Ovarian CancerPhase 3MITO 35BNCT05255471
MITO 35B: Olaparib Beyond Progression Compared to Platinum Chemotherapy After Secondary Cytoreductive Surgery in Recurrent Ovarian Cancer Patients.
A Phase 3 study testing Olaparib and Chemotherapy drug in people with Ovarian Cancer, run by National Cancer Institute, Naples at 1 site in Italy.
Trial summary
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. 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 and Chemotherapy drug
- 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
- 21 Jan 2022to 21 Jan 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
None listed.
Who cannot join
- Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease, and/or active, uncontrolled infection. that may interfere with planned treatment, affect patient compliance or place the patient at high risk from treatment related complications [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 unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication;
- Patients eligible for a platinum based chemotherapy doublet and bevacizumab;
- Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatments; prior palliative radiation must have been completed at least 7 days prior to the start of study drugs, and patients must have recovered from any acute adverse effects prior to the start of study treatment;
- Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of major surgery;
- Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT);
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- Breast feeding women;
- 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;
- 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) and Stage 1, grade 1 endometrial carcinoma;
- Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable) except for transfusion done during surgery;
- Persistent toxicities >grade 2 according Common Terminology Criteria for Adverse (CTCAE) version 5.0 caused by previous cancer therapy, excluding alopecia;
- Resting ECG indicating uncontrolled, potentially irreversible 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;
- 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 myelodysplastic syndrome (MSD)/acute myeloid leukaemia (AML) or with features suggestive of MDS/AML;
- Immunocompromised patients, e.g., patients who are known to be serologically positive (HIV 1-2 antibody positivity) for human immunodeficiency virus (HIV);
- Patients with a known hypersensitivity to olaparib or any of the excipients of the product;
- Patients that, at the Investigator's opinion, are not eligible according to ESMO (European society for Medical Oncology) guidelines for a re-treatment with a platinum containing therapy (i.e. patient has experienced a major adverse reaction to platinum salts during first line therapy);
- Patients with known active hepatitis (i.e. Hepatitis B or C)
- Active hepatitis B virus (HBV) is defined by a known positive HBV surface antigen (HBsAg) result. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody and absence of HBsAg) are eligible.
- Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- Participation in another clinical study with an investigational product during the last 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto Nazionale Tumori di Napoli
Naples, 80131
Sandro Pignata, MD, PhD, 0815903637, s.pignata@istitutotumori.na.it
Sandro Pignata, MD, PhD
About this study
Official title: Olaparib Beyond Progression Compared to Platinum Chemotherapy After Secondary Cytoreductive Surgery in Recurrent Ovarian Cancer Patients. The Phase III Randomized, Open Label MITO 35b Study: a Project of the MITO-MANGO Groups.
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
- Ovarian Cancer
- Being tested
- Olaparib, Chemotherapy drug
- Keywords
- Recurrent ovarian cancer, Olaparib, Chemotherapy, Secondary Cytoreductive Surgery
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlaparibDrug
Olaparib 300 mg, film-coated tablets, twice daily PO, d1- 28 continuously
Chemotherapy drugDrug
Platinum-based chemotherapy at the Investigator's choice among the following regimens:
- Carboplatin (AUC5) plus Pegylated Liposomal Doxorubicin (PLD) 30mg/m2 on day 1 every 28 days for a maximum of 8 cycles;
- Carboplatin (AUC4) plus Gemcitabine 1000mg/m2 on day 1, 8 every 21 days for a maximum of 8 cycles;
- Carboplatin (AUC5) plus Paclitaxel (175mg/m2) every 21days for a maximum of 8 cycles
| Study group | Role | What they receive |
|---|---|---|
| Olaparib | Experimental | Not described Receives: Drug: Olaparib |
| Chemotherapy | Active comparator | Not described Receives: Drug: Chemotherapy drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
PFS as defined by the Investigator using RECIST 1.1, as the time frame from randomization to progression or death for any cause,whichever comes first
Measured: until progression disease ( up to 5 years )
Progession free survival 2 (PFS2)
PFS as defined by the Investigator using RECIST 1.1, as the time frame from randomization to second progression or death for any cause
Measured: until progression disease ( up to 5 years )
Secondary outcomes (5)
Overall survival
OS as defined by the Investigator as the time from randomization to death for any cause, whichever comes first.
Measured: 5 years
Determination of changes in quality of life
EORTC QLQ-C30, a quality questionnaire, composed by 30 items graded from 1 (not at all) to 4 (very much).
Measured: At baseline, at Day 1 of each Cycle (during treatment) until 6 months, then at 9 and 12 months (up to 12 months).Each cycle is 28 days
Determination of changes in patient-reported outcome (PRO) symptomatic toxicities
PRO-CTCAE questionnaire, composed by 78 items graded from 1 (not at all) to 5 (very much).
Measured: At baseline, at Day 1 of each Cycle (during treatment) until 6 months, then at 9 and 12 months (up to 12 months. Each cycle is 28 days
Changes in patient-reported outcome (PRO) of cancer-related financial toxicity
The PROFFITquestionnaire consists of 16 items,graded from 1 (not at all) to 4 (very much).
