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Spots Global Cancer Trial Database for A Phase 3 Study of Pacritinib in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis

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Trial Identification

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

Official Title: A Randomized, Controlled Phase 3 Study of Pacritinib Versus Physician's Choice in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis With Severe Thrombocytopenia (Platelet Count <50,000/μL)(PACIFICA)

Study ID: NCT03165734

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of Alabama at Birmingham, (UAB) Hospital, Comprehensive Cancer Center, Birmingham, Alabama, United States

Mayo Clinic Hospital, Phoenix, Arizona, United States

City of Hope, Duarte, California, United States

USC Norris Comprehensive Cancer Center, Los Angeles, California, United States

UCLA David Geffen School of Medicine, Los Angeles, California, United States

University of Colorado Cancer Center, Aurora, Colorado, United States

Rocky Mountain Cancer Centers (US Oncology/McKesson), Boulder, Colorado, United States

Yale School of Medicine, New Haven, Connecticut, United States

Georgetown University Hospital, Washington, District of Columbia, United States

George Washington University-Medical Faculty Associates, Washington, District of Columbia, United States

Cleveland Clinic Florida, Weston, Florida, United States

Northwestern Memorial Hospital, Chicago, Illinois, United States

Rush University Medical Center, Chicago, Illinois, United States

The University of Chicago Medical Center, Chicago, Illinois, United States

University of Kansas Cancer Center and Medical Pavilion, Westwood, Kansas, United States

Ochsner Medical Center, New Orleans, Louisiana, United States

Saint Agnes Hospital, Baltimore, Maryland, United States

Johns Hopkins University, Baltimore, Maryland, United States

American Oncology Partners of Maryland, PA, Bethesda, Maryland, United States

Regional Cancer Care Associates LLC - CCBD Division, Bethesda, Maryland, United States

Maryland Oncology Hematology, PA- Columbia, Columbia, Maryland, United States

Dana Farber Cancer Institute, Massachusetts General Hospital, Boston, Massachusetts, United States

Michigan Medicine Hematology Clinic-Rogel Cancer Center, Ann Arbor, Michigan, United States

Cancer and Hematology Centers of Western Michigan, Grand Rapids, Michigan, United States

Washington University School of Medicine-Siteman Cancer Center, Saint Louis, Missouri, United States

Comprehensive Cancer Centers of Nevada- Twain Office, Las Vegas, Nevada, United States

Hackensack University Medical Center, Hackensack, New Jersey, United States

Memorial Sloan-Kettering Cancer Center- Commack, Commack, New York, United States

Columbia University Medical Center, New York, New York, United States

Weill Cornell Medical College, New York, New York, United States

Icahn School of Medicine at Mount Sinai, New York, New York, United States

Memorial Sloan -Kettering Cancer Center, New York, New York, United States

University of Rochester, Rochester, New York, United States

Duke University Hospital, Durham, North Carolina, United States

Cleveland Clinic, Cleveland, Ohio, United States

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

Oregon Health and Science University, Portland, Oregon, United States

UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

The Sarah Cannon Research Institute-Tennessee Oncology, Nashville, Tennessee, United States

The University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Mays Cancer Center, San Antonio, Texas, United States

Texas Oncology- San Antonio, San Antonio, Texas, United States

University of Utah - Huntsman Cancer Institute, Salt Lake City, Utah, United States

Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

Westmead Hospital, Sydney, New South Wales, Australia

Alfred Hospital, Malignant Hematology and Stem Cell Transplantation Service, Melbourne, Victoria, Australia

The Perth Blood Institute, Perth, Western Australia, Australia

Republican Research Center for Radiation Medicine and Human Ecology, Gomel, , Belarus

Grodno University Hospital, Grodno, , Belarus

Minsk Scientific and Practical Center of Surgery, Transplantology and Hematology, Minsk, , Belarus

University Clinical Centre of the Republic of Srpska, Banja Luka, , Bosnia and Herzegovina

University Clinical Center of Sarajevo, Sarajevo, , Bosnia and Herzegovina

University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski", Pleven, , Bulgaria

University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv, Plovdiv, , Bulgaria

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

Specialized Hospital for Active Treatment of Hematological Diseases, Sofia, , Bulgaria

Multiprofile Hospital for Active Treatment "Sveta Marina", Varna, , Bulgaria

Tom Baker Cancer Center, Internal Medicine/Hematology, Calgary, Alberta, Canada

University of Alberta, Edmonton, Alberta, Canada

Providence Hematology - Vancouver, Vancouver, British Columbia, Canada

Eastern Regional Health Authority, Saint John's, Newfoundland and Labrador, Canada

Nova Scotia Health Authority, Centre for Clinical Research, Halifax, Nova Scotia, Canada

