drugset / Trial / NCT01926587
Phase II Part 2 Expansion of Oral Rigosertib in Combination With Azacitidine
NaSingle-groupOpen-labelTreatment
Summary
This study, is a Phase I/II clinical trial in three parts: Phase I Dose Escalation, Phase II, Part 1 RPTD Cohort, and Phase II, Part 2 Expansion. The first two parts have been completed. The Phase II, Part 2 Expansion will assess if treatment with rigosertib in combination with azacitidine, has measurable effects in patients with myelodysplastic syndrome (MDS). Safety of patients is an objective throughout all parts of the study.
Timeline
- Start
- 2013-08
- Primary completion
- 2020-12-08
- Completion
- 2021-02-16
Publications
- Background 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.
- Background Chaurasia, P. et al. Rigosertib in Combination with Azacitidine Modulates Epigenetic Pathways and can Overcome Clinical Resistance to Hypomethylating Agents in Myelodysplastic Syndromes (MDS). Leukemia Research , Volume 55 , S121, April 2017; MDS 2017.
- 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.
- Results Navada S, Garcia-Manero G. Combination of Oral Rigosertib and Injectable Azacitidine in Patients with Myelodysplastic Syndromes (MDS): Results from a Phase II Study. Blood Dec 2016, 128 (22) 3167; ASH 2016.
- Results Navada, S. et al. Combination of Oral Rigosertib and Injectable Azacitidine in Patients with Myelodysplastic Syndromes (MDS). Leukemia Research , Volume 55 , S30, April 2017; MDS 2017.
- Navada SC, Garcia-Manero G, OdchimarReissig R, Pemmaraju N, Alvarado Y, Ohanian MN, John RB, Demakos EP, Zbyszewski PS, Maniar M, Woodman RC, Fruchtman SM, Silverman LR. Rigosertib in combination with azacitidine in patients with myelodysplastic syndromes or acute myeloid leukemia: Results of a phase 1 study. Leuk Res. 2020 Jul;94:106369. doi: 10.1016/j.leukres.2020.106369. Epub 2020 May 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | rigosertib | Small molecule | 140 mg | Oral |
| Subject | rigosertib | Small molecule | 280 mg | Oral |
| Subject | rigosertib | Small molecule | 840 mg | Oral |
| Subject | rigosertib | Small molecule | 1120 mg | Oral |
| Background | Azacitidine | Other / unclassified | 75 mg/m2 | Subcutaneous |