Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study stopped due to issues surrounding development and formulation of olaparib
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Squamous Cell | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- single arm
- description
- All patients will receive induction chemotherapy (cisplatin and 5-FU), followed by cisplatin chemotherapy and radiotherapy in addition to oral olaparib. Induction chemotherapy (21 day cycle) * Drug: cisplatin 80mg/m2 (day 1) * Drug: 5-FU (fluorouracil) 1000mg/m2/day (day 1-4 continuous infusion) olaparib plus chemoradiotherapy (8 weeks) * Drug: olaparib * Drug: Cisplatin * Radiation
- interventionNames
- Drug: olaparib
- Drug: cisplatin
- Radiation: Intensity Modulated Radiotherapy
Primary outcomes (1)
- measure
- Frequency of dose limiting toxicities
- timeFrame
- 6 weeks post completion of treatment
Secondary outcomes (2)
- measure
- Complete response rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
Data not yet available