NCT01844986

Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.

A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian Cancer Following First Line Platinum Based Chemotherapy.

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Female
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

Olaparib Monotherapy in Patients with BRCA Mutated Ovarian Cancer following First Line Platinum Based Chemotherapy.

Detailed description

A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Patients with BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian Cancer following First Line Platinum Based Chemotherapy.

Conditions

• Newly Diagnosed
• Advanced Ovarian Cancer
• FIGO Stage III-IV
• BRCA Mutation
• Complete Response
• Partial Response
• First Line Platinum Chemotherapy

Interventions

Type	Name	Description
DRUG	Olaparib 300mg tablets	Olaparib/placebo tablets p.o 300mg 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 250mg and subsequently 200mg is permitted following confirmation of toxicity.

Timeline

• Start date: 2013-08-26
• Primary completion: 2018-05-17
• Completion: 2028-08-29
• First posted: 2013-05-03
• Last updated: 2025-12-10
• Results posted: 2019-07-09

Locations

177 sites across 15 countries: United States, Australia, Brazil, Canada, China, France, Israel, Italy, Japan, Netherlands, Poland, Russia, South Korea, Spain, United Kingdom