drugset / Trial / NCT02107235
Platinum-based Chemoradiotherapy and Rigosertib in Head and Neck Cancer
NaSingle-groupOpen-labelTreatment
Summary
The working hypothesis is that oral rigosertib treatment when added to platinum-based Chemoradiotherapy (CRT) will improve progression-free survival for first-line patients with intermediate- or high-risk human papillomavirus negative positive (HPV (+)) Head and Neck Squamous Cell Carcinoma. This study will determine the highest safe dose of oral rigosertib that can be used with cisplatin and CRT. This study will also record any side effects that may occur and measure tumor sizes and how long patients live.
Timeline
- Start
- 2014-01
- Primary completion
- 2014-10
- Completion
- 2015-01
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | rigosertib | Small molecule | 70 mg | — |
| Subject | rigosertib | Small molecule | 140 mg | — |
| Subject | rigosertib | Small molecule | 280 mg | — |
| Background | Cisplatin | Other / unclassified | 40 mg/m2 | Intravenous |