Study identifier:D0818C00001
ClinicalTrials.gov identifier:NCT01844986
EudraCT identifier:2013-001551-13
CTIS identifier:N/A
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.
Newly diagnosed
Phase 3
No
Olaparib 300mg tablets
Female
450
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Aug 2024 by AstraZeneca
AstraZeneca
Gynecologic Oncology Group (GOG), Myriad Genetics - BRACAnalysis test for FDA Premarket Approval (PMA), Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Olaparib tablets p.o. 300mg twice daily Olaparib/placebo tablets p.o 300mg twice daily for up to 3 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 | 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. |
Placebo Comparator: Placebo tablets p.o. twice daily Olaparib/placebo tablets p.o 300mg twice daily for up to 3 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 | 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. |