RecruitingPhase 3NCT05255471

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

Olaparib Beyond Progression Compared to Platinum Chemotherapy After Secondary Cytoreductive Surgery in Recurrent Ovarian Cancer Patients. The Phase III Randomized, Open Label MITO 35b Study: a Project of the MITO-MANGO Groups.


Sponsor

National Cancer Institute, Naples

Enrollment

200 participants

Start Date

Jan 21, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether continuing a PARP inhibitor drug (olaparib) after secondary surgery is better than switching to platinum-based chemotherapy for women with recurrent ovarian, fallopian tube, or peritoneal cancer that has come back after prior PARP inhibitor maintenance therapy. **You may be eligible if...** - You are a woman aged 18 or older - You have high-grade serous or endometrioid ovarian, fallopian tube, or primary peritoneal cancer that has recurred after first-line PARP inhibitor maintenance - You have received only one prior line of platinum-based chemotherapy (without bevacizumab) - You had complete or partial tumor removal during secondary cytoreductive surgery - Your BRCA gene status has been tested (or you agree to be tested) - You are in good physical condition (ECOG 0 or 1) - Your life expectancy is at least 16 weeks **You may NOT be eligible if...** - You have received more than one prior line of platinum chemotherapy - You could not have your tumor fully removed at secondary surgery - Your prior olaparib use caused significant toxicity requiring permanent dose reduction - You have serious organ problems that would make treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOlaparib

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

DRUGChemotherapy 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


Locations(1)

IRCCS Istituto Nazionale Tumori di Napoli

Naples, Italy

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NCT05255471


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