P-ACC Trial - Phase II, single arm, multicenter, open-label study of PARP inhibitors + cisplatin in Recurrent and/or Metastatic Adenoid Cystic Carcinoma - P-ACC INDAGA

AZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA0 个研究点目标入组 27 人开始时间: 2023年1月10日最近更新: 2023年9月11日

适应症

试验速览

暂无简介。

•Age = 18 years;
•- Signature Informed Consent;
•- Histological diagnosis of ACC;Primary ACC not amenable of curative standard of care treatments (i.e., unresectable tumors, and/or lesions impossible to irradiate for any reason);
•- Locoregional recurrent ACC not amenable to curative standard of care treatments (i.e., unresectable tumors, and/or lesions impossible to re-irradiate for any reason) with a history of clinical or symptomatic disease progression within 6 months;
•- Metastatic ACC (distant spread) not amenable to surgical therapy or radiotherapy and with a history of clinical or symptomatic disease progression within 6 months;
•- Prior treatment with targeted therapy and/or chemotherapy is allowed if performed more than 4 weeks since protocol start:
•- ECOG PS of 0-1; - Adequate hematologic and organ functions
•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 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 7

•History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational agent;
•Previous treatment with PARPi;
•Uncontrolled central nervous system (CNS) metastases, including leptomeningeal metastases;
•Failure to recover to grade 1 or baseline from all toxic effects of previous chemotherapy, radiation therapy, biologic therapy, immunotherapy, and/or experimental therapy;
•Medical conditions that might interfere with study treatment;
•Women must not be pregnant or breastfeeding; pregnant women are excluded from this study.

发起方