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BRCA Wild Type Platinum Sensitive Recurrent Ovarian CancerPhase 2MITO 31NCT04091204

Olaparib in Patients With Recurrent Ovarian Cancer Wild Type for Germline and Somatic BRCA 1 and 2 Genes: The MITO 31 Translational Study

A Phase 2 study testing Olaparib tablets in people with BRCA Wild Type Platinum Sensitive Recurrent Ovarian Cancer, run by National Cancer Institute, Naples at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The aim of the study is to explore a prognostic clinical and molecular biomarker profile in a population of BRCA wild-type recurrent high-grade ovarian cancer patients treated with olaparib as maintenance after response to a platinum based therapy as platinum sensitive recurrence treatment. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Olaparib tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteItaly
Study dates
4 Jul 2019to 1 Sep 2023
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

  • Patients must be ≥ 18 years of age
  • Female patients with histologically diagnosed relapsed high grade ovarian cancer (including primary peritoneal and /or fallopian tube cancer)
  • Documented absence of somatic and germline mutations of BRCA1 or BRCA2 genes, that is predicted to be deleterious or suspected deleterious
  • ECOG Performance Status of 0-2
  • Patients must have a life expectancy of at least 16 weeks
  • Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient's awareness and willingness to comply with the study requirements
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  • Availability of tumor and blood samples for molecular analyses
  • Patients who have received at least 2 previous line of platinum containing therapy prior to randomization
  • For the penultimate chemotherapy course prior to enrolment on the study:
  • Patient defined as platinum sensitive after this treatment, defined as having disease progression greater than 6 months after completion of their last dose of platinum chemotherapy
  • For the last chemotherapy course immediately prior to randomization on the study:
  • Patients must be, in the opinion of the investigator, in radiologic response (partial or complete response) according to RECIST 1.1 criteria, or may have no evidence of disease (if optimal cytoreductive surgery was conducted prior to chemotherapy), and no evidence of a rising CA-125 compared to nadir value, following completion of this chemotherapy course i. Patient must have received, at least 4 cycles of a platinum based chemotherapy regimen (e.g. carboplatin or cisplatin per standard clinical practice) j. Patients must be enrolled within 8 weeks of their last dose of chemotherapy k. Maintenance treatment, including bevacizumab, is allowed at the end of the penultimate platinum regimen l. 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 m. Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:
  • Hemoglobin ≥ 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 using the Cockcroft-Gault equation of ≥ 51 mL/min:
  • 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 and F=1 for males

Who cannot join

  • History or evidence of synchronous primary endometrial carcinoma, unless all of the following criteria related to the endometrial carcinoma are met:
  • stage ≤ IA
  • no more than superficial myometrial invasion
  • no lymph vascular invasion
  • not poorly differentiated (grade 3 or papillary serous or clear cell carcinoma)
  • Other malignancy within the last 5 years, except for adequately treated non melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinomna in situ (DCIS), stage 1, grade 1 endometrial carcinoma, or other solid tumours including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for > 5years
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  • Resting ECG with QTc > 470 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome
  • Participation in another clinical study with an investigational product during the chemotherapy course immediately prior to randomization
  • Patients receiving any systemic radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment
  • 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
  • Persistent toxicities [>Common Terminology Criteria for Adverse Event (CTCAE) grade 2)] caused by previous cancer therapy, excluding alopecia
  • Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML
  • Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. 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
  • Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery
  • Patients considered at 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, 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 disorder that prohibits obtaining informed consent
  • Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication
  • Breast-feeding women
  • Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV)
  • Patients with a known hypersensitivity to olaparib or any of the excipients of the product
  • Patients with known active hepatitis (i.e. Hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids
  • 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)
  • Any previous treatment with PARP inhibitor, including olaparib
  • Involvement in the planning and/ or conduct of the study
  • Previous enrolment in the present study

Trial locations and contacts

1 site in 1 country.

Sandro Pignata, MD, PhD contact

+39 081 590 3637

s.pignata@istitutotumori.na.it

Clorinda Schettino, MD contact

+39 081 590 1791

c.schettino@istitutotumori.na.it

Italy1 site, 1 recruiting

  • Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico

    Naples, 80131

    Sandro Pignata, MD, PhD, +39 081 590 3637 ext. +390815903637, s.pignata@istitutotumori.na.it

    Clorinda Schettino, MD, +39 081 590 1791 ext. +390815903637, c.schettino@istitutotumori.na.it

    Recruiting

Other trials in Italy

About this study

Official title: A Phase II Trial of Olaparib in Patients With Recurrent Ovarian Cancer Wild Type for Germline and Somatic BRCA 1 and 2 Genes: The MITO 31 Translational Study

The aim of the study is to explore a prognostic clinical and molecular biomarker profile in a population of BRCA wild-type recurrent high-grade ovarian cancer patients treated with olaparib as maintenance after response to a platinum based therapy as platinum sensitive recurrence treatment.

Read the detailed description

This is a single arm, open-label Phase 2 study designed to evaluate the effect of maintenance olaparib treatment after response to platinum-based chemotherapy in patients with BRCA wild type platinum sensitive recurrent ovarian cancer. The goal is to identify a clinical and molecular profile able to select a group of patients, treated with olaparib as maintenance, with a favorable prognosis.

Being tested
Olaparib tablets
Keywords
wild-type BRCA 1 and 2, platinum sensitive, recurrent ovarian cancer, olaparib, maintenance treatment
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 tabletsDrug

    Olaparib is given orally at the dose of 300 mg bid continually as maintenance therapy after a platinum based chemotherapy

Study groups in NCT04091204
Study groupRoleWhat they receive
OlaparibExperimentalOlaparib is given orally at the dose of 300 mg bid continually as maintenance therapy after a platinum based chemotherapy
Receives: Drug: Olaparib tablets

What is being measured

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

  1. Progression Free Survival

    as determined by investigator

    Measured: up to 24 months

Secondary outcomes (4)

  1. Overall Survival

    as determined by investigator

    Measured: up to 36 months

  2. Progression Free Survival 2

    as determined by investigator, after the subsequent line of treatment

    Measured: up to 36 months

  3. Worst grade toxicity per patient

    graded according to Common Terminology Criteria for Adverse Event (CTCAE) version 5.0

    Measured: evaluated at each cycle every 28 days (during maintenance therapy), up to 30 days after cessation of olaparib

  4. Response Rate

    according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: 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 posted16 Sep 2019
  2. Study start4 Jul 2019
  3. Primary completion1 Sep 2023 (estimated)
  4. Study completion1 Sep 2023 (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
Model description
This is a single arm, multicentre, open-label Phase 2 study
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04091204
Sponsor's protocol ID
MITO 31
Other IDs
2018-000617-20, 2018
Acronym
MITO 31
Status last verified
Mar 2023
First submitted
9 Sep 2019
Last updated
24 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Olaparib tablets in people with BRCA Wild Type Platinum Sensitive Recurrent Ovarian Cancer, run by National Cancer Institute, Naples at 1 site 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 19 inclusion and 27 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 1 site 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 Sandro Pignata, MD, PhD (+39 081 590 3637, s.pignata@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 (time frame: up to 24 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 NCT04091204.

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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