Trial intelligence / Profile preview

MITO 35b: Olaparib vs Chemotherapy in Recurrent Ovarian Cancer

NCT05255471Phase 3

Key facts

Status: Recruiting
Start: Jan 2022
Primary completion: Jan 2028
Countries: 1
Sponsor: National Cancer Institute
Modality: Small Molecules

Drugs: olaparib
Conditions: ovarian cancer

Overview

Phase 3, randomised, open-label trial of olaparib in ovarian cancer (2 arms), sponsored by National Cancer Institute. Primary endpoints: Progression-Free Survival up to 5 years and Progression-Free Survival 2 up to 5 years. Started Jan 2022; status: recruiting.

Design

2 arms

Study design: RandomizedOpen-label

Olaparib
Olaparib 300 mg BID maintenance
Chemotherapy
Platinum-based chemotherapy (Carboplatin + PLD/Gemcitabine/Paclitaxel)

Who it enrols

Patients with recurrent high-grade serous or endometrioid ovarian cancer who progressed on first-line PARPi maintenance, underwent secondary cytoreductive surgery, and have documented BRCA1/2 status.

Endpoints

Primary

Progression-Free Survivalup to 5 years
Progression-Free Survival 2up to 5 years

Secondary

Overall Survival5 years
Quality of Lifeup to 12 months
Patient-Reported Outcome Symptomatic Toxicitiesup to 12 months
Cancer-Related Financial Toxicityup to 12 months
Treatment-Related Side Effectsup to 5 years

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