drugset / Trial / NCT02107235

Platinum-based Chemoradiotherapy and Rigosertib in Head and Neck Cancer

NCT02107235

Phase 1 Completed 2 enrolled Traws Pharma, Inc.
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

EvaluationDrugModalityDoseRoute
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