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MITO 35a: Olaparib Maintenance Therapy in Newly Diagnosed BRCA Wild-type Advanced Ovarian, Fallopian Tube and Primitive Peritoneal Cancer | Clinical Trials | Clareo Health

UNKNOWNPHASE2

MITO 35a: Olaparib Maintenance Therapy in Newly Diagnosed BRCA Wild-type Advanced Ovarian, Fallopian Tube and Primitive Peritoneal Cancer

MITO 35a: A Multicenter, Prospective, Single Arm Trial of Olaparib Maintenance Therapy in Newly Diagnosed BRCA Wildtype Advanced Ovarian, Fallopian Tube and Primitive Peritoneal Cancer

NCT05233982•National Cancer Institute, Naples

View on ClinicalTrials.gov

Summary

This trial is a multicenter, prospective, phase II single arm, open-label trial in which patients with newly diagnosed advanced epithelial ovarian, primitive peritoneal, and fallopian tube cancer BRCA wild type, in partial or complete response to first line platinum-based chemotherapy, receive Olaparib maintenance therapy (300 mg, tablets formulation twice daily).

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Signed informed consent obtained prior to initiation of any study-specific procedures.
•2. Female aged≥18 years old on day of signing informed consent.
•3. Patients with histologically diagnosed advanced stage III-IV according International Federation of Gynaecology and Obstetrics (FIGO), high grade serous or endometrioid, epithelial ovarian cancer (including primary peritoneal or fallopian tube cancer).
•4. Patients with a complete or partial response to first line platinum-based treatment not including Bevacizumab.
•5. Documented absence of somatic and germline mutations of BRCA 1 /2.
•6. Patients must have a life expectancy ≥ 16 weeks.
•7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1, (See Appendix A).
•8. Availability of sufficient formalin-fixed paraffin-embedded (FFPE) tumor tissue from the primary surgery (chemotherapy - naïve patients) for translational analysis. A quality control analysis of samples will be performed before patient's enrollment.
•9. Patients must be enrolled within 8 weeks of the first day of the last dose of chemotherapy.
•10. Patients must be able to take oral medications.
+14 more criteria

Exclusion Criteria

•1. Patients have received Bevacizumab in concomitance with first line platinum-based therapy.
•2. Clear cell, mucinous and mixed mullerian tumors/carcinosarcoma, non-epithelial tumors or ovarian tumors with low malignant potential (ie. borderline tumors) are not allowed.
•3. Received chemotherapy within 14 days to first dose to study drug and / or persistent toxicities (\>Common Terminology Criteria for Adverse Event (CTCAE) version 5.0 grade 2) caused by previous cancer therapy, excluding alopecia, peripheral neuropathy and related effects of prior chemotherapy that are unlikely to be exacerbated by treatment with study drug.
•4. Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
•5. Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable).
•6. Breast feeding women.
•7. Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML.
•8. Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection \[Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, New York Heart Association (NYHA) grade II or greater congestive heart failure, uncontrolled hypertension, severe peripheral vascular disease, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric illness \]
•9. Patients with active second malignancy.
•10. Other malignancy unless curatively treated with no evidence of disease for ≥5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma.
+14 more criteria

Locations (5)

ONCOLOGIA MEDICA A.O. S. Giuseppe Moscati

Avellino, Italy

U.O.C. Oncologia Medica - Ospedale Senatore Antonio Perrino

Brindisi, Italy

IRCCS Istituto Nazionale Tumori di Napoli

Naples, Italy

Oncologia Medica 2 - Istituto Nazionale Tumori "Regina Elena"

Roma, Italy

ONCOLOGIA MEDICA 1 Istituto Nazionale Tumori Regina Elena - IRCCS - IFO

Rome, Italy

Key Dates

Start Date

December 9, 2021

Primary Completion Date

January 1, 2026

Completion Date

January 1, 2026

Last Updated

March 24, 2023

Enrollment

200

ESTIMATED participants

Conditions

Ovarian Cancer

Interventions

Olaparib Oral Product

DRUG

Contacts

Clorinda Schettino, MD

CONTACT

+3908159031791 c.schettino@istitutotumori.na.it

Sandro Pignata, MD

CONTACT

390815903637 s.pignata@istitutotumori.na.it

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 24, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

MITO 35a: Olaparib Maintenance Therapy in Newly Diagnosed BRCA Wild-type Advanced Ovarian, Fallopian Tube and Primitive Peritoneal Cancer

Inclusion Criteria

Exclusion Criteria

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