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Brief Title: Controlled Study of Rigosertib Versus Physician's Choice of Treatment in MDS Patients After Failure of an HMA
Official Title: A Phase III, International, Randomized, Controlled Study of Rigosertib Versus Physician's Choice of Treatment in Patients With Myelodysplastic Syndrome After Failure of a Hypomethylating Agent
Study ID: NCT02562443
Brief Summary: The study's primary objective \[in a population of patients with MDS after failure of treatment with azacitidine (AZA) or decitabine (DAC)\], is to compare the overall survival (OS) of patients in the rigosertib group vs the Physician's Choice group, in all patients and in a subgroup of patients with IPSS-R very high risk.
Detailed Description: This is a Phase III, open-label, randomized, controlled, international study. Approximately 360 patients \< 82 years of age with MDS classified as RAEB-1, RAEB-2, or RAEB-t who received AZA or DAC for ≤ 9 months and/or ≤ 9 cycles over 12 months and had their last dose of AZA or DAC within 6 months prior to screening will be stratified by: * Very high risk (VHR) vs non-VHR per IPSS-R, and * Geographic region (North America vs Europe vs Asia; because approved products and standard of care may vary by region), and randomly assigned in a 2:1 ratio to one of the following 2 treatment groups: * Rigosertib 1800 mg/24 hr administered as a 72 hr CIV infusion on Days 1, 2, and 3 of a 2 week cycle for the first 8 cycles, and on Days 1, 2, and 3 of a 4-week cycle thereafter (N = approximately 240 patients); * Physician's Choice of alternative treatment, which may include any approved or standard-of-care therapy that the patient has not shown to be hypersensitive to, based on frequently used treatment for MDS, as per institutional guidelines, after receipt of HMAs (N = approximately 120 patients). The drugs used in the Physician's Choice arm should be used according to the recommendations, if clinically appropriate, provided in the corresponding Summary of Product Characteristics (SmPC) and Prescribing Information of these drugs. Experimental therapies are not allowed on the PC arm. Patients will be treated until 2006 IWG progression criteria are met (ie, 50% increase of BM blasts or worsening of cytopenias) or until an unacceptable toxicity or intolerance. For all randomized patients who discontinue study treatment, subsequent therapies with their start and end dates, as well as survival time after treatment discontinuation, will be documented at least monthly until death. Patients in the PC group who progress will not be allowed to cross over to rigosertib. All patients in both treatment groups will be allowed, as medically justified, access to RBC and platelet transfusions and to growth factors (granulocyte colony-stimulating factor (G-CSF), erythropoietin, and thrombopoietin).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
UC San Diego Moores Cancer Center, La Jolla, California, United States
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
UCLA Medical Center, Los Angeles, California, United States
Cancer Specialists of North Florida, Fleming Island, Florida, United States
UF Health Shands Cancer Hospital, Gainesville, Florida, United States
Mid Florida Hematology and Oncology Centers, Orange City, Florida, United States
Advanced Research Institute, Inc, Saint Petersburg, Florida, United States
Rush University Medical Center, Chicago, Illinois, United States
University of Illinois Cancer Center, Chicago, Illinois, United States
Loyola University Chicago at Loyola University Medical Center, Maywood, Illinois, United States
Indiana University Health Hospital, Indianapolis, Indiana, United States
The University of Kansas Cancer Center, Westwood, Kansas, United States
Tulane Medical Center, New Orleans, Louisiana, United States
University of Maryland Greenebaum Cancer Center, Baltimore, Maryland, United States
Tufts Medical Center, Boston, Massachusetts, United States
University of Minnesota Physicians Bone Marrow Transplant Clinic, Minneapolis, Minnesota, United States
Mayo Clinic, Rochester, Minnesota, United States
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
The Valley Hospital, Ridgewood, New Jersey, United States
Mount Sinai School of Medicine, New York, New York, United States
