drugset / Trial / NCT01048619
Safety and Pharmacokinetic Study of Oral ON 01910.Na in Patients With Myelodysplastic Syndrome
NaSingle-groupOpen-labelTreatment
Summary
In other clinical studies, ON 01910.Na has been safely given intravenously to Patients with advanced cancers. However, to treat some Patients, it may be better if ON 01910.Na could be given by mouth. This study will determine if it is safe to give ON 01910.Na by mouth, what is the highest dose can be safely given by mouth, and how much of the drug gets from the stomach into the blood stream when it is given by mouth.
Timeline
- Start
- 2009-12
- Primary completion
- 2014-11
- Completion
- 2015-12
Publications
- Results Navada SC, Silverman LR. The safety and efficacy of rigosertib in the treatment of myelodysplastic syndromes. Expert Rev Anticancer Ther. 2016 Aug;16(8):805-10. doi: 10.1080/14737140.2016.1209413. Epub 2016 Jul 15.
- 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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | rigosertib | Small molecule | 70 mg | Oral |
| Subject | rigosertib | Small molecule | 88 mg | Oral |
| Subject | rigosertib | Small molecule | 105 mg | Oral |
| Subject | rigosertib | Small molecule | 140 mg | Oral |
| Subject | rigosertib | Small molecule | 280 mg | Oral |
| Subject | rigosertib | Small molecule | 560 mg | Oral |
| Subject | rigosertib | Small molecule | 700 mg | Oral |
| Subject | rigosertib | Small molecule | 800 mg/m2 | Oral |