frame: Weeks 12 and 24 ]
   Improvement in hemoglobin level without transfusion at Weeks 12 and 24
6. platelet count [ Time Frame: Weeks 12 and 24 ]
   Improvement in platelet count at Weeks 12 and 24
7. platelet transfusions [ Time Frame: Weeks 12 and 24 ]
   Frequency of platelet transfusions at Weeks 12 and 24
8. PROMIS [ Time Frame: Baseline to Week 24 ]
   Improvement in fatigue as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) v.1.0 - Fatigue from Baseline through Week 24
9. Leukemia-free survival (LFS) [ Time Frame: Baseline to Week 24 ]
   Leukemia-free survival (LFS) of patients treated with pacritinib versus P/C therapy
10. The percentage of red blood cell transfusion-independent patients achieving a 1 g/dL and a 2 g/dL increase in hemoglobin [ Time Frame: Baseline to 24 weeks ]
    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
11. The percentage of platelet transfusion-independent patients with improvement in grade of thrombocytopenia [ Time Frame: Baseline to 24 weeks ]
    The percentage of platelet transfusion-independent patients at baseline with improvement in grade of thrombocytopenia at week 24
12. The percentage of transfusion-dependent patients achieving transfusion independence and achieving 50% reduction in transfusion rate [ Time Frame: Baseline to 24 weeks ]
    The percentage of transfusion-dependent patients at baseline achieving transfusion independence and achieving 50% reduction in transfusion rate at week 24
13. Hemaglobin A1c [ Time Frame: Baseline to Week 24 ]
    Changes in hemoglobin A1c
14. mutated allelic burden, gene expression, and pharmacodynamic (PD) biomarkers [ Time Frame: Baseline to up to 24 Weeks ]
    Changes in mutated allelic burden, gene expression, and pharmacodynamic (PD) biomarkers
15. The proportion of patients who experience a major adverse cardiac event (MACE) [ Time Frame: Baseline to up to 24 Weeks ]

    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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 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 within 28 days prior to treatment Day 1
11. Systemic treatment with a strong cytochrome P450 3A4 inhibitor or a strong cytochrome P450 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), anti-vascular endothelial growth factor (anti-VEGF) agents, and daily use of cyclooxygenase-1 (COX-1) inhibiting non-steroidal anti-inflammatory drugs (NSAIDs) within 14 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

Contacts and Locations

Contacts

Contact: Simran Bedi Singh; 206-272-4454; simran.singh@sobi.com

Locations

United States, Alabama

University of Alabama at Birmingham, (UAB) Hospital, Comprehensive Cancer Center; Active, not recruiting

