KCT0004767尚未招募未知
DDR-Umbrella study of DDR (DNA-Damage Response) targeting agents in advanced biliary tract cancer
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 74
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1.Written informed consent and any locally-required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
- •2.Age > 20 years at time of study entry
- •3.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •4.Life expectancy of > 16weeks
- •5.Histologically proven BTC, including intrahepatic cholangiocarcinoma, extrahepatic bile duct cancer, gallbladder cancer, ampulla of vater cancer
- •6.Unresectable or recurrent
- •7.Failed to 1st-line chemotherapy for their advanced BTC (IO is not allowed)
- •8.At least one measurable lesion that can be accurately assessed at baseline by computed tomography (CT) (magnetic resonance imaging [MRI] where CT is contraindicated) and is suitable for repeated assessment as per RECIST 1.1.
- •9.Body weight >30kg (for durvalumab cohort)
- •10.Adequate normal organ and marrow function measured within 28 days prior to administration of study treatment as defined below:
- •?Haemoglobin =9.0 g/dL (>10 for olaparib cohort with no transfusion within the previous 28 days)
- •?Absolute neutrophil count (ANC) = 1.5 x 109/L
- •?Platelet count = 100 x 109/L
- •?Serum bilirubin =1.5 x institutional upper limit of normal (ULN). (This will not apply to patients with confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.)
- •?AST (SGOT)/ALT (SGPT) =2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be =5x ULN
- •?Patients must have creatinine clearance estimated of =51 mL/min using the Cockcroft-Gault equation or based on a 24 hour urine test :
- •Estimated creatinine clearance =(140-age [years]) x weight (kg) (x F)a
- •serum creatinine (mg/dL) x 72
- •?a where F=0.85 for females and F=1 for males.
- •11.Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1.
- •Postmenopausal is defined as:
- •-Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments
- •-Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post menopausal range for women under 50
- •-radiation-induced oophorectomy with last menses >1 year ago
- •-chemotherapy-induced menopause with >1 year interval since last menses
- •-surgical sterilisation (bilateral oophorectomy or hysterectomy)
- •12.Male patients must use a condom during treatment and for 6 months after the last dose of study drug when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception ([see appendix H for acceptable methods]) if they are of childbearing potential
- •13.Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
排除标准
- •1.Participation in another clinical study with an investigational product during the last 3 weeks
- •2.Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
- •3.Any previous treatment with Immune check point inhibitor, ATR or PARP inhibitor, including Olaparib.
- •4.Whole blood transfusions in the last 120 days prior to entry to the study in olaparib cohort (packed red blood cells and platelet transfusions are acceptable outside of 28 days prior to treatment
- •5.Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
- •6.Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) within 21 days of the first dose of study drug .2 The minimum washout period for immunotherapy is 42 days
- •7.Mean QT interval:
- •Mean resting corrected QT interval (QTc) >470 msec for females and >450 for men, obtained from 3 electrocardiograms (ECGs) 2-5 minutes apart using the Fredericia formula
- •-Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as congestive heart failure, unstable angina pectoris, acute myocardial infarction, hypokalaemia, congenital long QT syndrome, immediate family history of long QT syndrome or unexplained sudden death under 40 years of age, conduction abnormality not controlled with pacemaker or medication.
- •8.In AZD6738+Durvalumab cohort, current or prior use of immunosuppressive medication within 14days (use 28 days if combining durvalumab with a novel agent) before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. The following are exceptions to this criterion
- •The following are exceptions to this criterion:
- •-Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
- •-Systemic corticosteroids at physiologic doses not to exceed <<10 mg/day>> of prednisone or its equivalent
- •- Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
- •Also, Any of the following cardiac diseases currently or within the last 6 months (by New York Heart Association (NYHA) = Class 2 where applicable):
- •-Unstable angina pectoris
- •-Congestive heart failure or known reduced LVEF < 55%
- •-Acute myocardial infarction
- •-Conduction abnormality not controlled with pacemaker or medication e.g. complete left bundle branch block, third degree heart block
- •-Significant ventricular or supraventricular arrhythmias e.g. (patients with chronic rate-controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible)
- •-Patients at risk of brain perfusion problems, e.g., medical history of carotid stenosis or pre-syncopal or syncopal episodes, history of TIAs
- •Uncontrolled hypertension (grade 2 or above) requiring clinical intervention.
- •9.Any unresolved toxicity NCI CTCAE Grade =2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
- •?Patients with Grade =2 neuropathy will be evaluated on a case-by-case basi
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