NCT05255471RecruitingPhase 3
MITO 35B: Olaparib Beyond Progression Compared to Platinum Chemotherapy After Secondary Cytoreductive Surgery in Recurrent Ovarian Cancer Patients.
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.
Source: ClinicalTrials.gov · Last updated 24 Mar 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 1 Feb 2022
- Start date
- 21 Jan 2022
- Primary completion date
- 21 Jan 2028
- Lead sponsor
- National Cancer Institute, Naples
- Diseases
- Ovarian cancer
- NCT number
- NCT05255471
- EU CT number
- 2024-516842-21-00
- EudraCT number
- 2021-000245-41
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 200
- From 21 Jan 2022 to the primary completion date, 21 Jan 2028
- 40 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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);
- 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;
- 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 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);
- Participation in another clinical study with an investigational product during the last 3 months
Other illness
- 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;
- Persistent toxicities \>grade 2 according Common Terminology Criteria for Adverse (CTCAE) version 5.0 caused by previous cancer therapy, excluding alopecia;
- 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 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.
Lab values
- 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;
- 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;
Other
- Breast feeding women;
Criteria the registry did not label
- Signed informed consent prior to any study specific procedures;
- Female, age ≥ 18 years at time of signing informed consent
- Patients with high-grade serous or endometroid ovarian, fallopian tube, or primary peritoneal cancer recurrent or progressive after first line PARPi maintenance are allowed;
- Patients must have received only one previous line of a platinum containing regimen not containing bevacizumab;
- Patient must have received a first-line maintenance therapy with a PARPi for at least 6 months, if the prior PARPi used was olaparib then patients must have received treatment without significant toxicity or the need for a permanent dose reduction.Patients who experience disease relapse after the end of the 24 months maintenance therapy are eligible;
- Patients must have undergone secondary cytoreductive surgery. The cytoreduction must result in complete resection (absence of macroscopic residual tumor) or at least resection of the progressive lesion(s) occurring during maintenance;
- Documented BRCA1/2 status. Both mutated and wild type patients are eligible. Patient with unknown status of BRCA genes agrees to undergo analysis of their germline and somatic BRCA status (testing must be completed prior to enrolment in the study);
- Patients must have a life expectancy ≥ 16 weeks;
- Patients must start the experimental treatments in the current study within 3 to 8 weeks from second surgery;
- ECOG performance status 0 to 1;
- Patient must provide archival tumor samples formalin fixed, paraffin embedded (FFPE) from both the primary and secondary surgeries for paired analysis. A quality control analysis of samples will be performed before patient's randomization;
- Patient must be able to take oral medications;
- 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 serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) and Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤ 2.5 x ULN for the institution (or ≤ 5x ULN if liver metastases are present)
- 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.
- 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:
- 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 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, during the treatment and for at least 1 months after last dose of olaparib.For chemotherapy drugs, please refer to fertility section of corresponding Summary of Product Characteristics (SCP);
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures;
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (40)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ente Ecclesiastico ospedale generale Regionale Miulli Coordinator of this site? Confirm its status | Acquaviva delle Fonti | Italy | Recruiting |
| Azienda Sanitaria Locale Al Di Alessandria Coordinator of this site? Confirm its status | Alexandria | Italy | Recruiting |
| Centro di Riferimento Oncologico di Aviano Coordinator of this site? Confirm its status | Aviano | Italy | Recruiting |
| University Hospital Consorziale Policlinico Coordinator of this site? Confirm its status | Bari | Italy | Recruiting |
| A. O. U. Policlinico Sant'Orsola Malpighi Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| Istituto di Candiolo Fondazione del Piemonte per l'oncologia IRCCS Coordinator of this site? Confirm its status | Candiolo | Italy | Recruiting |
| Azienda Ospedaliera per l Emergenza Cannizzaro Coordinator of this site? Confirm its status | Catania | Italy | Recruiting |
| PO Garibaldi-Nesima, ARNAS Garibaldi Coordinator of this site? Confirm its status | Catania | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Mater Domini Coordinator of this site? Confirm its status | Catanzaro | Italy | Recruiting |
| Azienda Ospedaliera Santa Croce E Carle Coordinator of this site? Confirm its status | Cuneo | Italy | Recruiting |
| Azienda Unita Sanitaria Locale Della Romagna Coordinator of this site? Confirm its status | Faenza | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| Ospedale Misericordia - Grosseto - Azienda Usl Toscana sud est Coordinator of this site? Confirm its status | Grosseto | Italy | Recruiting |
| Ospedale Vito Fazzi Lecce Coordinator of this site? Confirm its status | Lecce | Italy | Recruiting |
| Alessandro Manzoni Hospital Coordinator of this site? Confirm its status | Lecco | Italy | Recruiting |
| Azienda Unita Sanitaria Locale Della Romagna Coordinator of this site? Confirm its status | Lugo | Italy | Recruiting |
| Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l Coordinator of this site? Confirm its status | Meldola | Italy | Recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Humanitas Mirasole S.p.A. Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| IRCCS Istituto Nazionale Tumori Fondazione Pascale Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Federico II Di Napoli Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Maggiore della Carità Coordinator of this site? Confirm its status | Novara | Italy | Recruiting |
| Istituto Oncologico Veneto Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
| ARNAS Civico Di Cristina Benfratelli Coordinator of this site? Confirm its status | Palermo | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Parma Coordinator of this site? Confirm its status | Parma | Italy | Recruiting |
| Ospedale Santa Maria Della Misericordia - Azienda Ospedaliera di Perugia Coordinator of this site? Confirm its status | Perugia | Italy | Recruiting |
| Ospedale Santa Chiara Coordinator of this site? Confirm its status | Pisa | Italy | Recruiting |
| Azienda Unità Sanitaria Locale della Romagna Coordinator of this site? Confirm its status | Ravenna | Italy | Recruiting |
| Azienda USL IRCCS di Reggio Emilia Coordinator of this site? Confirm its status | Reggio Emilia | Italy | Recruiting |
| ASST Rhodense/Presidio Ospedaliero di Rho Coordinator of this site? Confirm its status | Rho | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Ospedale S.G. Moscati Coordinator of this site? Confirm its status | Statte | Italy | Recruiting |
| Azienda Provinciale Per I Servizi Sanitari - Ospedale Civile Santa Chiara Coordinator of this site? Confirm its status | Trento | Italy | Recruiting |
| Azienda Unita' Locale Socio Sanitaria N. 2 Marca Trevigiana Coordinator of this site? Confirm its status | Treviso | Italy | Recruiting |
| Azienda Ospedaliera Ordine Mauriziano di Torino Coordinator of this site? Confirm its status | Turin | Italy | Recruiting |
| Ospedale Santa Maria della Misericordia Coordinator of this site? Confirm its status | Udine | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Integrata Verona Coordinator of this site? Confirm its status | Verona | Italy | Recruiting |
| Azienda Unita Locale Socio Sanitaria N 8 Berica Coordinator of this site? Confirm its status | Vicenza | Italy | Recruiting |
| IRCCS Istituti Fisioterapici Ospitalieri- Istituto Nazionale tumori Regina Elena Coordinator of this site? Confirm its status | - | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.