drugset / Trial / NCT01758731

Study of Olaparib With Radiation Therapy and Cetuximab in Advanced Head and Neck Cancer With Heavy Smoking History

NCT01758731

Phase 1 Completed 17 enrolled University of Colorado, Denver
NaSingle-groupOpen-labelTreatment

Summary

This is a research study that plans to learn more about the safety and tolerability of an investigational drug called Olaparib, in combination with radiation therapy and cetuximab. Hypothesis: Intensity modulated radiotherapy with concurrent C225 and Olaparib represents a feasible, biologically-based alternative to standard chemoradiation, with acceptable toxicity, for treatment of locally-advanced HNSCC in patients having a ≥ 10 pack-year smoking history.

Timeline

Start
2012-10-22
Primary completion
2016-12-05
Completion
2018-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Olaparib Small molecule 25 mg Oral
Subject Olaparib Small molecule 50 mg Oral
Subject Olaparib Small molecule 100 mg Oral
Subject Olaparib Small molecule 200 mg Oral
Background Cetuximab Monoclonal antibody 250 mg/m2 Intravenous