MedTrace Logo

Phase I Study of Olaparib With Cisplatin Based Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck

NCT01491139 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2012-05-30

No results posted yet for this study

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.

Conditions

  • Carcinoma, Squamous Cell

Interventions

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.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • University College, London

    lead OTHER

Principal Investigators

  • Martin D Forster, MBBS · University College London Hospitals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01491139 on ClinicalTrials.gov