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

Sponsor
National Cancer Institute, Naples
Study ID
NCT05255471
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Olaparib — DRUG
    Olaparib 300 mg, film-coated tablets, twice daily PO, d1- 28 continuously
  • Chemotherapy drug — 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

Study Details

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.

Key Dates

Start date
Jan 21, 2022
Status verified
Mar 2023
Primary completion
Jan 21, 2028
Completion
Jan 21, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Olaparib
  • Active Comparator: Chemotherapy

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: until progression disease ( up to 5 years ) ]

Central Contacts

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