D9319C00001- 1L OC Mono Global RCT

Sponsor
AstraZeneca
Study ID
NCT04884360
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Olaparib — DRUG
    Olaparib tablets 300 mg oral twice daily
  • Matching placebo — OTHER
    Matching placebo tablets taken orally at a dose of 300 mg twice daily

Study Details

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.

Key Dates

Start date
May 31, 2021
Status verified
Feb 2026
Primary completion
Jul 27, 2026
Completion
Jul 27, 2027

Study Design

Enrollment
366 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Superiority of olaparib as maintenance treatment relative to placebo by assessment of PFS in participants with Stage III/IV ovarian cancer with a BRCAwt HRD positive tumour and a CR/PR following standard 1st line platinum based chemotherapy treatment. [ Time Frame: Approximately 3 years ]

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