09-07: 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

Print this page

09-07: 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

The primary efficacy objective is to determine the onset of hematological improvement (HI) according to the 2006 International Working Group (IWG) criteria (see Appendix 1), including RBC transfusion independence, erythroid response, and neutrophil or platelet response, within 24 weeks of starting treatment with oral rigosertib, in transfusion-dependent patients with myelodysplastic syndrome classified as Low or Intermediate-1 in the International Prognostic Scoring System (IPSS).

The secondary efficacy objectives are to evaluate rigosertib with respect to:
- Overall response (complete and partial responses) according to 2006 IWG criteria (see Appendix 1), including the onset and duration of response;
-Bone marrow response according to 2006 IWG criteria.

The safety of oral rigosertib administered to transfusion-dependent patients with Low or Int -1 will be evaluated.

Protocol Number021307
Principal InvestigatorDale Schaar
PhasePhase II
ScopeNational
Applicable Disease SitesLeukemia, other
Drugs InvolvedRigosertib
Participating InstitutionsRutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.