Measured: t baseline, at day 1 of each Cycle (during treatment) until 6 months, then at 9 and 12 months (up to 12 months). Each cycle is 28 days
Number of participants with treatment-related side effects
Number of participants with treatment-related side effects
Number of participants with treatment-related side effects graded according to Common Criteria for Adverse Events (CTCAE) version 5.0
Measured: At baseline, day 1 of each cycle until progression disease (up to 5 years)].Each cycle is 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start21 Jan 2022
- Primary completion21 Jan 2028 (estimated)
- Study completion21 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255471
- Sponsor's protocol ID
- MITO35B/EudraCT:2021-000245-41
- Acronym
- MITO 35B
- Status last verified
- Mar 2023
- First submitted
- 1 Feb 2022
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schettino C, Musacchio L, Bartoletti M, Chiodini P, Arenare L, Baldassarre G, Califano D, Capoluongo E, Costi MP, D'Incalci M, Marchini S, Mezzanzanica D, Normanno N, Scala S, Greggi S, Perrone F, Pignata S. Olaparib beyond progression compared with platinum chemotherapy after secondary cytoreductive surgery in patients with recurrent ovarian cancer: phase III randomized, open-label MITO 35b study, a project of the MITO-MANGO groups. Int J Gynecol Cancer. 2022 Jun 6;32(6):799-803. doi: 10.1136/ijgc-2022-003435.
PubMed 35318277
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olaparib Beyond Progression Compared to Platinum Chemotherapy After Secondary Cytoreductive Surgery in Recurrent Ovarian Cancer Patients. The Phase III Randomized, Open Label MITO 35b Study: a Project of the MITO-MANGO Groups.
- ClinicalTrials.gov ID
- NCT05255471
- Acronym / sponsor ID
- MITO 35B / MITO35B/EudraCT:2021-000245-41
- Conditions
- Ovarian Cancer
- Keywords
- Recurrent ovarian cancer, Olaparib, Chemotherapy, Secondary Cytoreductive Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 21 Jan 2028 (estimated)
- Study completion
- 21 Jan 2028 (estimated)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olaparib | Experimental | Drug: Olaparib |
| Chemotherapy | Active comparator | Drug: Chemotherapy drug |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (22 listed)
- Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease, and/or active, uncontrolled infection. that may interfere with planned treatment, affect patient compliance or place the patient at high risk from treatment related complications [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 unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication;
- Patients eligible for a platinum based chemotherapy doublet and bevacizumab;
- Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatments; prior palliative radiation must have been completed at least 7 days prior to the start of study drugs, and patients must have recovered from any acute adverse effects prior to the start of study treatment;
- Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of major surgery;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OlaparibOlaparib 300 mg, film-coated tablets, twice daily PO, d1- 28 continuously | Drug | Olaparib |
| Chemotherapy drugPlatinum-based chemotherapy at the Investigator's choice among the following regimens: * Carboplatin (AUC5) plus Pegylated Liposomal Doxorubicin (PLD) 30mg/m2 on day 1 every 28 days for a maximum of 8 cycles; * Carboplatin (AUC4) plus Gemcitabine 1000mg/m2 on day 1, 8 every 21 days for a maximum of 8 cycles; * Carboplatin (AUC5) plus Paclitaxel (175mg/m2) every 21days for a maximum of 8 cycles | Drug | Chemotherapy |
Primary outcome
Progression-free survival (PFS)
Time frame: until progression disease ( up to 5 years )
PFS as defined by the Investigator using RECIST 1.1, as the time frame from randomization to progression or death for any cause,whichever comes first
Progession free survival 2 (PFS2)
Time frame: until progression disease ( up to 5 years )
PFS as defined by the Investigator using RECIST 1.1, as the time frame from randomization to second progression or death for any cause
5 secondary outcomes
Overall survival
Time frame: 5 years
Determination of changes in quality of life
Time frame: At baseline, at Day 1 of each Cycle (during treatment) until 6 months, then at 9 and 12 months (up to 12 months).Each cycle is 28 days
Determination of changes in patient-reported outcome (PRO) symptomatic toxicities
Time frame: At baseline, at Day 1 of each Cycle (during treatment) until 6 months, then at 9 and 12 months (up to 12 months. Each cycle is 28 days
Changes in patient-reported outcome (PRO) of cancer-related financial toxicity
Time frame: t baseline, at day 1 of each Cycle (during treatment) until 6 months, then at 9 and 12 months (up to 12 months). Each cycle is 28 days
Number of participants with treatment-related side effects
Time frame: At baseline, day 1 of each cycle until progression disease (up to 5 years)].Each cycle is 28 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Derived from this study: PubMed 35318277Schettino C, Musacchio L, Bartoletti M, Chiodini P, Arenare L, Baldassarre G, Califano D, Capoluongo E, Costi MP, D'Incalci M, Marchini S, Mezzanzanica D, Normanno N, Scala S, Greggi S, Perrone F, Pignata S. Olaparib beyond progression compared with platinum chemotherapy after secondary cytoreductive surgery in patients with recurrent ovarian cancer: phase III randomized, open-label MITO 35b study, a project of the MITO-MANGO groups. Int J Gynecol Cancer. 2022 Jun 6;32(6):799-803. doi: 10.1136/ijgc-2022-003435.
- Sponsor web-site for study conductionLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Olaparib and Chemotherapy drug in people with 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 0 inclusion and 22 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: looking for participants now, 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clorinda Schettino, MD (003908159031791, 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: until progression disease ( up to 5 years )). The study lists 2 primary outcomes in all. 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 NCT05255471, which also lists 1 linked publication.
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; AzTrials last refreshed its copy on 6 Nov 2026.