drugset / Trial / NCT05255471
MITO 35B: Olaparib Beyond Progression Compared to Platinum Chemotherapy After Secondary Cytoreductive Surgery in Recurrent Ovarian Cancer Patients.
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | 5 unknown | — |
| Subject | Doxorubicin | Other / unclassified | 30 mg/m2 | — |
| Subject | Olaparib | Small molecule | 300 mg | Oral |