Olala Trial
Research type
Research Study
Full title
Olala Trial: A Retrospective/Prospective Analysis of Characterisation of the Long-Term Responders on Olaparib in Solid Tumours
IRAS ID
219928
Contact name
Bradly G. Wouters
Contact email
Sponsor organisation
University Health Network
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
In order to better define the clinical and molecular profile of patients who respond well to olaparib, we propose to analyse the ovarian cancer patients who had an exceptionally durable response to olaparib of at least 2 years. Moreover, in order to take into account the different settings in which olaparib was prescribed in the different trials, patients who have had a durable response to PARPi of longer than 2 standard deviations beyond the median response in the appropriate clinical cohort will be also considered for analyses. This response duration cut off will allow analysing the results (i.e platinum sensitive versus platinum resistant subsets as well as maintenance therapy groups versus treatment introduced at disease progression). Patient who were off olaparib due to toxicities but remain on durable response for at least 2 years or longer than standard deviations beyond the median response will be also included in the long-term responder group.
We hypothesize that ovarian cancer patients with exceptional long response to olaparib share similar molecular/clinical features which differentiate them from the majority of epithelial ovarian cancers and identification of these features may lead to a better understanding of responsiveness to PARPi. The comparison with patients who had a short time of benefit from olaparib may lead to a better understanding of PARPi resistance.REC name
South East Scotland REC 02
REC reference
17/SS/0056
Date of REC Opinion
9 Nov 2017
REC opinion
Further Information Favourable Opinion