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

NCT05233982 | Unknown Phase 2

• 1 other identifier: EudraCT: 2021-000244-21
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 5

Brief 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).

Conditions

Ovarian Cancer

Keywords

olaparib; ovarian cancer; BRCA wilde-type

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS).

  PFS as defined by the Investigator using RECIST 1.1 as the time frame from enrollment to progression or death for any cause.

  From date of enrollment until the date of first documentated progression or date of death from any cause, whichever came first, assessed up to 60 months

Secondary Outcomes (3)

• Progression-free survival 2 (PFS2)

  From date of enrollment until the date of second documentated progression or date of death from any cause, whichever came first, assessed up to 60 months

• Overall Survival

  5 years

• Number of participants with treatment-related side effects graded according to Common Criteria for Adverse Events (CTCAE) version 5.0

  At baseline,at end of each cycle (each cycle is 28 days) until progression disease or treatment discontinuation (up to 24 months)]

Study Arms (1)

OLAPARIB

EXPERIMENTAL

Drug: Olaparib Oral Product

Interventions

Olaparib Oral Product DRUG

Olaparib Maintenace Treatment after first line platium based chemotherapy in BRCA wilde-type ovarian cancer patients

OLAPARIB

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent obtained prior to initiation of any study-specific procedures.
• Female aged≥18 years old on day of signing informed consent.
• 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).
• Patients with a complete or partial response to first line platinum-based treatment not including Bevacizumab.
• Documented absence of somatic and germline mutations of BRCA 1 /2.
• Patients must have a life expectancy ≥ 16 weeks.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1, (See Appendix A).
• 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.
• Patients must be enrolled within 8 weeks of the first day of the last dose of chemotherapy.
• Patients must be able to take oral medications.
• Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on Day 1 Cycle 1.
• Postmenopausal is defined as:
• Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments;
• Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post-menopausal range for women under 50;
• radiation-induced oophorectomy with last menses \>1 year ago;

You may not qualify if:

• Patients have received Bevacizumab in concomitance with first line platinum-based therapy.
• Clear cell, mucinous and mixed mullerian tumors/carcinosarcoma, non-epithelial tumors or ovarian tumors with low malignant potential (ie. borderline tumors) are not allowed.
• 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.
• Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
• Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable).
• Breast feeding women.
• Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML.
• Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection \[Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, New York Heart Association (NYHA) grade II or greater congestive heart failure, uncontrolled hypertension, severe peripheral vascular disease, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric illness \]
• Patients with active second malignancy.
• 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.
• Any prior treatment for ovarian cancer, other than first line platinum-based therapy, including any maintenance treatment between completion of the platinum regimen and initiation of study drug in this study.
• Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.
• Concurrent treatment with other investigational agents.
• Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
• Any positive test result for hepatitis B virus or hepatitis C virus indicating presence of virus, eg. Hepatitis B surface antigen (HBsAg, Australia antigen) positive, or Hepatitis C antibody (anti-HCV) positive (except if HCV-RNA negative).

Sponsors & Collaborators

• National Cancer Institute, Naples: lead

Study Sites (5)

ONCOLOGIA MEDICA A.O. S. Giuseppe Moscati

Avellino, Italy

NOT YET RECRUITING

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

Brindisi, Italy

NOT YET RECRUITING

IRCCS Istituto Nazionale Tumori di Napoli

Naples, 80131, Italy

RECRUITING

Oncologia Medica 2 - Istituto Nazionale Tumori "Regina Elena"

Roma, Italy

NOT YET RECRUITING

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

Rome, Italy

NOT YET RECRUITING

Related Links

• Sponsor web-site for study conduction

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Clorinda Schettino, MD

CONTACT

+3908159031791; c.schettino@istitutotumori.na.it

Sandro Pignata, MD

CONTACT

390815903637; s.pignata@istitutotumori.na.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: February 10, 2022
• Study Start: December 9, 2021
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

IT (5)