Columbia University Medical Center, New York, New York, United States
New York Medical College, Valhalla, New York, United States
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Albert Einstein Medical Center, Cancer Center, Philadelphia, Pennsylvania, United States
Greenville Health System (GHS) Cancer Institute, Greenville, South Carolina, United States
UT Southwestern Medical Center, Dallas, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Emily Couric Clinical Cancer Center, Charlottesville, Virginia, United States
Seattle Cancer Care Alliance (SCCA), Seattle, Washington, United States
University of Wisconsin Clinical Science Center, Madison, Wisconsin, United States
Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin, United States
Icon Cancer Care Icon South Brisbane, South Brisbane, Queensland, Australia
Royal Hobart Hospital, Hobart, Tasmania, Australia
Monash Health, Monash Medical Centre, Melbourne, Victoria, Australia
Hospital of the Elisabethinen Linz GmbH, Linz, , Austria
Salzburg University Hospital, Salzburg, , Austria
Hanusch Hospital, Vienna, , Austria
Antwerp Hospital Network Stuivenberg, Antwerp, , Belgium
University Hospital Ghent, Ghent, , Belgium
University Hospital Leuven, Campus Gasthuisberg, Leuven, , Belgium
CHU UCL Namur - Site Godinne, Yvoir, , Belgium
CancerCare Manitoba, Winnipeg, Manitoba, Canada
Sunnybrook Research Institute, Toronto, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Jewish General Hospital, Montreal, Quebec, Canada
Klinički bolnički centar Osijek, Osijek, , Croatia
Clinical Hospital Merkur, Zagreb, , Croatia
Klinički bolnicki centar Sestre milosrdnice, Zagreb, , Croatia
Klinički bolnički centar Zagreb, Zagreb, , Croatia
University Hospital Brno, Brno, , Czechia
University Hospital Hradec Kralove, Hradec Kralove, , Czechia
University Hospital Ostrava, Department of Hematooncology, Ostrava Poruba, , Czechia
General University Hospital, Prague 2, , Czechia
Institute of Hematology and Blood Transfusion, Prague 2, , Czechia
North Estonia Medical Centre, Tallinn, , Estonia
Tartu University Hospital, Tartu, , Estonia
CHD Vendée, La Roche Sur Yon Cedex 9, , France
Hôpital Claude Huriez, CHRU Lille, Lille Cedex, , France
Institut Paoli-Calmettes, Marseille, , France
Hôpital l'Archet 1, Nice Cedex 3, , France
Institut de Cancérologie du Gard, Nimes Cedex 9, , France
Hôpital Saint Louis, Paris Cedex 10, , France
Centre Hospitalier Lyon-Sud, Pierre-Bénite, , France
Hôpital civil, Strasbourg, Strasbourg Cedex, , France
CHRU Tours Hôspital Bretonneau, Tours, , France
Universitätsklinikum Carl Gustav Carus, Dresden, , Germany
Marien Hospital Düsseldorf, Düsseldorf, , Germany
Universitätsklinikum Frankfurt am Main, Frankfurt, , Germany
Semmelweis University Medical School, Budapest, , Hungary
Somogy County Kaposi Mór Teaching Hospital, Kaposvár, , Hungary
Jósa András Teaching Hospital, Nyíregyháza, , Hungary
University of Pécs 1st Department of Internal Medicine, Pécs, , Hungary
Hemato Oncology Clinic Pvt. Ltd, Ahmedabad, Gujarat, India
St. John's Medical College Hospital, Bangalore, Karnataka, India
Tata Memorial Hospital, Mumbai, Maharashtra, India
Jaslok Hospital and Research Center, Mumbai, Maharashtra, India
Sahyadri Clinical Research and Development Center, Pune, Maharashtra, India
Christian Medical College, Vellore, Tamil Nadu, India
Institute Of Hematology And Transfusion Medicine, Kolkata, West Bengal, India
Cork University Hospital, Cork, , Ireland
Adelaide and Meath Hospital, Incorporating the National Children's Hospital, Dublin, , Ireland
University Hospital Waterford, Waterford, , Ireland
Ha'Emek Medical Center, 'Afula, , Israel
Soroka University Medical Center, Beer Sheva, , Israel
Rambam Medical Center, Haifa, , Israel
Hadassah Medical Center, Jerusalem, , Israel
Kaplan Medical Center, Rehovot, , Israel
Sourasky Medical Center, Tel Aviv, , Israel
The Chaim Sheba Medical Center, Tel Hashomer, , Israel
Polyclinic S. Orsola-Malpighi, Bologna, , Italy
Azienda Ospedaliera Spedali Civili, Brescia, , Italy
Azienda Ospedaliero Universitaria Careggi, Firenze, , Italy
Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara, , Italy
A.O.U. Pisana, Divisione di Ematologia - University Hospital of Pisa, Pisa, , Italy
