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Brief Title: Efficacy and Safety of IV Rigosertib in MDS Patients With Excess Blasts Progressing After Azacitidine or Decitabine
Official Title: Phase IIIB, Open-label, Multi-Center Study of the Efficacy and Safety of Rigosertib Administered as 72-hour Continuous Intravenous Infusions in Patients With Myelodysplastic Syndrome With Excess Blasts Progressing On or After Azacitidine or Decitabine
Study ID: NCT01928537
Brief Summary: This study will examine the effect intravenously administered rigosertib has on the relationship between bone marrow blasts response and overall survival in myelodysplastic syndromes (MDS) patients who have 5-30% bone marrow blasts and who progressed on or after treatment with azacitidine or decitabine.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Stanford University Cancer Center, Stanford, California, United States
Rush University Medical Center, Chicago, Illinois, United States
University of Chicago Medicine, Chicago, Illinois, United States
University of Kansas Cancer Center and Medical Pavilion, Westwood, Kansas, United States
Greenbaum Cancer Center University of Maryland, Baltimore, Maryland, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Mayo Clinic, Rochester, Minnesota, United States
Montefiore Medical Center, Bronx, New York, United States
Mount Sinai Medical Center, New York, New York, United States
Columbia University Medical Center, New York, New York, United States
New York Presbyterian Hospital-Weill Cornell Medical College, New York, New York, United States
University of Texas Southwestern Medical Center-Parkland Hospital, Dallas, Texas, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Monash Health, Monash Medical Centre, Clayton, Victoria, Australia
Peter MacCallum Cancer Center, East Melbourne, Victoria, Australia
Royal Melbourne Hospital, Parkville, Victoria, Australia
Rigshospitalet, Department of Hematology, Copenhagen, Hovedstaden, Denmark
Aarhus University Hospital, Aarhus, Jylland, Denmark
HĂŽpital Saint-Louis, Service d'HĂ©matologie, Paris, IDF, France
Institute Paoli Calmettes, Marseille, , France
UniversitÀtsklinikum Frankfurt, Goethe UniversitÀt, Frankfurt, Hessen, Germany
University Hospital Carl Guslav Carus, Dresden, , Germany
Marien Hospital, Onkologie, DĂŒsseldorf, , Germany
UniversitÀtsmedizin Göttingen, Göttingen, , Germany
UniversitĂ€tsklinikum Köln Klinik I fĂŒr Innere Medizin, Köln, , Germany
Technische UniversitĂ€t MĂŒnchen, III. Medizinische Klinik, MĂŒnchen, , Germany
Azienda Ospedaliero-Universitaria Careggi, Firenze, , Italy
AOU Maggiore della CaritĂ , SCUD Ematologia, Novara, , Italy
Policlinico Umberto 1, Universita "Sapienza", Rome, , Italy
Hospital UniversitĂĄrio de Salamanca, Salamanca, , Spain
SkÄne University Hospital,, Lund, SkÄne, Sweden
Sahlgrenska University Hospital, Gothenberg, VÀstra Götalandsregionen, Sweden
Karolinska University Hospital, Huddinge, Stockholm, , Sweden
Name: Steven M. Fruchtman, MD
Affiliation: Traws Pharma, Inc.
Role: STUDY_CHAIR