⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for Controlled Study of Rigosertib Versus Physician's Choice of Treatment in MDS Patients After Failure of an HMA

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

Study Description

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).

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Steven M. Fruchtman, MD

Affiliation: Traws Pharma, Inc.

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: