| Trial name or title | Olaparib monotherapy in patients with BRCA mutated ovarian cancer following first line platinum based chemotherapy |
| Methods | A phase III, randomised, double‐blind, placebo‐controlled, multicentre study |
| Participants | Patients with BRCA mutated advanced (FIGO Stage III‐IV) ovarian cancer following first‐line platinum‐based chemotherapy |
| Interventions | Olaparib/placebo tablets po 300 mg twice daily for up to 2 years or until objective radiological disease progression as per RECIST as assessed by the investigator. Patients with evidence of stable disease (or those who have progressed), may continue on treatment beyond 2 years, if in the patient's best interest. Dose reduction to 250 mg and subsequently 200 mg is permitted following confirmation of toxicity |
| Outcomes | Progression‐free survival (PFS) by central review of RECIST data Overall survival Quality of life analysis Safety and tolerability |
| Starting date | August 2013 |
| Contact information | Elizabeth Lowe, AstraZeneca: ClinicalTrialTransparency@astrazeneca.com |
| Notes | Estimated completion: January 2022; estimated enrolment = 2500. Last updated 16 March 2015. Last accessed 7 April 2015. |
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