Open Label Study to Assess Efficacy and Safety of Olaparib in Confirmed Genetic BRCA1 or BRCA2 Mutation Pats

Status:	Active, not recruiting
Conditions:	Prostate Cancer, Ovarian Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - 127
Updated:	2/28/2019
Start Date:	February 21, 2010
End Date:	December 31, 2019

A Phase II, Open Label, Non Randomised, Non Comparative, Multicentre Study to Assess the Efficacy and Safety of Olaparib Given Orally Twice Daily in Patients With Advanced Cancers Who Have a Confirmed Genetic BRCA 1 and/or BRCA2 Mutation

To assess the efficacy of oral olaparib in patients with advanced cancer who have a confirmed
genetic BRCA1 and/or BRCA2 mutation, by assessment of tumour response

Inclusion Criteria:

- Confirmed documented deleterious or suspected deleterious BRCA mutation. (The presence
of a loss-of-function germline mutation in the BRCA1 and/or BRCA2 gene must be
confirmed prior to consent according to local practice).

- Confirmed malignant solid tumours for which no standard treatment exists

- At least one lesion (measurable and/or non measurable) at baseline that can be
accurately assessed by CT/MRI and is suitable for repeated assessment at follow up
visits

Exclusion Criteria:

- Any previous treatment with a PARP inhibitor, including olaparib

- Patients unable to swallow orally administered medication and patients with
gastrointestinal disorders likely to interfere with absorption of the study medication

- Patients receiving any systematic chemotherapy, radiotherapy (except for palliative
reasons) within 2 weeks from the last dose prior to study treatment (or a longer
period depending on the defined characteristics of the agents used)

We found this trial at

sites

Clinical Trial Facility in Melbourne

Melbourne,

from

Melbourne,