drugset / Trial / NCT01758731
Study of Olaparib With Radiation Therapy and Cetuximab in Advanced Head and Neck Cancer With Heavy Smoking History
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |