drugset / Trial / NCT05255471

MITO 35B: Olaparib Beyond Progression Compared to Platinum Chemotherapy After Secondary Cytoreductive Surgery in Recurrent Ovarian Cancer Patients.

NCT05255471

Phase 3 Recruiting 200 enrolled National Cancer Institute, Naples
RandomizedParallel-groupOpen-labelTreatment

Summary

MITO 35b is designed as randomized, open label, phase III trial that aims to assess the efficacy of olaparib maintenance beyond progression compered to standard platinum-based chemotherapy after secondary cytoreductive surgery. The target population of this study are ovarian cancer patients who experience a disease recurrence or progression to a first line maintenance therapy with PARPi; at progression patients must have received a secondary cytoreduction according to clinical practice.

Timeline

Start
2022-01-21
Primary completion
2028-01-21
Completion
2028-01-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 5 unknown
Subject Doxorubicin Other / unclassified 30 mg/m2
Subject Olaparib Small molecule 300 mg Oral

Indications