A Phase II, Randomized, Trial of Niraparib Versus Best Supportive Care as Maintenance Treatment In Patients With Locally Advanced Or Metastatic Urothelial Cancer Whose Disease Did Not Progress After Completion Of First-line Platinum-containing Chemotherapy- MEET URO 12
- Conditions
- locally non-resectable or metastatic local urothelial transitional tumor (transitional cell carcinoma both with pure and mixed histology).MedDRA version: 21.1Level: LLTClassification code 10046703Term: Urogenital neoplasm NOSSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-004147-24-IT
- Lead Sponsor
- DIPARTIMENTO DI ONCOLOGIA-UNIVERSITA' DEGLI STUDI DI TORINO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 77
Established histological or cytological diagnosis of non-resectable or metastatic locally advanced non-resectable urothelial transitional tumor (transitional cell carcinoma both with pure and mixed histology);
Measurable disease according to RECIST (v1.1) before starting the first chemotherapy line;
The first chemotherapy line must have been performed with at least 4 cycles and no more than 6 cycles of a regimen containing platinum (cisplatin or carboplatin);
Absence of disease progression after completion of the first chemotherapy line (complete response, partial response or disease stability according to RECIST criteria v1.1);
Patients should be enrolled within 28 days of a radiological survey demonstrating disease stability or partial / complete disease response and no more than 42 days after receiving the last dose of chemotherapy;
Availability of a blood sample to determine the state of germline mutations of BRCA genes;
Availability of a sample of tumor tissue in the archive to determine the status of the genes involved in the mechanism of homologous recombination (HRD);
ECOG performance status 0-1.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 38
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 39
Known hypersensitivity to the components of Niraparib.
Note active liver disease.
Previous treatment with a PARP inhibitor agent
Pre-existing toxicity due to previous therapies of degree> 1 according to NCI CTCAE v4.0; however, alopecia, sensory neuropathy (grade 2 or lower), or other grade 2 or lower toxicities that do not pose a risk to the patient at the trial according PI is accepted.
Known history of bone marrow compression or meningeal carcinosis or evidence of symptomatic brain disease or leptomeningi at screening CT or RMN images. Encephalic metastases treated, stable and asymptomatic are permitted.
The diagnosis of other cancers in the last 2 years prior to randomization; are admitted and therefore exceptions are cutaneous squamous tumor or cutaneously treated skin basaloma, in situ carcinoma of the breast or of the cervix, the low-grade prostatic tumor in active surveillance or the prostate tumor already subjected to prostatectomy or radiotherapy which does not demonstrate randomization signs of disease recovery.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Compare maintenance treatment with Niraparib associated with the best supportive therapy the best supportive therapy alone in patients with locally advanced or metastatic urothelial tumor who have achieved disease control (objective response or disease stability) with a first chemotherapy line containing platinum, in order to determine whether maintenance treatment with Niraparib is effective in terms of prolonging disease progression-free survival.;Secondary Objective: NA;Primary end point(s): Progression free survival (PFS);Timepoint(s) of evaluation of this end point: 36 months
- Secondary Outcome Measures
Name Time Method