Birmingham, Alabama, United States, 35294

United States, Arizona

Mayo Clinic Hospital; Completed

Phoenix, Arizona, United States, 85054

United States, California

City of Hope; Active, not recruiting

Duarte, California, United States, 91010

USC Norris Comprehensive Cancer Center; Completed

Los Angeles, California, United States, 90033

UCLA David Geffen School of Medicine; Completed

Los Angeles, California, United States, 90095

United States, Colorado

University of Colorado Cancer Center; Completed

Aurora, Colorado, United States, 80045

Rocky Mountain Cancer Centers (US Oncology/McKesson); Completed

Boulder, Colorado, United States, 80303

United States, Connecticut

Yale School of Medicine; Completed

New Haven, Connecticut, United States, 06510

United States, District of Columbia

Georgetown University Hospital; Completed

Washington, District of Columbia, United States, 20007

George Washington University-Medical Faculty Associates; Completed

Washington, District of Columbia, United States, 20037

United States, Florida

Cleveland Clinic Florida; Completed

Weston, Florida, United States, 33331

United States, Illinois

Northwestern Memorial Hospital; Completed

Chicago, Illinois, United States, 60611

Rush University Medical Center; Completed

Chicago, Illinois, United States, 60612

The University of Chicago Medical Center; Completed

Chicago, Illinois, United States, 60637

United States, Kansas

University of Kansas Cancer Center and Medical Pavilion; Completed

Westwood, Kansas, United States, 66205

United States, Louisiana

Ochsner Medical Center; Completed

New Orleans, Louisiana, United States, 70121

United States, Maryland

Saint Agnes Hospital; Active, not recruiting

Baltimore, Maryland, United States, 21229

Johns Hopkins University; Completed

Baltimore, Maryland, United States, 21287

American Oncology Partners of Maryland, PA; Completed

Bethesda, Maryland, United States, 20817

Regional Cancer Care Associates LLC - CCBD Division; Withdrawn

Bethesda, Maryland, United States, 20817

Maryland Oncology Hematology, PA- Columbia; Completed

Columbia, Maryland, United States, 21044

United States, Massachusetts

Dana Farber Cancer Institute, Massachusetts General Hospital; Withdrawn

Boston, Massachusetts, United States, 02215

United States, Michigan

Michigan Medicine Hematology Clinic-Rogel Cancer Center; Completed

Ann Arbor, Michigan, United States, 48109

Cancer and Hematology Centers of Western Michigan; Completed

Grand Rapids, Michigan, United States, 49546

United States, Missouri

Washington University School of Medicine-Siteman Cancer Center; Completed

Saint Louis, Missouri, United States, 63110

United States, Nevada

Comprehensive Cancer Centers of Nevada- Twain Office; Completed

Las Vegas, Nevada, United States, 89169

United States, New Jersey

Hackensack University Medical Center; Active, not recruiting

Hackensack, New Jersey, United States, 07601

United States, New York

Memorial Sloan-Kettering Cancer Center- Commack; Active, not recruiting

Commack, New York, United States, 11725

Columbia University Medical Center; Completed

New York, New York, United States, 10017

Weill Cornell Medical College; Active, not recruiting

New York, New York, United States, 10021

Icahn School of Medicine at Mount Sinai; Active, not recruiting

New York, New York, United States, 10029

Memorial Sloan -Kettering Cancer Center; Completed

New York, New York, United States, 10065

University of Rochester; Completed

Rochester, New York, United States, 14642

United States, North Carolina

Duke University Hospital; Completed

Durham, North Carolina, United States, 27710

United States, Ohio

Cleveland Clinic; Completed

Cleveland, Ohio, United States, 44106

Ohio State University Comprehensive Cancer Center; Active, not recruiting

Columbus, Ohio, United States, 43210

United States, Oregon

Oregon Health and Science University; Active, not recruiting

Portland, Oregon, United States, 97239-3098

United States, Pennsylvania

UPMC Hillman Cancer Center; Completed

Pittsburgh, Pennsylvania, United States, 15232

United States, Tennessee

The Sarah Cannon Research Institute-Tennessee Oncology; Completed

Nashville, Tennessee, United States, 37203

United States, Texas

The University of Texas MD Anderson Cancer Center; Completed

Houston, Texas, United States, 77030

Mays Cancer Center; Completed

San Antonio, Texas, United States, 78229

Texas Oncology- San Antonio; Completed

San Antonio, Texas, United States, 78240

United States, Utah

University of Utah - Huntsman Cancer Institute; Completed

Salt Lake City, Utah, United States, 84112

United States, Washington

Fred Hutchinson Cancer Research Center; Completed

Seattle, Washington, United States, 98109

Australia, New South Wales

Westmead Hospital; Recruiting

Sydney, New South Wales, Australia

Australia, Victoria

Alfred Hospital, Malignant Hematology and Stem Cell Transplantation Service; Recruiting

