Trials / Withdrawn
WithdrawnNCT01491139
Phase I Study of Olaparib With Cisplatin Based Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck
A Phase I/II Study of Olaparib in Addition to Cisplatin Based Concurrent Chemoradiotherapy for Patients With High Risk Locally Advanced Squamous Cell Carcinoma of the Head and Neck (HNSCC)
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- University College, London · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this study is to find the safe dose and best dosing schedule of olaparib to give in combination with cisplatin based chemoradiotherapy (CRT) in patients with locally advanced head and neck cancer. The dose decided on in this part of the study will become the recommended dose for the randomised Phase II trial.
Detailed description
This is a dose escalating Phase I/II trial evaluating the safety and tolerability of the addition of olaparib to CRT in high risk locally advanced human papillomavirus (HPV) negative Squamous Cell Carcinoma of the Head and Neck (HNSCC). A fixed dose of weekly cisplatin and intensity-modulated radiation therapy (IMRT) will be used, with doses of olaparib escalating for consecutive days and both dose level and duration will be increased through each cohort. This Phase I trial will assess how olaparib, a poly ADP ribose polymerase (PARP) inhibitor is tolerated when added to standard chemoradiotherapy treatment. Patients will be recruited from sites in the UK only. A placebo controlled, randomised Phase II trial will follow once the recommended dose and schedule of olaparib has been established.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | olaparib | Given twice daily. Exposure will escalate by daily dose and duration. |
| DRUG | cisplatin | Dose will be 35mg/m2 i.v. once weekly. |
| RADIATION | Intensity Modulated Radiotherapy | Total dose will be 70Gy in 35 fractions over 7 weeks. |
Timeline
- First posted
- 2011-12-13
- Last updated
- 2012-05-30
Source: ClinicalTrials.gov record NCT01491139. Inclusion in this directory is not an endorsement.