Status:
WITHDRAWN
Phase I Study of Olaparib With Cisplatin Based Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck
Lead Sponsor:
University College, London
Collaborating Sponsors:
AstraZeneca
Conditions:
Carcinoma, Squamous Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
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 Car...
Eligibility Criteria
Inclusion
- Histologically confirmed high risk, locally advanced HNSCC patients (TNM staging: T-any N2/3 M0, bulky T3 or T4 N-any M0) who would normally be offered cisplatin-based radical chemoradiotherapy
- Estimated life expectancy of at least 12 weeks
- WHO performance status of 0 or 1
- Aged ≥18 years of age
- Adequate major organ function
- Willing to use contraception for the duration of the trial treatment and for six months after completion of treatment
- Able to give informed consent
- Willing and able to comply with the protocol for the duration of the study
Exclusion
- Head \& neck cancers of the following types:
- Nasopharyngeal and paranasal sinus tumours,
- Oral squamous cell carcinomas (tumours of the oral cavity),
- Human Papilloma Virus positive oropharyngeal tumours (tonsillar and tongue base tumours)
- Confirmed distant metastatic disease
- Previous chemotherapy or radiotherapy for the treatment of HNSCC tumour
- Previous therapy with a PARP inhibitor
- Pre-existing gastrointestinal disorders that may interfere with the delivery or absorption of olaparib
- Grade 3 or 4 peripheral neuropathy
- Significant hearing difficulties or tinnitus (deaf patients can be included)
- The current use of drugs which are known to inhibit or induce CYP3A4
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01491139
Last Update
May 30 2012
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