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
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
3
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials