NCT02107235

Platinum-based Chemoradiotherapy and Rigosertib in Head and Neck Cancer

Phase I Study of Platinum-based Chemoradiotherapy (CRT) With Oral Rigosertib in Patients With Intermediate or High-risk Head and Neck Squamous Cell Carcinoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Traws Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multicenter, dose-escalating study of oral rigosertib administered with concurrent cisplatin and Radiotherapy in patients with intermediate- and high-risk Head and Neck Squamous Cell Carcinoma. Three rigosertib escalating cohorts (up to 6 patients per cohort) will be sequentially evaluated: 70 mg 3 times a day (TID), 140 mg TID and 280 mg TID. The total treatment course will be 8 weeks: 1 week of oral rigosertib alone (70 mg TID, 140 mg TID or 280 mg TID) followed by 7 weeks of concurrent administration of rigosertib, cisplatin and radiation therapy. After completion of treatment, patients will be followed for up to 36 months to document Progression-free Survival and Overall Survival.

Conditions

• Head and Neck Neoplasms
• Carcinoma, Squamous Cell

Interventions

Type	Name	Description
DRUG	oral rigosertib
DRUG	cisplatin
RADIATION	Radiotherapy

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-10-01
• Completion: 2015-01-01
• First posted: 2014-04-08
• Last updated: 2017-06-23

Locations

4 sites across 1 country: United States