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Platinum-based Chemoradiotherapy and Rigosertib in Head and Neck Cancer

NCT02107235 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2017-06-23

No results posted yet for this study

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.

Conditions

  • Head and Neck Neoplasms
  • Carcinoma, Squamous Cell

Interventions

DRUG

oral rigosertib

DRUG

cisplatin

RADIATION

Radiotherapy

Sponsors & Collaborators

  • Traws Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Antonio Jimeno, MD, PhD · University of Colorado, Denver

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-10-31
Completion
2015-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02107235 on ClinicalTrials.gov