MITO 35a: Olaparib Maintenance Therapy in Newly Diagnosed BRCA Wild-type Advanced Ovarian, Fallopian Tube and Primitive Peritoneal Cancer

Sponsor
National Cancer Institute, Naples
Study ID
NCT05233982
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Olaparib Oral Product — DRUG
    Olaparib Maintenace Treatment after first line platium based chemotherapy in BRCA wilde-type ovarian cancer patients

Study Details

This trial is a multicenter, prospective, phase II single arm, open-label trial in which patients with newly diagnosed advanced epithelial ovarian, primitive peritoneal, and fallopian tube cancer BRCA wild type, in partial or complete response to first line platinum-based chemotherapy, receive Olaparib maintenance therapy (300 mg, tablets formulation twice daily).

Key Dates

Start date
Dec 9, 2021
Status verified
Mar 2023
Primary completion
Jan 31, 2026
Completion
Jan 31, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: OLAPARIB

Primary Outcome Measure

Progression-free survival (PFS). [ Time Frame: From date of enrollment until the date of first documentated progression or date of death from any cause, whichever came first, assessed up to 60 months ]

Central Contacts

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