Melbourne, Victoria, Australia

Australia, Western Australia

The Perth Blood Institute; Recruiting

Perth, Western Australia, Australia

Belarus

Republican Research Center for Radiation Medicine and Human Ecology; Recruiting

Gomel, Belarus

Grodno University Hospital; Completed

Grodno, Belarus

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

Minsk, Belarus

Bosnia and Herzegovina

University Clinical Centre of the Republic of Srpska; Recruiting

Banja Luka, Bosnia and Herzegovina

University Clinical Center of Sarajevo; Recruiting

Sarajevo, Bosnia and Herzegovina

Bulgaria

University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski"; Recruiting

Pleven, Bulgaria

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

Plovdiv, Bulgaria

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

Sofia, Bulgaria

Specialized Hospital for Active Treatment of Hematological Diseases; Recruiting

Sofia, Bulgaria

Multiprofile Hospital for Active Treatment "Sveta Marina"; Recruiting

Varna, Bulgaria

Canada, Alberta

Tom Baker Cancer Center, Internal Medicine/Hematology; Recruiting

Calgary, Alberta, Canada

University of Alberta; Recruiting

Edmonton, Alberta, Canada

Canada, British Columbia

Providence Hematology - Vancouver; Recruiting

Vancouver, British Columbia, Canada

Canada, Newfoundland and Labrador

Eastern Regional Health Authority; Recruiting

Saint John's, Newfoundland and Labrador, Canada

Canada, Nova Scotia

Nova Scotia Health Authority, Centre for Clinical Research; Recruiting

Halifax, Nova Scotia, Canada

Canada, Ontario

Princess Margaret Cancer Centre; Recruiting

Toronto, Ontario, Canada

Canada, Quebec

Jewish General Hospital; Clinical Research Unit; Recruiting

Montreal, Quebec, Canada

Czechia

University Hospital Brno; Recruiting

Brno, Czechia

University Hospital Olomouc; Recruiting

Olomouc, Czechia

University Hospital Plzen; Recruiting

Pilsen, Czechia

University Hospital Kralovske Vinohrady, Clinic of Internal Hematology; Recruiting

Prague, Czechia

France

CHU Hôpital Amiens Sud; Recruiting

Amiens, France, 80054

La Conception Hospital; Recruiting

Marseille, France

CHU de Nimes - Hopital Universitaire Caremeau; Recruiting

Nîmes, France, 30900

Hôpital Saint-Louis; Recruiting

Paris, France

CHU Hopitaux de Bordeaux - Hôpital Haut-Lévêque; Recruiting

Pessac, France, 33604

Centre Hospitalier Lyon-Sud; Recruiting

Pierre Benite, France

University Hospital Center of Poitiers; Recruiting

Poitiers, France

Hautepierre Hospital; Withdrawn

Strasbourg, France

Centre Hospitalier de Toulouse- Hôpital Purpan; Withdrawn

Toulouse, France

Georgia

JSC K. Eristavi National Center For Experimental and Clinical Surgery; Recruiting

Tbilisi, Georgia

LTD M.Zodelava's Hematology Center, Department of Hematology; Recruiting

Tbilisi, Georgia

LTD National Institute of Endocrinology; Withdrawn

Tbilisi, Georgia

LTD S.Khechinashvili University Hospital; Completed

Tbilisi, Georgia

Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LTD; Recruiting

Tbilisi, Georgia

Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC; Recruiting

Tbilisi, Georgia

Germany

University Hospital Cologne, Department of Internal Medicine I,; Withdrawn

Cologne, Germany

University Hospital Halle (Saale), Department of Internal Medicine IV - Hematology and Oncology; Withdrawn

Halle, Germany

Johannes Wesling Hospital Minden, Department of Oncology and Hematology; Withdrawn

Minden, Germany

Hospital rechts der Isar, Department of Internal Medicine III, Hematology and Oncology; Withdrawn

Munich, Germany

University Hospital Ulm, Center for Internal Medicine,; Withdrawn

Ulm, Germany

Hungary

Semmelweis University SE ÁOK I. sz. Belgyógyászati Klinika; Recruiting

Budapest, Hungary

University of Debrecen Clinical Center (Debreceni Egyetem Klinikai Központ); Recruiting

