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

PHASE3RecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

January 21, 2022

Primary Completion Date

January 21, 2028

Study Completion Date

January 21, 2028

Conditions
Ovarian Cancer
Interventions
DRUG

Olaparib

Olaparib 300 mg, film-coated tablets, twice daily PO, d1- 28 continuously

DRUG

Chemotherapy drug

"Platinum-based chemotherapy at the Investigator's choice among the following regimens:~* Carboplatin (AUC5) plus Pegylated Liposomal Doxorubicin (PLD) 30mg/m2 on day 1 every 28 days for a maximum of 8 cycles;~* Carboplatin (AUC4) plus Gemcitabine 1000mg/m2 on day 1, 8 every 21 days for a maximum of 8 cycles;~* Carboplatin (AUC5) plus Paclitaxel (175mg/m2) every 21days for a maximum of 8 cycles"

Trial Locations (1)

80131

RECRUITING

IRCCS Istituto Nazionale Tumori di Napoli, Naples

All Listed Sponsors
lead

National Cancer Institute, Naples

OTHER