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

Jewish General Hospital; Clinical Research Unit, Montreal, Quebec, Canada

University Hospital Brno, Brno, , Czechia

University Hospital Olomouc, Olomouc, , Czechia

University Hospital Plzen, Pilsen, , Czechia

University Hospital Kralovske Vinohrady, Clinic of Internal Hematology, Prague, , Czechia

CHU Hôpital Amiens Sud, Amiens, , France

La Conception Hospital, Marseille, , France

CHU de Nimes - Hopital Universitaire Caremeau, Nîmes, , France

Hôpital Saint-Louis, Paris, , France

CHU Hopitaux de Bordeaux - Hôpital Haut-Lévêque, Pessac, , France

Centre Hospitalier Lyon-Sud, Pierre Benite, , France

University Hospital Center of Poitiers, Poitiers, , France

Hautepierre Hospital, Strasbourg, , France

Centre Hospitalier de Toulouse- Hôpital Purpan, Toulouse, , France

JSC K. Eristavi National Center For Experimental and Clinical Surgery, Tbilisi, , Georgia

LTD M.Zodelava's Hematology Center, Department of Hematology, Tbilisi, , Georgia

LTD National Institute of Endocrinology, Tbilisi, , Georgia

LTD S.Khechinashvili University Hospital, Tbilisi, , Georgia

Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LTD, Tbilisi, , Georgia

Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC, Tbilisi, , Georgia

University Hospital Cologne, Department of Internal Medicine I,, Cologne, , Germany

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

Johannes Wesling Hospital Minden, Department of Oncology and Hematology, Minden, , Germany

Hospital rechts der Isar, Department of Internal Medicine III, Hematology and Oncology, Munich, , Germany

University Hospital Ulm, Center for Internal Medicine,, Ulm, , Germany

Semmelweis University SE ÁOK I. sz. Belgyógyászati Klinika, Budapest, , Hungary

University of Debrecen Clinical Center (Debreceni Egyetem Klinikai Központ), Debrecen, , Hungary

Somogy Megyei Kaposi Mór Oktató Kórház, Kaposvár, , Hungary

Bacs-Kiskun County Hospital, 2nd Department of Internal Medicine, Kecskemét, , Hungary

Szabolcs-Szatmar-Bereg County Hospitals and University Teaching Hospital, Department of Hematology, Nyíregyháza, , Hungary

Fejer County St. Gyorgy University Teaching Hospital, Department of Internal Medicine I, Székesfehérvár, , Hungary

Sahyadri Super Speciality Hospital, Pune, Maharashtra, India

St. John's Medical College Hospital, Bengaluru, , India

Lady Davis Carmel Medical Center, Department of Hematology,, Haifa, , Israel

Hadassah Medical Center, Department of Hematology,, Jerusalem, , Israel

Meir Medical Center, Hematology Institute and Blood Bank, Kfar Saba, , Israel

Rabin Medical Center, Clinic for Myeloproliferative Disorders, Petah-Tikva, , Israel

The Tel Aviv Sourasky Medical Center, Department of Internal Medicine, Tel Aviv, , Israel

Cancer Institute "Giovanni Paolo II", IRCCS, Bari, , Italy

Polyclinic S. Orsola-Malpighi, Bologna, , Italy

ASST Spedali Civili Brescia, Hematology Unit, Brescia, , Italy

Azienda Ospedaliero-Universitaria Careggi, Florence, , Italy

Scientific Institute of Romagna for the Study and Treatment of Cancer (IRST), IRCCS, Forlì, , Italy

Maggiore Polyclinic Hospital, Fondazione IRCCS Ca' Granda, Milan, , Italy

ASST Monza - Ospedale San Gerardo, Monza, , Italy

University Hospital "Federico II", Naples, , Italy

University Hospital "Maggiore della Carita" of Novara, Novara, , Italy

United Hospitals Villa Sofia Cervello, Palermo, , Italy

Polyclinic San Matteo, IRCCS, Pavia, , Italy

Hospital "Infermi" of Rimini, Rimini, , Italy

Umberto I Polyclinic of Rome, Rome, , Italy

University Polyclinic Foundation "Agostino Gemelli", Rome, , Italy

City of Health and Science of Turin, Turin, , Italy

Santa Maria della Misericordia University Hospital of Udine, Udine, , Italy

ASST Sette Laghi Hospital, Varese, , Italy

Pusan National University Hospital, Busan, , Korea, Republic of

Kyungpook National University Hospital, Daegu, , Korea, Republic of

Severance Hospital, Seoul, , Korea, Republic of

Samsung Medical Center, Seoul, , Korea, Republic of

Seoul National University Hospital, Seoul, , Korea, Republic of

The Catholic University of Korea, St. Mary's Hospital, Seoul, , Korea, Republic of

