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

NCT05255471 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-03-24

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • National Cancer Institute, Naples

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05255471 on ClinicalTrials.gov