Debrecen, Hungary

Somogy Megyei Kaposi Mór Oktató Kórház; Recruiting

Kaposvár, Hungary

Bacs-Kiskun County Hospital, 2nd Department of Internal Medicine; Withdrawn

Kecskemét, Hungary

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

Nyíregyháza, Hungary

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

Székesfehérvár, Hungary

India

Sahyadri Super Speciality Hospital; Recruiting

Pune, Maharashtra, India

St. John's Medical College Hospital; Recruiting

Bengaluru, India

Israel

Lady Davis Carmel Medical Center, Department of Hematology,; Recruiting

Haifa, Israel

Hadassah Medical Center, Department of Hematology,; Recruiting

Jerusalem, Israel

Meir Medical Center, Hematology Institute and Blood Bank; Recruiting

Kfar Saba, Israel

Rabin Medical Center, Clinic for Myeloproliferative Disorders; Recruiting

Petah-Tikva, Israel

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

Tel Aviv, Israel

Italy

Cancer Institute "Giovanni Paolo II", IRCCS; Recruiting

Bari, Italy

Polyclinic S. Orsola-Malpighi; Recruiting

Bologna, Italy

ASST Spedali Civili Brescia, Hematology Unit; Recruiting

Brescia, Italy

Azienda Ospedaliero-Universitaria Careggi; Recruiting

Florence, Italy

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

Forlì, Italy

Maggiore Polyclinic Hospital, Fondazione IRCCS Ca' Granda; Recruiting

Milan, Italy

ASST Monza - Ospedale San Gerardo; Recruiting

Monza, Italy

University Hospital "Federico II"; Recruiting

Naples, Italy

University Hospital "Maggiore della Carita" of Novara; Recruiting

Novara, Italy

United Hospitals Villa Sofia Cervello; Recruiting

Palermo, Italy

Polyclinic San Matteo, IRCCS; Recruiting

Pavia, Italy

Hospital "Infermi" of Rimini; Completed

Rimini, Italy

Umberto I Polyclinic of Rome; Recruiting

Rome, Italy

University Polyclinic Foundation "Agostino Gemelli"; Recruiting

Rome, Italy

City of Health and Science of Turin; Recruiting

Turin, Italy

Santa Maria della Misericordia University Hospital of Udine; Recruiting

Udine, Italy

ASST Sette Laghi Hospital; Recruiting

Varese, Italy

Korea, Republic of

Pusan National University Hospital; Recruiting

Busan, Korea, Republic of

Kyungpook National University Hospital; Recruiting

Daegu, Korea, Republic of

Severance Hospital; Recruiting

Seoul, Korea, Republic of, 3722

Samsung Medical Center; Recruiting

Seoul, Korea, Republic of

Seoul National University Hospital; Recruiting

Seoul, Korea, Republic of

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

Seoul, Korea, Republic of

Poland

University Teaching Hospital in Bialystok; Recruiting

Białystok, Poland

University Clinical Center in Gdansk; Recruiting

Gdańsk, Poland

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

Katowice, Poland

Pratia Oncology Katowice; Recruiting

Katowice, Poland

University Hospital in Krakow; Recruiting

Kraków, Poland

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

Lublin, Poland

Jedrzej Sniadecki Specialist Hospital in Nowy Sacz, Department of Hematology; Recruiting

Nowy Sącz, Poland

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

Rzeszów, Poland

Nasz Lekarz Medical Outpatient Clinics Slawomir Jeka; Recruiting

Toruń, Poland

Institute of Hematology and Transfusion Medicine, Teaching Department of Hematology; Recruiting

Warsaw, Poland

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

Wrocław, Poland

Nicolaus Copernicus Provincial Multispecialty Oncology and Traumatology Center in Lodz; Recruiting

Łódź, Poland

Romania

Onco Card Srl; Recruiting

Braşov, Romania

Coltea Clinical Hospital; Recruiting

Bucharest, Romania

Fundeni Clinical Institute; Recruiting

Bucharest, Romania

Prof. Dr. Ion Chiricuta" Institute of Oncology; Recruiting

Cluj-Napoca, Romania

Russian Federation

City Clinical Hospital #40; Completed

Moscow, Russian Federation

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

Moscow, Russian Federation

S.P. Botkin City Clinical Hospital; Active, not recruiting

Moscow, Russian Federation

Clinic UZI 4D, LLC; Active, not recruiting

Pyatigorsk, Russian Federation

Research Institute of Hematology and Transfusiology; Active, not recruiting

Saint Petersburg, Russian Federation

S.M. Kirov Military Medical Academy, Department and Clinic for Intermediate-Level Training in Internal Medicine, Hematology Division; Active, not recruiting

Saint Petersburg, Russian Federation

V.A. Almazov North-West Federal Medical Research Center, Institute of Oncology and Hematology, Scientific Department of Clinical Oncology; Active, not recruiting