University Teaching Hospital in Bialystok, Białystok, , Poland

University Clinical Center in Gdansk, Gdańsk, , Poland

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

Pratia Oncology Katowice, Katowice, , Poland

University Hospital in Krakow, Kraków, , Poland

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

Jedrzej Sniadecki Specialist Hospital in Nowy Sacz, Department of Hematology, Nowy Sącz, , Poland

Frederic Chopin Provincial Teaching Hospital No. 1 in Rzeszow, Department of Hematology,, Rzeszów, , Poland

Nasz Lekarz Medical Outpatient Clinics Slawomir Jeka, Toruń, , Poland

Institute of Hematology and Transfusion Medicine, Teaching Department of Hematology, Warsaw, , Poland

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

Nicolaus Copernicus Provincial Multispecialty Oncology and Traumatology Center in Lodz, Łódź, , Poland

Onco Card Srl, Braşov, , Romania

Coltea Clinical Hospital, Bucharest, , Romania

Fundeni Clinical Institute, Bucharest, , Romania

Prof. Dr. Ion Chiricuta" Institute of Oncology, Cluj-Napoca, , Romania

City Clinical Hospital #40, Moscow, , Russian Federation

City Clinical Hospital n.a. V.V. Veresaev of the Moscow City Health, Moscow, , Russian Federation

S.P. Botkin City Clinical Hospital, Moscow, , Russian Federation

Clinic UZI 4D, LLC, Pyatigorsk, , Russian Federation

Research Institute of Hematology and Transfusiology, Saint Petersburg, , Russian Federation

S.M. Kirov Military Medical Academy, Department and Clinic for Intermediate-Level Training in Internal Medicine, Hematology Division, Saint Petersburg, , Russian Federation

V.A. Almazov North-West Federal Medical Research Center, Institute of Oncology and Hematology, Scientific Department of Clinical Oncology, Saint Petersburg, , Russian Federation

V.D. Seredavin Samara Regional Clinical Hospital, Department of Hematology, Samara, , Russian Federation

Bashkiria State Medical University, Department of Internal Medicine, Ufa, , Russian Federation

Volgograd Regional Clinical Oncology Center, Volgograd, , Russian Federation

Clinical Center of Serbia, Clinic of Hematology, Belgrade, , Serbia

Clinical Center of Vojvodina, Clinic of Hematology, Novi Sad, , Serbia

Hospital del Mar, Barcelona,, , Spain

Hospital Clínic de Barcelona, Barcelona, , Spain

University Hospital Vall d'Hebron, Barcelona, , Spain

Hospital Universitario Ramón y Cajal, Madrid, , Spain

University Hospital 12 de Octubre, Department of Hematology, Madrid, , Spain

Morales Meseguer University General Hospital, Department of Hematology and Hemotherapy, Murcia, , Spain

Clínica Universidad de Navarra, Pamplona, , Spain

University Clinical Hospital of Salamanca, Department of Hematology, Salamanca, , Spain

University Hospital Virgen del Rocio (HUVR), Seville, , Spain

University Clinical Hospital of Valencia, Department of Hematology and Medical Oncology, Valencia, , Spain

Cherkasy Regional Oncology Dispensary of Cherkasy Oblast Council, Regional Treatment and Diagnostic Hematology Center, Department of Hematology, Cherkasy, , Ukraine

City Clinical Hospital #4" under Dnipro City Council, Dnipro, , Ukraine

Regional Clinical Hospital, Department of Hematology,, Ivano-Frankivs'k, , Ukraine

Communal Non-profit enterprise "Regional Center of Oncology", Department of Hematology, Kharkiv, , Ukraine

Kyiv City Clinical Hospital #9, Hematology Department #1, Kyiv, , Ukraine

Kyiv Regional Oncology Center, Department of Hematology,, Kyiv, , Ukraine

Limited Liability Company "City Doctor", Kyiv, , Ukraine

Institute of Blood Pathology and Transfusion Medicine, Department of Hematology, Lviv, , Ukraine

Poltava M.V. Sklifosovskyi Regional Clinical Hospital under Poltava Regional Council, Department of Hematology, Poltava, , Ukraine

Royal Hallamshire Hospital, Department of Hematology, Sheffield, South Yorkshire, United Kingdom

Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom

Gloucestershire Royal Hospital, Gloucester, , United Kingdom

Barts Health NHS Trust - The Royal London Hospital, London, , United Kingdom

Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital, London, , United Kingdom

Imperial College Healthcare NHS Trust - Hammersmith Hospital, London, , United Kingdom

The Christie NHS Foundation Trust, Manchester, , United Kingdom

Oxford University Hospitals NHS Trust - Churchill Hospital, Oxford, , United Kingdom

Contact Details

Name: Simran Bedi Singh

Affiliation: CTI BioPharma

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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