drugset / Trial / NCT01538537
Safety of ON 01910.Na as a 3-day Infusion in Patients With Advanced Cancer
NaSingle-groupOpen-labelTreatment
Summary
The primary objective of this study is to determine the largest dose of ON 01910.Na (rigosertib sodium) that can be given safely as a 3-day continuous infusion once every 2 weeks (2-week cycle) in patients with advanced cancer.
Timeline
- Start
- 2006-08
- Primary completion
- 2010-10
- Completion
- 2012-01
Publications
- Results Ohnuma T, Lehrer D, Ren C, Cho SY, Maniar M, Silverman L, Sung M, Gretz HF 3rd, Benisovich V, Navada S, Akahoho E, Wilck E, Taft DR, Roboz J, Wilhelm F, Holland JF. Phase 1 study of intravenous rigosertib (ON 01910.Na), a novel benzyl styryl sulfone structure producing G2/M arrest and apoptosis, in adult patients with advanced cancer. Am J Cancer Res. 2013 Jun 20;3(3):323-38. Print 2013.
- 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 | 50 mg/m2 | Intravenous |
| Subject | rigosertib | Small molecule | 100 mg/m2 | Intravenous |
| Subject | rigosertib | Small molecule | 150 mg/m2 | Intravenous |
| Subject | rigosertib | Small molecule | 250 mg/m2 | Intravenous |
| Subject | rigosertib | Small molecule | 325 mg/m2 | Intravenous |
| Subject | rigosertib | Small molecule | 400 mg/m2 | Intravenous |
| Subject | rigosertib | Small molecule | 650 mg/m2 | Intravenous |
| Subject | rigosertib | Small molecule | 850 mg/m2 | Intravenous |
| Subject | rigosertib | Small molecule | 1050 mg/m2 | Intravenous |
| Subject | rigosertib | Small molecule | 1375 mg/m2 | Intravenous |
| Subject | rigosertib | Small molecule | 1700 mg/m2 | Intravenous |