EUCTR2019-001459-38-GB进行中（未招募）1 期
A Phase II study of selective HDAC6 inhibition with KA2507 in advanced biliary tract cancer previously treated with standard of care chemotherapy (ABC-11) - ABC-11
Karus Therapeutics Limited0 个研究点目标入组 40 人开始时间: 2019年12月10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
- 40
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
- •2.Signed informed consent
- •3.Histological or cytological diagnosis of advanced (i.e. metastatic disease, or irresectable locally advanced, or recurrent) BTC (to include intra or extra hepatic and gallbladder; ampullary cancer will not be included)
- •4.Patient must have disease amenable to biopsy and be willing to undergo this procedure at baseline and on-treatment
- •5.Clear evidence of disease progression following standard of care first line therapy as defined by RECIST Version 1.1, OR clear evidence of disease progression based on the emergence of non-measurable disease (e.g. new cytologically confirmed ascites, pleural or pericardial effusion). Patients intolerant of first-line standard of care chemotherapy will also be eligible provided there is evidence of disease progression
- •6.At least one target lesion measurable as defined by RECIST Version 1.1 using computed tomography (CT) or magnetic resonance imaging (MRI)
- •7.Eastern Co-operative Ongology Group (ECOG) performance status Grade 0 or
- •8.Adequate biliary drainage, with no evidence of ongoing infection
- •9.Estimated life expectancy >3 months
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •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 27
排除标准
- •1. Unresolved or unstable adverse effects of prior chemotherapy or radiotherapy, i.e. =Grade 2 according to CTCAE Version 5.0 except alopecia and infertility
- •2. Clinical evidence of cerebral metastases
- •3. History of previous malignancy that could interfere with response evaluation
- •4. Concurrent treatment with other investigational drugs within 4 weeks or 6 half-lives of initiating treatment
- •5.Inadequate renal, liver, or haematological function defined as any of:
- •Significant renal impairment, defined as estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
- •Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >5 x upper limit of normal (ULN)
- •-Neutropenia (absolute neutrophil count [ANC]<1.5 x 109/L)
- •-Platelets <100 x 109/L
- •-Haemoglobin =9 g/dL). NB the use of transfusion to achieve desired haemoglobin is acceptable
- •-Total bilirubin =1.5 x ULN (except for patients with known Gilbert’s syndrome)
- •6.Known haemoglobinopathy due to haemoglobin S or haemoglobin C disease, a or ß thalassemia, or glucose-6-phosphate dehydrogenase deficiency
- •7.Concomitant use of dapsone
- •8.Untreated severe thyroid dysfunction (hypo- or hyper-thyroidism)
- •9.Significant heart disease defined as any of the following:
- •-New York Heart Association Grade 3 or 4 symptomatic heart failure
- •-Symptomatic cardiomyopathy
- •-Unstable angina or acute myocardial infarction within 3 months
- •-Cardiac ventricular arrhythmia within 3 months that is not controlled by drug therapy and/or by cardiac ablation
- •-QT interval corrected using Fridericia’s formula (QTcF) >470 ms on screening ECG or history of Torsades de pointes
- •10.Any other concurrent severe and/or uncontrolled medical or surgical condition which, in the view of the Investigator, could compromise the patient’s participation in the study
- •11.Patients with active hepatitis infection (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C virus (HCV). Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen test) are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid
- •12.Active infection requiring antibiotics within two weeks prior to treatment
- •13.Males who are unable or unwilling to use barrier contraception during treatment and for 3 months after
- •14.Women who are pregnant, breast-feeding or either unable or unwilling to use effective means of contraception during treatment
- •15.Patients who are unable to swallow capsules and/or have a surgical or anatomical condition that precludes swallowing and absorbing oral medication on an ongoing basis
- •16.Any other condition that would, in the Investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures
研究者
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