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Ovarian CancerPhase 2MITO 35aNCT05233982

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

A Phase 2 study testing Olaparib Oral Product in people with Ovarian Cancer, run by National Cancer Institute, Naples at 5 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Olaparib Oral Product
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
5 sitesItaly
Study dates
9 Dec 2021to Jan 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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;
  • chemotherapy-induced menopause with >1 year interval since last menses;
  • surgical sterilisation (bilateral oophorectomy or hysterectomy).
  • Women Women of childbearing potential and their partners, who are sexually active, must agree to the use of one highly effective forms of contraception and their partners must use a male condom (as described in Appendix D). This should be started from the signing of the informed consent and continue throughout the period of taking study treatment and for at least 1 month after last dose of study drug
  • Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:
  • Haemoglobin ≥ 10.0 g/dL with no blood transfusion in the past 28 days; Absolute neutrophil count (ANC) ≥ 1.5 x 109/L; Platelet count ≥ 100 x 109/L; Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case they must be ≤ 5x ULN
  • Patients must have creatinine clearance estimated of ≥51 mL/min using the Cockcroft-Gault equation or based on a 24-hour urine test:
  • Estimated creatinine clearance = (140-age [years]) x weight (kg) (x F) a
  • serum creatinine (mg/dL) x 72 a where F=0.85 for females
  • Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.

Who cannot join

  • 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.
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  • 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).
  • Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV).
  • Patients with symptomatic uncontrolled brain metastases. A TC/RMN scan of brain is required at baseline. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment.
  • Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.
  • Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (eg., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation < 470 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome.
  • Evidence of any other medical conditions, physical examination or laboratory findings that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment related complications;
  • Concomitant use of known strong CYP3A inhibitors (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks.
  • Concomitant use of known strong (e.g. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.
  • Patients with a known hypersensitivity to olaparib or any of the excipients of the product;
  • Presence of any other condition that may increase the risk associated with study participation or may interfere with the interpretation of study results, and in the opinion of the investigator, would make the

Trial locations and contacts

5 sites in 1 country.

Clorinda Schettino, MD contact

+3908159031791

c.schettino@istitutotumori.na.it

Sandro Pignata, MD contact

390815903637

s.pignata@istitutotumori.na.it

5 sites in 1 country

Italy5 sites, 5 recruiting

  • ONCOLOGIA MEDICA A.O. S. Giuseppe Moscati

    Avellino

    Emanuela Rossi, MD, 0825203945, emanuelarossi41@libero.it

    Emanuela Rossi, MD

    Not yet recruiting

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

    Brindisi

    Saverio Cinieri, MD, 0831537217, saverio.cinieri@asl.brindisi.it

    Saverio Cinieri, MD

    Not yet recruiting

  • IRCCS Istituto Nazionale Tumori di Napoli

    Naples, 80131

    Sandro Pignata, MD, PhD, 0815903637, s.pignata@istitutotumori.na.it

    Sandro Pignata, MD, PhD

    Recruiting

  • Oncologia Medica 2 - Istituto Nazionale Tumori "Regina Elena"

    Roma

    Domenico Sergi, MD, 0652665585, domenico.sergi@ifo.gov.it

    Domenico Sergi, MD

    Not yet recruiting

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

    Rome

    Antonella Savarese, MD, 3393763168, antonella.savarese@ifo.gov

    Antonella Savarese, MD

    Not yet recruiting

Other trials in Italy

About this study

Official title: 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

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
Being tested
Olaparib Oral Product
Keywords
olaparib, ovarian cancer, BRCA wilde-type
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Olaparib Oral ProductDrug

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

Study groups in NCT05233982
Study groupRoleWhat they receive
OLAPARIBExperimentalNot described
Receives: Drug: Olaparib Oral Product

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. Progression-free survival 2 (PFS2)

    PFS2 as defined by the Investigator using RECIST 1.1, as the time frame from enrollment to the second progression or death for any cause after subsequent treatment.

    Measured: 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

  2. Overall Survival

    OS is defined as the time elapsed from randomization to death due to any cause

    Measured: 5 years

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

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2022
  2. Study start9 Dec 2021
  3. Primary completionJan 2026 (estimated)
  4. Study completionJan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05233982
Sponsor's protocol ID
EudraCT: 2021-000244-21
Acronym
MITO 35a
Status last verified
Mar 2023
First submitted
18 Jan 2022
Last updated
24 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Olaparib Oral Product in people with Ovarian Cancer, run by National Cancer Institute, Naples at 5 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Clorinda Schettino, MD (+3908159031791, c.schettino@istitutotumori.na.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS). (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05233982.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.

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