Actively Recruiting
MITO 35B: Olaparib Beyond Progression Compared to Platinum Chemotherapy After Secondary Cytoreductive Surgery in Recurrent Ovarian Cancer Patients.
Led by National Cancer Institute, Naples · Updated on 2023-03-24
200
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
MITO 35B: Olaparib Beyond Progression Compared to Platinum Chemotherapy After Secondary Cytoreductive Surgery in Recurrent Ovarian Cancer Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures
- Female aged 18 years or older at consent
- Diagnosis of high-grade serous or endometrioid ovarian, fallopian tube, or primary peritoneal cancer recurring or progressing after first-line PARPi maintenance
- Received only one prior platinum-containing chemotherapy regimen without bevacizumab
- First-line PARPi maintenance therapy for at least 6 months; if prior PARPi was olaparib, no significant toxicity or dose reduction required
- Disease relapse after completing up to 24 months of maintenance therapy also eligible
- Underwent secondary cytoreductive surgery with complete resection or removal of progressive lesions
- Documented BRCA1/2 status or agree to testing before enrollment
- Life expectancy of at least 16 weeks
- Begin study treatment within 3 to 8 weeks after secondary surgery
- ECOG performance status 0 or 1
- Provide archival tumor samples from primary and secondary surgeries for analysis
- Able to take oral medications
- Normal organ and bone marrow function within 28 days prior to treatment, including specified blood counts and liver and kidney function
- Postmenopausal or non-childbearing status confirmed by tests or medical history
- Women of childbearing potential and partners agree to use effective contraception during and for 1 month after treatment
- Willing and able to follow study visits, treatments, tests, and procedures
You will not qualify if you...
- Serious uncontrolled medical conditions or infections that increase risk or interfere with treatment
- Inability to swallow oral medication or gastrointestinal issues affecting absorption
- Eligibility for platinum chemotherapy doublet plus bevacizumab
- Recent systemic chemotherapy or radiotherapy within 3 weeks prior to study treatment (except palliative)
- Major surgery within 2 weeks before starting treatment without full recovery
- Previous allogenic bone marrow or double umbilical cord blood transplant
- Breastfeeding women
- Uncontrolled symptomatic brain metastases; stable brain disease and steroid use allowed if started 4 weeks prior
- Other malignancies treated curatively without disease for 5+ years, with some exceptions
- Whole blood transfusions in last 120 days except during surgery
- Persistent grade >2 toxicities from prior cancer therapy, except hair loss
- Uncontrolled or potentially irreversible cardiac conditions or abnormal ECG
- Use of strong or moderate CYP3A inhibitors or inducers without required washout periods
- Myelodysplastic syndrome or acute myeloid leukemia or suggestive features
- Immunocompromised patients including HIV positive
- Known hypersensitivity to olaparib or its ingredients
- Not eligible for platinum retreatment per guidelines due to prior adverse reactions
- Active hepatitis B or C infection
- Participation in another investigational study within last 3 months
AI-Screening
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Trial Site Locations
Total: 1 location
1
IRCCS Istituto Nazionale Tumori di Napoli
Naples, Italy, 80131
Actively Recruiting
Research Team
C
Clorinda Schettino, MD
CONTACT
S
Sandro Pignata, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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