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 - MEET URO 12

DIPARTIMENTO DI ONCOLOGIA-UNIVERSITA' DEGLI STUDI DI TORINO0 个研究点目标入组 77 人开始时间: 2020年11月4日最近更新: 2021年1月5日

研究概览

暂无简介。

•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.

发起方

DIPARTIMENTO DI ONCOLOGIA-UNIVERSITA' DEGLI STUDI DI TORINO