EUCTR2018-004826-27-DK进行中（未招募）1 期
A Single Center, Randomized, Phase II Study of the combination of Cisplatin and Gemcitabine with or without Tocilizumab, an IL-6R inhibitor, as first-line treatment in patients with locally advanced or metastatic biliary tract cancer. - BILTRACTO
Department of Oncology, Herlev & Gentofte Hospital0 个研究点目标入组 166 人开始时间: 2019年2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）
- 发起方
- 入组人数
- 166
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
- •Signed informed consent. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care
- •Male or non-pregnant, non-lactating females who are =18 years of age at the time of signing the informed consent form (ICF)
- •Histological or cytological biliary tract adenocarcinoma. Malignant unspecified tumor cells in cytological specimen are allowed after investigator assessment, mixed histology including adenosquamous carcinoma is allowed
- •Unresectable locally advanced or metastatic biliary tract carcinoma
- •ECOG/WHO Performance Status (PS) 0-1
- •= 4 weeks since prior major surgery, = 2 weeks since prior minor surgery
- •Measurable disease using the RECIST1.1 criteria, defined as lesions that can be measured in at least one dimension and which have not been previously irradiated. Longest diameter = 20 mm with conventional techniques or = 10 mm with spiral CT scan or MRI
- •Fertile women of childbearing potential (defined as a sexually mature woman who (1) has not undergone hysterectomy [the surgical removal of the uterus] or bilateral oophorectomy [the surgical removal of both ovaries] or (2) has not been naturally postmenopausal for at least 24 consecutive months [ie, has had menses at any time during the preceding 24 consecutive months]) must use highly effective contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; or vasectomized partner) while on study IP; and for 3 months following the last dose of chemotherapy; and has negative serum pregnancy test (ß -hCG) result at screening
- •Male subjects: must practice true abstinence (True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception) or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following IP discontinuation, even if he has undergone a successful vasectomy.
- •Acceptable hematology parameters defined as:
- •Absolute neutrophil count (ANC) = 1.5 x 10?/L
- •Platelet count = 100 x 10?/L
- •Acceptable liver function with:
- •Serum bilirubin < 1.5 x upper limit of normal (ULN)
- •AST and ALT <2.5 x ULN (or 5 x ULN in the presence of liver metastases)
- •Acceptable renal function with an eGFR = 60 mL/min/1,73m2
- •Subjects must have signed and dated a CHOCA approved written informed consent form in accordance with regulatory and institutional guidelines.
- •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 83
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 83
排除标准
- •Electrocardiogram (ECG) with significant modifications suggesting a high risk of occurrence of angina pectoris or high risk of arrhythmia
- •Other malignancies, except adequately treated basal carcinoma or squamous cell carcinoma of the skin or in-situ cervix carcinoma or incidental prostate cancer (T1a, Gleason score = 6, PSA < 0.5 ng/ml), or any other tumor with disease-free survival of = 5 years
- •History of serious or concurrent illness or uncontrolled medical disorder; any medical condition that might be aggravated by chemotherapy treatment or which could not be controlled; including, but not restricted to:
- •Active infection requiring antibiotics within 2 weeks before the study inclusion
- •Concurrent congestive heart failure NYHA (class III - IV)
- •Unstable angina pectoris, or myocardial infarction within 6 months and/or prior poorly controlled hypertension
- •Inflammatory bowel disease (colitis, Crohns) or other serious gastrointestinal conditions associated with risk of perforation
- •Hearing impairment grade = 2 according to CTCAE v 5.0
- •Peripheral neuropathy grade = 2 according to CTCAE v 5.0.
- •Evidence of active tuberculosis (TB), or suspected latent TB based on medical history (e.g. history of untreated TB or TB exposure) without a subsequent negative TB test
- •Concomitant use of immunosuppressive or myelosuppressive medications that would in the opinion of the investigator, increase the risk of serious neutropenic complications
- •No known or suspected allergy to the investigational agents or any agents given in association with this trial
- •Pregnant or lactating women
- •Any psychological, familial, sociological, or geographical condition which does not permit protocol compliance and medical follow-up
- •Enrollment in any other clinical protocol or investigational study with an interventional agent or assessments that may interfere with study procedures
研究者
相似试验
进行中（未招募）
不适用
A Phase IIa, Single-Center Study, Investigating the Short-Term Renal Hemodynamic Effects, Safety and Pharmacokinetics/Pharmacodynamics of Oral Tolvaptan (OPC-41061) in Subjects with Autosomal Dominant Polycystic Kidney Disease at Various Stages of Renal FunctioAutosomal Dominant Polycystic Kidney Disease (ADPKD)MedDRA version: 12.1Level: LLTClassification code 10036046Term: Polycystic kidney, autosomal dominantEUCTR2010-019025-33-NLOtsuka Pharmaceutical Development Commercialization, Inc.36
已完成
2 期
Comparison of the efficacy of digital versus traditional suction drainage system in the treatment of pneumothorax with air leakPneumothorax with air leakSurgery - Surgical techniquesRespiratory - Other respiratory disorders / diseasesACTRN12613000931774Department of Thoracic Surgery, General and Oncological Surgery, Medical University of Lodz60
尚未招募
不适用
A Phase II Clinical Trial to Evaluate the Recombinant Human Type 5 Adenovirus Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV)EbolaEbola Virus DiseasePACTR201509001259869Ministry of Health & Sanitation500
已完成
2 期
A Phase 2a, Single-Center Study Investigating the Short-Term Renal Hemodynamic Effects, Safety and Pharmacokinetics/ Pharmacodynamics of Oral Tolvaptan in Subjects with Autosomal Dominant Polycystic Kidney Disease at Various Stages of Renal FunctioNL-OMON34527Covance36
进行中（未招募）
不适用
A Randomized, Multi-Center, Phase II Study to Investigate the Safety and Efficacy of SDX-101 (R-etodolac) in Combination with Chlorambucil, and that of Chlorambucil alone, in Patients with Chronic Lymphocytic Leukemia (CLL) -Chronic Lymphocytic Leukemia (CLL)EUCTR2004-000440-24-SECephalon UK Limited80