EUCTR2019-000616-28-AT进行中（未招募）1 期
Multicenter, randomized, double-blind, placebo-controlled, phase III clinical trial to investigate the efficacy and safety of Dronabinol in the Improvement of ChemOthErapy-induced and tumor-Related symptoms in patients with locally advanced or metastatic pancreatic cancer during first-line chemotherapy (DIsCOvER)
AGMT gGmbH0 个研究点目标入组 104 人开始时间: 2019年6月7日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 104
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
- •Male and female subjects aged =18
- •Patients with diagnosis of locally advanced, inoperable or metastatic pancreatic cancer, eligible for first-line chemotherapy with FOLFIRINOX or gemcitabine+Abraxane®
- •According to investigator life expectancy of > 4 months at screening
- •Female patients must either be post-menopausal or surgically sterilized or use a highly effective method of birth control (hormonal contraceptives, intra–uterine devices, or diaphragms with spermicide) for the duration of the study and/or must have a negative pregnancy test (female patients with childbearing potential only)
- •Willing and able to provide written informed consent.
- •Written informed consent given prior to any trial-related procedure not part of the normal medical practice.
- •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 37
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 67
排除标准
- •Patients who are members of the staff of the trial center, staff of the sponsor or CRO, the investigator him/herself or close relatives of the investigator.
- •Simultaneous participation in another interventional clinical trial, participation in another trial with less than 30 days or five half-lives of the IMP (whatever is longer) to screening, or previous participation in this trial.
- •Ineligible for chemotherapy treatment with FOLFIRINOX or gemcitabine+Abraxane®
- •Use of dronabinol or cannabis-based medicine with THC as constituent within 6 months before screening. A urine drug test will be performed during screening phase.
- •Use of marihuana within the last 4 weeks and unwillingness to abstain for the duration of the study. A urine drug test will be performed during screening phase.
- •Currently receiving chemotherapy or anticipated use of chemotherapy due to any condition not related to locally advanced or metastatic pancreatic cancer
- •History of or existing cardiac diseases or pathological findings (e.g. chronic insufficiency NYHA III/IV, severe arrhythmia, unstable angina pectoris, myocardial infarction within the past 6 months, significant QT-prolongation etc.), which in the opinion of the investigator might interfere with the safety or tolerability of the study treatment. An ECG has to be done to exclude pathological findings and must not be older than 3 months before screening or if none is available, has to be performed during the screening phase and assessed prior to randomization
- •Clinically relevant, severe pulmonary diseases, uncontrolled hypertension, or poorly controlled diabetes
- •History of or existing relevant CNS and/or psychiatric disorders (e.g. schizophrenia, psychosis, manic and/or depressive disorders, suicidal ideations, etc) which might interfere with the safety or tolerability of the study treatment. Patients with reactive depression are not excluded from participation.
- •Known current or past (within the last year prior to screening) alcohol, narcotics or drug abuse
- •Pregnancy or breast feeding
- •Known allergy to cannabinoids and other constituents of the investigational medicinal product
- •Intake of prohibited concomitant medication
- •Any other substantial medical condition that in the opinion of the investigator could create undue risk to the subject or could affect adherence with the trial protocol
- •Legal incapacity, limited legal capacity or any other condition which makes the subject unable to understand the subject information and informed consent form (ICF)
- •Patients unable or unwilling to waive driving motor vehicles or using machines especially during titration period
- •Unable or unwilling to comply with the protocol regulations
研究者
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