EUCTR2017-000123-28-BE进行中（未招募）1 期
Multiorgan Metabolic imaging response assessment of Abemaciclib: the MiMe-A trial - MIME-A
Institut Jules Bordet0 个研究点目标入组 185 人开始时间: 2018年9月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 185
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.Age = 18 years old
- •2.Female or Male
- •3.ECOG performance status = 1
- •4.Life expectancy of greater than 12 weeks
- •5.Must have histologically confirmed cancer corresponding to the predefined tumour subtypes (esophageal adenocarcinoma, esophageal squamous cell carcinoma, cholangiocarcinoma, urothelial cancer (progressive after immunotherapy), endometrial cancer) that are metastatic or non-resectable and refractory to standard platinum regimens (and progressive after immunotherapy for urothelial cancer if available).
- •6.Presence of at least one metabolically measurable tumour lesion on FDG-PET/CT, according to PERCIST. If previously irradiated, must have been more than 2 months before the baseline FDG PET/CT.
- •7.Measurable disease according to RECIST v1.1
- •8.Negative serum pregnancy test (for subjects of childbearing potential).
- •9.Women of childbearing potential must agree to the use of 1 highly effective method of contraception prior to study entry, during the course of the study and at least 3 months after the last administration of study treatment.
- •10.Men with childbearing potential partner must agree to use a condom during the course of this study and for at least 3 months after the last administration of the study treatment.
- •11.Adequate coagulation: International Normalized Ratio (INR) = 1.5 x ULN unless subject is receiving anticoagulant therapy as long as INR and activated partial thromboplastin time [aPTT] are within therapeutic range of intended use of anticoagulants
- •12.Adequate bone marrow function as defined below:
- •Hemoglobin = 10g/dl
- •Absolute neutrophil count = 1500/µL or 1.5x109/L
- •Platelets = 100000/µL or 100x109/L
- •Leukocytes = 3,000/mcL
- •13.Adequate liver function as defined below:
- •Serum total bilirubin within 1.5 × normal institutional limits (except for Gilbert syndrome where direct bilirubin should be <1.5 institutional ULN)
- •AST/ALT/ALP) levels < 3 × institutional upper normal limit (or ALT and AST <5 times upper limit of normal if liver metastases are present).
- •14.Adequate renal function as defined below:
- •Cockcroft-Gault creatine clearance >50ml/min
- •15.Completion of all necessary screening procedures
- •16.Ability to swallow capsules
- •17.Grade = 1 toxicity due to any previous cancer therapy according to the National Cancer Institute Common Terminology Criteria of Adverse Events (NCI-CTCAE v 5.0). Grade 2 is allowed in case of alopecia and peripheral sensory neuropathy.
- •18.If primary archived tumour tissue block available, it must be provided. (1 FFPE tumour tissue or 20 unstained slides)
- •19.Signed Informed Consent form (ICF) obtained prior to any study related procedure
- •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 185
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Have had chemotherapy, radiotherapy, immunotherapy, or targeted therapy within 3 weeks prior study enrolment
- •2.Receiving concomitantly any other experimental agents
- •3.Have received prior therapy with other CDK4/6 inhibitors
- •4.Known brain metastasis; unless the metastasis are asymptomatic and have been stable since at least 2 months prior to treatment start.
- •5.Have meningeal carcinomatosis
- •6.Have had major surgery within 28 days prior to the start of the treatment to allow for post-operative healing of the surgical wound
- •7.History of allergic reactions attributed to compounds of similar chemical or biologic composition
- •8.Bleeding diathesis, thromboembolic event, history of cardiovascular ischemic disease or cerebrovascular incident within the last six months
- •9.Uncontrolled concurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia
- •10.Substance abuse, psychiatric illness/social situations, any psychological, familial, sociological, geographical condition, significant medical or surgical condition currently uncontrolled by treatment that would limit compliance with study requirements or interfere with the patient’s ability to understand informed consent and participation in the study
- •11.Pregnant and/or lactating women
- •12.Uncontrolled Diabetes
- •13.Known history of HIV infection, or active hepatitis B or C requiring treatment with anti-viral therapy
- •14.Have received recent (within 28 days prior the enrolment) yellow fever vaccination
- •15.Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free and are deemed by the investigator to be at low risk for recurrence of that malignancy.
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