EUCTR2016-004118-84-IT进行中（未招募）1 期
A multicenter, phase I-II trial of gemcitabine plus oxaliplatin and nbb-paclitaxel in subjects with advanced (unresectable or metastatic) biliary tract cancer (gallbladder cancer, cancer of the extrahepatic bile duct, intrahepatic cholangiocarcinoma and ampullary carcinoma). - A multicenter, phase I-II trial of gemcitabine plus oxaliplatin and nbb-paclitaxel in subjects with
IRCCS ISTITUTO CLINICO HUMANITAS0 个研究点目标入组 85 人开始时间: 2018年9月17日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 85
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Written, signed informed consent
- •2.Male or female aged 18 years or older
- •3.Histologically or citologically-confirmed advanced (unresectable or metastatic) BTC (gallbladder cancer, cancer of the extrahepatic bile duct, intrahepatic cholangiocarcinoma and ampullary carcinoma)
- •4.Measurable or evaluable but non-measurable disease according to RECIST v. 1.1
- •5.Chemotherapy-naïve (prior chemotherapy in the adjuvant setting completed more than 6 months before the trial entry is accepted)
- •6.Adequate bone marrow, liver, and renal function
- •7.ECOG PS 0-1
- •8.Life expectancy of at least 12 weeks
- •9.Negative serum pregnancy test for women of childbearing potential;
- •10.Adoption of adequate contraceptive methods when applicable :
- •?Women of child-bearing potential must use the following adequate contraceptive methods during all the study and for 1 month after completion of study treatment: abstinence, tubal ligation, oral contraception or transdermal contraceptives, copper intrauterine device, vasectomy of the partner. It is unknown whether the experimental drugs interact or have effect on the hormonal contraceptives functioning: if patients are using hormonal contraceptives, must be associated a barrier method of contraception.
- •?For male patients with female partners of childbearing potential, agreement to use a barrier method of contraception from the first dose of treatment and for 6 months after completion of study treatment.
- •11.Male patients mustn’t donate sperm during the treatment with nab-paclitexel and for 6 months after completion of study treatment.
- •12.Agreement not to donate blood during the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1.Peripheral neuropathy of grade 2 or greater by Common Terminology Criteria for Adverse Events (CTCAE) 4.0. In CTCAE version 4.0 grade 2 sensory neuropathy is defined as moderate symptoms; limiting instrumental activities of daily living (ADLs)
- •2.Previous systemic treatment for advanced disease
- •3.Known symptomatic brain metastases or carcinomatous meningitis
- •4.Severe or uncontrolled systemic disease and/or active or uncontrolled infection
- •5.Women who are currently pregnant or breast feeding
- •6.Previous or current malignancies of other histologies within the last 3 years, with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin
- •7.Known hypersensitivity to nab-paclitaxel, gemcitabine, oxaliplatin or any of the excipients
研究者
相似试验
未知
2 期
A Phase II multicenter trial of Gemcitabine in combination with R1415 (erlotinibhydrochloride) in patients with unresectable pancreatic cancer (locally advanced or metastatic)Pancreatic cancerJPRN-jRCT2080220332Chugai Pharmaceutical Co., Ltd.
已完成
2 期
Multicenter phase II trial of gemcitabine and S-1 for gallbladder cancergallbladder cancerJPRN-UMIN000001267agoya University Hospital20
已完成
2 期
Randomized phase II study of gemcitabine monotherapy versus gemcitabine with an EPA-enriched oral supplement in advanced pancreatic cancer (YCOG001)Pancreatic cancerJPRN-UMIN000003658kanagawa cancer center66
已完成
2 期
Phase II trial of gemcitabine monotherapy in the third or further line for pretreated patients with advanced non-small cell lung canceron-small cell lung cancerJPRN-UMIN000017791Dept.Repiratory Medicine, Osaka Police Hospital21
进行中（未招募）
不适用
Phase II trial of the addition of gemcitabine to 131I-MIBG therapy in paediatric patients with relapsed or progressive neuroblastomarelapsed or progressive neuroblastoma in pediatric patients of 1 to 18 yearsEUCTR2007-007974-45-DEAMC47