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
366
Interventional
18 Years - n/a
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Oct 2024 by AstraZeneca
AstraZeneca
-
This is a Phase III, randomised, double-blind, placebo-controlled, multicentre, international study assessing the efficacy and safety of maintenance olaparib compared with placebo in BRCAwt participants with Stage III to IV high grade serous or endometroid ovarian cancer (including fallopian tube cancer or primary peritoneal cancer) who are in complete or partial response following treatment with standard first-line platinum-based chemotherapy.
Location
Location
Kryvyi Rih, Ukraine, 50048
Location
Kyiv, Ukraine, 03022
Location
Kyiv, Ukraine, 04050
Location
Kharkiv, Ukraine, 61103
Location
Chernihiv, Ukraine, 14029
Location
Ivano-Frankivsk, Ukraine, 76018
Location
Samsun, Turkey, 55139
Location
Karsiyaka, Turkey, 35575
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 |
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