EUCTR2017-001591-35-IT进行中（未招募）1 期
Multicenter, prospective, non-randomized, phase II trial designed to evaluate the activity of Cabazitaxel in patients with advanced Adreno-Cortical- Carcinoma progressing after previous chemotherapy lines - CABaCC
AZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA0 个研究点目标入组 25 人开始时间: 2021年9月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 25
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
- •Histologically confirmed diagnosis of ACC
- •Locally advanced or metastatic disease not amenable to radical surgery resection
- •Radiologically monitorable disease
- •Progressing disease after one to three cytotoxic chemotherapy regimes (including a platin-based protocol)
- •ECOG performance status 0-2
- •Life expectancy = 3 months
- •Age = 18 years
- •Adequate bone marrow reserve (neutrophils = 1500/mm³ and platelets > 100.000/mm³)
- •Effective contraception in pre-menopausal female and male patients
- •Patient´s written informed consent
- •Ability to comply with the protocol procedures
- •Mitotane intake should be stopped one months before the study entry
- •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 21
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •History of prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, or other treated malignancies with no evidence of disease for at least three years.
- •Serum creatinine > 1.5 x ULN, BCC <60 mL/min) or hepatic insufficiency (ALT / AST > 1.5 x ULN or ALT/AST >5 x ULN if liver function abnormalities are due to the underlying malignancy and/or total serum bilirubin > 2.5 x ULN) Hemoglobin <10.0 g/dL;
- •Total bilirubin >1x ULN,
- •Creatinine < 1.5 ULN;
- •Decompensated heart failure (ejection fraction <45%), myocardial infarction or revascularization procedure during the last 6 months, unstable angina pectoris, uncontrolled cardiac arrhythmia
- •Pregnancy or breast feeding
- •Any other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study
- •Patients with serum levels of mitotane (evaluated one week before the study start) in the therapeutic range (14-20 mcg/ml).History of severe hypersensitivity reaction (=grade 3) to docetaxel
- •History of severe hypersensitivity reaction (=grade 3) to polysorbate 80 containing drugs
- •Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus)
- •Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments) (see Annex 1 and Annex 2)
- •Concomitant vaccination with yellow fever vaccine
研究者
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