drugset / Trial / NCT02075034

Three Dosing Schedules of Oral Rigosertib in MDS Patients

NCT02075034

Phase 1 Withdrawn Traws Pharma, Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

This study will compare the dosing regimen of oral rigosertib, which has been used in other studies of lower risk Myelodysplastic Syndrome (MDS), with 2 new dosing regimens to determine if one of the new regimens gives improved results as measured by disease status, side effects, and analyses of blood and urine samples.

Timeline

Start
2014-05
Primary completion
2019-08
Completion
2019-11

Publications

  • Results Garcia-Manero G, Fenaux P. Comprehensive Analysis of Safety: Rigosertib in 557 Patients with Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML). Blood Dec 2016, 128 (22) 2011; ASH 2016.

Drugs

EvaluationDrugModalityDoseRoute
Subject rigosertib Small molecule 280 mg Oral
Subject rigosertib Small molecule 420 mg Oral
Subject rigosertib Small molecule 560 mg Oral