Spots Global Cancer Trial Database for Pacritinib Versus Best Available Therapy to Treat Patients With Myelofibrosis and Thrombocytopenia
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Trial Identification
Brief Title: Pacritinib Versus Best Available Therapy to Treat Patients With Myelofibrosis and Thrombocytopenia
Official Title: A Randomized Controlled Phase 3 Study of Oral Pacritinib Versus Best Available Therapy in Patients With Thrombocytopenia and Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis
Study ID: NCT02055781
Study Description
Brief Summary: Phase 3, randomized, controlled study to evaluate the safety and efficacy of oral pacritinib compared to Best Available Therapy (BAT) in patients with thrombocytopenia and primary or secondary myelofibrosis.
Detailed Description: Multicenter, randomized, controlled, phase 3 trial comparing the safety and efficacy of pacritinib with that of BAT in patients with thrombocytopenia and primary or secondary myelofibrosis. Approximately 300 eligible patients will be randomized in a 1:1:1 allocation to pacritinib 400 mg dosed QD, pacritinib 200 mg dosed BID, or BAT (includes any physician-selected treatment for myelofibrosis, such as approved JAK2 inhibitors administered according to package insert for patients with thrombocytopenia, and may include any treatment received before study entry). Spleen volume will be measured by MRI or CT at baseline and every 12 weeks thereafter. An independent radiology facility (IRF), blind to treatment assignments, will measure spleen volumes. Patients will also be followed for safety, Leukemia Free Survival (LFS), Overall Survival (OS), frequency of red blood cell (RBC) and platelet transfusions, and other exploratory endpoints. An Independent Data Monitoring Committee (IDMC) will evaluate the safety of pacritinib.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic Arizona, Scottsdale, Arizona, United States
Arizona Clinical Research Center, Tucson, Arizona, United States
City of Hope, Duarte, California, United States
Moores Cancer Centre, La Jolla, California, United States
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
Stanford Cancer Center, Stanford, California, United States
Rocky Mountain Cancer Center, Boulder, Colorado, United States
George Washington University- Medical Faculty Associates, Washington, District of Columbia, United States
SCRI- Florida Cancer Specialists South Region, Fort Myers, Florida, United States
SCRI - Florida Cancer Specialists North Region, Saint Petersburg, Florida, United States
H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States
Northwestern University, Chicago, Illinois, United States
Carle Cancer Center, Urbana, Illinois, United States
Indiana University Goshen Cancer Centre, Goshen, Indiana, United States
Investigative Clinical Research of Indiana, Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
Siouxland Hematology-Oncology Associates, L.L.P (SHOA), Sioux City, Iowa, United States
Norton Cancer Institute, Suburban, Louisville, Kentucky, United States
St Joseph Mercy Hospital, Ann Arbor, Michigan, United States
University of Michigan, Ann Arbor, Michigan, United States
Henry Ford Health System, Detroit, Michigan, United States
Providence Cancer Institute, Southfield, Michigan, United States
Washington University School of Medicine Division of Oncology, Saint Louis, Missouri, United States
Nebraska Hematology-Oncology, P.C., Lincoln, Nebraska, United States
Hackensack University, Hackensack, New Jersey, United States
Hematology-Oncology Associates of Northern Jersey, Morristown, New Jersey, United States
New Mexico Cancer Care Alliance, Albuquerque, New Mexico, United States
Mount Sinai Medical Center, New York, New York, United States
Columbia University Medical Center, New York, New York, United States
Stony Brook University Medical Center, Stony Brook, New York, United States
SCRI-Oncology Hematology Care, Cincinnati, Ohio, United States
Cleveland Clinic-Taussig Cancer Center, Cleveland, Ohio, United States
University of Oklahoma, Oklahoma City, Oklahoma, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Upstate Oncology Associates, Greenville, South Carolina, United States
Sarah Cannon Research Institute (SCRI), Nashville, Tennessee, United States
Texas Onocolgy-Baylor Sammons Cancer Center, Dallas, Texas, United States
UT Southwestern Medical Center, Dallas, Texas, United States
UTMB Galveston, Galveston, Texas, United States