Policlinico Universitario Tor Vergata, Roma, , Italy
Ospedale S. Eugenio - S. Eugenio Hospital, Roma, , Italy
Azienda Ospedaliera Santa Maria di Terni, Terni, , Italy
Cittá della Salute e della Scienza di Torino, Torino, , Italy
Kokura Memorial Hospital, Kitakyushu, Fukuoka, Japan
Chugoku Central Hospital of the Mutual Aid Association of Public School Teachers, Fukuyama, Hiroshima, Japan
Sapporo Medical University Hospital, Sapporo, Hokkaido, Japan
Kanazawa University Hospital, Kanazawa, Ishikawa, Japan
Yokohama City University Hospital, Yokohama-shi, Kanagawa, Japan
Shimane University Hospital, Izumo, Shimane, Japan
Japanese Red Cross Medical Center, Shibuya, Tokyo, Japan
Akita University Hospital, Akita, , Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Bunkyo-ku, , Japan
National Hospital Organization Kyushu Cancer Center, Fukuoka-shi, , Japan
Kagoshima University Hospital, Kagoshima, , Japan
Tokai Central Hospital of the Mutual Aid Association of Public School Teachers, Kakamigahara, , Japan
Saitama Medical Center, Kawagoe, , Japan
Kobe City Hospital Organization Kobe City Medical Center General Hospital, Kobe, , Japan
National Hospital Organization Kumamoto Medical Center, Kumamoto, , Japan
Japanese Red Cross Kyoto Daini Hospital, Kyoto, , Japan
Nagasaki University Hospital, Nagasaki, , Japan
Japanese Red Cross Nagoya Daini Hospital, Nagoya-shi, , Japan
Niigata University Medical and Dental Hospital, Niigata, , Japan
Oita Prefectural Hospital, Oita, , Japan
National Hospital Organization Okayama Medical Center, Okayama, , Japan
Kindai University Hospital, Osakasayama-shi, , Japan
Hokkaido University Hospital, Sapporo-shi, , Japan
Tohoku University Hospital, Sendai-shi, , Japan
NTT Medical Center Tokyo, Shinagawa-ku, , Japan
Tokyo Medical University Hospital, Shinjuku-ku, , Japan
Dokkyo Medical University Hospital, Tochigi, , Japan
Tokushima University Hospital, Tokushima, , Japan
Yamagata University Hospital, Yamagata, , Japan
Saiseikai Yokohamashi Nanbu Hospital, Yokohama-shi, , Japan
University of Fukui Hospital, Yoshida, , Japan
Independent Public Healthcare Facility University Hospital in Cracow, Clinical Department of Hematology, Kraków, , Poland
Independent Public Health Care Facility of the Ministry of Internal Affairs with Warmia and Mazury Oncology Centre in Olsztyn, Olsztyn, , Poland
Ludwik Rydygier Provinicial Hospital in Suwalki, Department of Clinical Oncology and Hematology, Suwalki, , Poland
MTZ Clinical Research Sp. z o.o., Warsaw, , Poland
Independent Public University Hospital No. 1 in Wroclaw, Department of Hematology, Blood Cancers and Bone Marrow, Wroclaw, , Poland
State Autonomous Healthcare Institution of Kemerovo region "Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev",, Kemerovo, , Russian Federation
State Budgetary Healthcare Institution of Moscow City, Moscow, , Russian Federation
FSBI "Russian Scientific Research Hematology and Tranfusiology Institute of the Federal Biomedical Agency", Saint Petersburg, , Russian Federation
Hospital Son Llàtzer, Palma de Mallorca, Balearic Islands, Spain
Hospital Duran i Reynals - Instituto Catalán de Oncología, Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Hospital Universitari Germans Trias i Pujol, Barcelona, , Spain
Hospital Universitario Gregorio Marañón, Madrid, , Spain
Fundación Jiménez Díaz, Madrid, , Spain
Hospital Universitario Virgen de la Victoria, Málaga, , Spain
Hospital Universitario Salamanca, Salamanca, , Spain
Hospital Universitari i Politècnic La Fe, Valencia, , Spain
Karolinska University Hospital, Stockholm, Huddinge, Sweden
Skåne University Hospital, Department of Hematology, Lund, , Sweden
Uppsala University Hospital, Uppsala, , Sweden
Linköping University Hospital, Linköping, Östergötland, Sweden
University Hospital and University of Bern; Inselspital Bern, Bern, , Switzerland
University Hospital Zurich, Zurich, , Switzerland
Royal Bournemouth Hospital, Bournemouth, Dorset, United Kingdom
Aberdeen Royal Infirmary, Aberdeen, Scotland, United Kingdom
The Royal Liverpool University Hospital, Liverpool, , United Kingdom
St Bartholomew's Hospital, Barts Health NHS Trust, London, , United Kingdom
King's College Hospital NHS Foundation Trust, London, , United Kingdom
Name: Steven M. Fruchtman, MD
Affiliation: Traws Pharma, Inc.
Role: STUDY_CHAIR