Study identifier:D9319C00001
ClinicalTrials.gov identifier:NCT04884360
EudraCT identifier:2020-005960-68
CTIS identifier:N/A
A Randomised, Double-blind, Placebo-controlled, Phase III Study of Olaparib Maintenance Monotherapy in Participants with BRCA Wild Type Advanced High Grade Serous or Endometrioid Ovarian Cancer Following Response to Standard First-line Platinum-based Chemotherapy (MONO-OLA1)
ovarian cancer
Phase 3
No
Olaparib
Female
367
Interventional
18 Years - n/a
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Aug 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Group A: Olaparib tablets 300 mg oral twice daily (n=238). Participants in Group A will receive olaparib tablets taken orally at a dose of 300 mg twice daily for up to 2 years or until objective radiological disease progression as per RECIST 1.1 as assessed by the investigator, whichever is earlier, and as long as in the investigator’s opinion they are benefiting from treatment and do not meet any other discontinuation criteria. | Drug: Olaparib Olaparib tablets 300 mg oral twice daily |
Placebo Comparator: Group B: Placebo tablets 300 mg oral twice daily (n=118) Participants in Group B will receive matching placebo tablets taken orally at a dose of 300 mg twice daily for up to 2 years or until objective radiological disease progression as per RECIST 1.1 as assessed by the investigator, whichever is earlier, and as long as in the investigator’s opinion they are benefiting from treatment and do not meet any other discontinuation criteria. | Other: Matching placebo Matching placebo tablets taken orally at a dose of 300 mg twice daily |