Spots Global Cancer Trial Database for Oral Rigosertib in Low Risk MDS Patients Refractory to ESAs
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Trial Identification
Brief Title: Oral Rigosertib in Low Risk MDS Patients Refractory to ESAs
Official Title: A Single-arm Study to Assess the Efficacy and Safety of Oral Rigosertib in Transfusion-dependent, Low or Intermediate-1, Myelodysplastic Syndrome Patients Based on the International Prognostic Scoring System
Study ID: NCT01904682
Conditions
Interventions
Study Description
Brief Summary: The study will enroll low risk MDS patients who need red blood cell transfusions and who are refractory to or are not using erythropoiesis-stimulating agents. The purpose of the study is to determine whether oral rigosertib treatment results in hematological improvements according to the 2006 International Working Group criteria in these patients. The study will also record any side effects that may occur during the study.
Detailed Description: This will be a Phase II, single-arm, multicenter study (approximately 15 centers). Approximately 40 transfusion-dependent patients with Low- or Int-1 risk Myelodysplastic Syndrome (MDS) by International Prognostic Scoring System (IPSS) will be enrolled and treated with oral rigosertib administered twice daily for 21 consecutive days of a 21-day cycle (continuous regimen) in order to obtain at least 35 evaluable patients treated for at least 8 weeks. Patients will take 560 mg rigosertib (two 280 mg capsules) in the morning and 280 mg (one 280 mg capsule) in the afternoon, in fasting conditions. All patients on intermittent regimen at the time of Amendment 2 of the Protocol will be switched to the continuous regimen, including patients on reduced doses.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Stanford University School of Medicine, Stanford, California, United States
Anschutz Cancer Pavilion University of Colorado, Aurora, Colorado, United States
Washington Cancer Institute at Medstar Washington Hospital Center, Washington, District of Columbia, United States
The University of Chicago, Chicago, Illinois, United States
Greenbaum Cancer Center University of Maryland, Baltimore, Maryland, United States
Mayo Clinic, Rochester, Minnesota, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Mount Sinai Medical Center, New York, New York, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Hôpital Saint-Louis, Service d'Hématologie, Paris, IDF, France
Heinrich Heine Universität, Düsseldorf, NRW, Germany
Universitätsklinikum Köln, Köln, NRW, Germany
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Dresden, Saxony, Germany
Contact Details
Name: Steven M. Fruchtman, MD
Affiliation: Traws Pharma, Inc.
Role: STUDY_CHAIR
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