Houston Methodist, Houston, Texas, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Cancer Care Centers of South Texas, San Antonio, Texas, United States
Huntsman Cancer Hospital, Salt Lake City, Utah, United States
Virginia Cancer Specialists, Leesburg, Virginia, United States
Providence Regional Cancer Partnership, Everett, Washington, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Green Bay Oncology, Green Bay, Wisconsin, United States
Froedtert Hospital and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
St George Hospital, Kogarah, New South Wales, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Box Hill Hospital, Box Hill, Victoria, Australia
Monash Health - Monash Medical Centre, Clayton, Victoria, Australia
Perth Blood Institute, Nedlands, Western Australia, Australia
Haematology and Oncology Clinics of Australia, Chermside, , Australia
Prince of Wales Hospital, Randwick, , Australia
Centre Hospitalier de Jolimont-Lobbes, Haine-Saint-Paul, Hainaut, Belgium
ZNA - Stuivenberg, Antwerpen, , Belgium
AZ Sint Jan Brugge-Oostende AV, Brugge, , Belgium
Hopital Brugmann, Brussels, , Belgium
Cliniques Universitaires St-Luc, Bruxelles, , Belgium
St Augustinus, Wilrijk, , Belgium
UC Louvain, Yvoir, , Belgium
Saint John Regional Hospital, Saint John, New Brunswick, Canada
Princess Margaret Cancer Center, Toronto, Ontario, Canada
Fakultní nemocnice Brno, Brno, NAP, Czechia
Faculty Hospital Olomouc, Olomouc, NAP, Czechia
Fakultní nemocnice Plzeň, Plzeň, NAP, Czechia
University Hospital Hradec Kralove, Králová, , Czechia
Chu d'Amiens Hopital Sud, Amiens, Cedex 1, France
Hôpital Caremeau, Nimes, Cedex 9, France
CHU Rennes, Rennes, Cedex 9, France
CHU Purpan, Toulouse, Cedex 9, France
CH de Mulhouse, Mulhouse, Cedex, France
CHU de CAEN, Caen, , France
Centre Hospitalier de Lens, Lens, , France
Hopital l'Archet, CHU de Nice, Nice, , France
Saint Antoine Hospital, Paris, , France
Centre Hospitalier Lyon Sud, Pierre Benite, , France
CHU de Strasbourg, Strasbourg, , France
Institut Gustave Roussy, Villejuif Cedex, , France
Charite-Medical University, Berlin, , Germany
Gemeinschaftspraxis Hämatologie/Onkologie, Dresden, , Germany
University Hospital Essen, Essen, , Germany
Uniklinik Freiburg, Freiburg, , Germany
Universitatsklinikum Halle (Saale), Halle (Saale), , Germany
Klinik I fur Innere Medizin, Universitat Koln, Koln, , Germany
University Hospital Leipzig, Leipzig, , Germany
Städtisches Klinikum München GmbH, Munchen, , Germany
University of Munster, Munster, , Germany
University Hospital Ulm, Ulm, , Germany
Semmelweis Egyetem AOK, Budapest, , Hungary
University of Debrecen, Belgyogyaszati Intezet, Debrecen, , Hungary
Bekes Megyei Pandy Kalman Korhaz, Gyula, , Hungary
Kaposi Mór Oktató Kórház, Kaposvár, , Hungary
SZTE II. sz Belgyogyoszati Klinika es Kardiologiai Kozpont, Szeged, , Hungary
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelőint, Szolnok, , Hungary
University Hospital Maastricht, Maastricht, , Netherlands
Erasmus MC, Rotterdam, , Netherlands
Auckland District Health Board, Auckland City Hospital, Auckland, , New Zealand
Middlemore Hospital, Auckland, , New Zealand
Canterbury District Health Board, Christchurch, , New Zealand
North Shore Hospital, Takapuna, , New Zealand
CCDHB - Wellington Hospital, Wellington, , New Zealand
Bashkir State Medical University, Ufa, Republic Of Bashkortostan, Russian Federation
Saratov State Medical University, Saratov, Saratov Region, Russian Federation
National Haematology Research Center, Moscow, , Russian Federation
Republican Hopsital n.a. V.A. Baranov, Petrozavodsk, , Russian Federation
Ryazan Regional Clinical Hospital, Ryazan, , Russian Federation
Russian Research Institute of Hematology and Transfusiology, St. Petersburg, , Russian Federation
Military Medical Academy n.a. S.M. Kirov, St. Petersburg, , Russian Federation
Royal Liverpool University Hospital, Liverpool, Merseyside, United Kingdom
Belfast Health and Social Care Trust, Belfast, N. Ireland, United Kingdom
Birmingham Heartlands Hospital, Birmingham, , United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Leicester Royal Infirmary, Leicester, , United Kingdom
Guy's Hospital, London, , United Kingdom
Hammersmith Hosp - ICH NHS Trust, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Oxford University Hospitals NHS Trust, Oxford, , United Kingdom
Royal Hallamshire Hospital, Sheffield, , United Kingdom
Contact Details
Name: Simran Singh
Affiliation: Sr. Director, Head of Clinical Operations
Role: STUDY_DIRECTOR
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