2024-519519-32-00招募中2 期
A Phase II, Randomized, Trial of Niraparib Versus Best Supportive Careas 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)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 77
- 试验地点
- 20
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Progression free survival (PFS)
Progression free survival (PFS)
次要结局
- Proportion of objective answers
- Duration of the answer
- Global survival
- Proportion of progression-free patients at 6 months from randomization.
- Safety and tolerability
- Quality of life (patient-reported outcomes)
研究者
Massimo Di Maio
Scientific
Universita' Degli Studi Di Torino
研究点 (20)
Loading locations...
相似试验
招募中
3 期
Vorasidenib for the treatment of IDH-mutant astrocytoma after standard chemoradiotherapy2024-519404-27-00Europese Organisatie Voor Onderzoek En Behandeling Van Kanker Organisation Europeenne Pour La Recherche Et Le Traitement Du Cancer European Organi247
招募中
3 期
A Phase 3 Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants with Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)2023-506365-64-00Janssen - Cilag International211
招募中
2 期
Phase II Study Evaluating Ivosidenib Maintenance After SOC Adjuvant Chemotherapy in Curative mIDH1 CholangiocarcinomaCholangiocarcinomaCholangiocarcinomaNCT07260175Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest40
招募中
2 期
Phase II study evaluating the addition of elacestrant, an oral selective estrogen receptor degrader (SERD), to standard-of-care olaparib in patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with gBRCA1/2 mutations – ELEMENT2023-504925-38-00GBG Forschungs GmbH176
招募中
3 期
Prevention of thrombotic events in the context of long distance flights2024-515630-33-00Klinikum der Universitaet Muenchen AöR27,698