Study Title: PARADIGM-2
Study Description: OlaPArib and RADIotherapy or olaparib and radiotherapy plus temozolomide in newly-diagnosed Glioblastoma stratified by MGMT status: 2 parallel phase I studies
Study Design: 2 parallel, multi-centre, open-label, non-randomised, dose-escalation phase I studies within one clinical trial protocol
Primary Endpoint:- Parallel 1 (methylated MGMT promoter status) - to establish the maximum tolerated dose of olaparib in combination with radiotherapy and temozolomide with which to progress to a randomised phase 2 study.
- Parallel 2 (unmethylated MGMT promoter status) - to establish the maximum tolerated dose of olaparib in combination with radiotherapy with which to progress to a randomised phase 2 study.
Trial Status: Open to recruitment
Chief Investigator: Professor Anthony Chalmers, Beatson West of Scotland Cancer Centre, Glasgow
Sponsor: University of Glasgow / Greater Glasgow and Clyde Health Board
Date Opened: Planned to open July 2016
Planned Closure Date: July 2018
Target Recruitment:- 25-40 patients in Parallel 1
- 19-28 patients in Parallel 2
Open to New Sites: No
Contact Details:
Lorna Sweeting (Project Manager)
Tel: 00 44 (0) 141 301 7194
E-mail: [email protected]
Susan Dillon (Clinical Trial Coordinator)
Tel: 00 44 (0) 141 301 7232
E-mail: [email protected]
Cancer Research UK Clinical Trials Unit Glasgow
Beatson West of Scotland Cancer Centre
1053 Great Western Road
Glasgow G12 0YN
Fax: 00 44 (0) 141 301 7946
Click here to download the Initiation Slides
For queries concerning Pharmacovigilance, or the documents to refer to for the clinical management of trial patients or those that are acting as the Reference Safety Information please contact:
The Pharmacovigilance Team email: [email protected] or
Telephone: 0141 211 0352/0203/3567/3968 or 0141 232 2068
Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) being used for the study (if applicable): 4.03
Click here to download the CTCAE