Saint Petersburg, Russian Federation

V.D. Seredavin Samara Regional Clinical Hospital, Department of Hematology; Withdrawn

Samara, Russian Federation

Bashkiria State Medical University, Department of Internal Medicine; Completed

Ufa, Russian Federation

Volgograd Regional Clinical Oncology Center; Completed

Volgograd, Russian Federation

Serbia

Clinical Center of Serbia, Clinic of Hematology; Recruiting

Belgrade, Serbia

Clinical Center of Vojvodina, Clinic of Hematology; Recruiting

Novi Sad, Serbia

Spain

Hospital del Mar; Recruiting

Barcelona,, Spain

Hospital Clínic de Barcelona; Recruiting

Barcelona, Spain

University Hospital Vall d'Hebron; Recruiting

Barcelona, Spain

Hospital Universitario Ramón y Cajal; Recruiting

Madrid, Spain

University Hospital 12 de Octubre, Department of Hematology; Recruiting

Madrid, Spain

Morales Meseguer University General Hospital, Department of Hematology and Hemotherapy; Recruiting

Murcia, Spain

Clínica Universidad de Navarra; Withdrawn

Pamplona, Spain

University Clinical Hospital of Salamanca, Department of Hematology; Recruiting

Salamanca, Spain

University Hospital Virgen del Rocio (HUVR); Recruiting

Seville, Spain

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

Valencia, Spain

Ukraine

Cherkasy Regional Oncology Dispensary of Cherkasy Oblast Council, Regional Treatment and Diagnostic Hematology Center, Department of Hematology; Active, not recruiting

Cherkasy, Ukraine

City Clinical Hospital #4" under Dnipro City Council; Active, not recruiting

Dnipro, Ukraine

Regional Clinical Hospital, Department of Hematology,; Withdrawn

Ivano-Frankivs'k, Ukraine

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

Kharkiv, Ukraine

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

Kyiv, Ukraine

Kyiv Regional Oncology Center, Department of Hematology,; Completed

Kyiv, Ukraine

Limited Liability Company "City Doctor"; Active, not recruiting

Kyiv, Ukraine

Institute of Blood Pathology and Transfusion Medicine, Department of Hematology; Active, not recruiting

Lviv, Ukraine

Poltava M.V. Sklifosovskyi Regional Clinical Hospital under Poltava Regional Council, Department of Hematology; Active, not recruiting

Poltava, Ukraine

United Kingdom

Royal Hallamshire Hospital, Department of Hematology; Recruiting

Sheffield, South Yorkshire, United Kingdom

Beatson West of Scotland Cancer Centre; Recruiting

Glasgow, United Kingdom, G12 0ZD

Gloucestershire Royal Hospital; Recruiting

Gloucester, United Kingdom

Barts Health NHS Trust - The Royal London Hospital; Recruiting

London, United Kingdom, E1 2ES

Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital; Recruiting

London, United Kingdom

Imperial College Healthcare NHS Trust - Hammersmith Hospital; Recruiting

London, United Kingdom

The Christie NHS Foundation Trust; Withdrawn

Manchester, United Kingdom

Oxford University Hospitals NHS Trust - Churchill Hospital; Recruiting

Oxford, United Kingdom

Sponsors and Collaborators

CTI BioPharma

PSI CRO

Investigators

• Study Director: Simran Bedi Singh; CTI BioPharma

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: CTI BioPharma
• ClinicalTrials.gov Identifier: NCT03165734
• Other Study ID Numbers: PAC203/PAC303; PAC303 ( Other Identifier: CTI BioPharma )
• First Posted: May 24, 2017
• Last Update Posted: May 20, 2024
• Last Verified: May 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by CTI BioPharma:

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

Additional relevant MeSH terms:

Polycythemia Vera; Primary Myelofibrosis; Polycythemia; Thrombocytosis; Thrombocythemia, Essential; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Neoplasms; Blood Platelet Disorders; Blood Coagulation Disorders; Hemorrhagic Disorders; Hydroxyurea; Antineoplastic Agents; Antisickling Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors