EUCTR2017-000580-32-IT进行中（未招募）1 期
Cabozantinib plus Ddurvalumab in patients with advanced and chemotherapy-treated bladder carcinoma, of urothelial and non-urothelial histology: an open-label, single-centre, phase 2, single-arm proof-of-concept trial: ARCADIA study - hARnessing CAbozantinib and Durvalumab Immuno-oncology Association: ARCADIA study
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 122
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
- •Written informed consent.
- •Age =18 years.
- •Body weight >30kg
- •Histologically-confirmed diagnosis of UC or variant histologies (e.g. squamous cell carcinoma, adenocarcinoma, micropapillary tumors, BUT excluding pure small cell carcinoma) of the bladder or the urothelium.
- •Either bladder, urethral, or upper tract primary tumor will be allowed.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- •Life expectancy of at = 12 weeks.
- •Availability of tumor tissue for PD-L1 IHC assay.
- •Measurable and non-measurable disease will be included (e.g. patients with bone metastases only will be allowed for inclusion).
- •Failure of 1 or 2 cisplatin-based conventional chemotherapy regimens for metastatic disease (2nd-to-3rd line only).
- •Neoadjuvant/adjuvant regimens will be counted provided that a relapse occurred with 6 months of the last cycle of chemotherapy.
- •Adequate function of the organs:
- •a. Absolute neutrophil count (ANC) = 1500/mm3
- •b. Platelets = 100,000/mm3
- •c. Hemoglobin = 9 g/dL (= 90 g/L).
- •d. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 3.0 × upper limit of normal.
- •e. Total bilirubin = 1.5 × the upper limit of normal. For subjects with Gilbert’s disease = 3 mg/dL
- •g. Serum creatinine = 2.0 × upper limit of normal or calculated creatinine clearance = 30 mL/min using the Cockroft-Gault equation
- •h. Lipase < 2.0 times the upper limit of normal (ULN)
- •Recovery to baseline or = Grade 1 Common Terminology Criteria for Adverse Events (CTCAE) v45 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy
- •Ability to swallow tablets
- •Contraception for sexually active fertile patients and their partners. Of note, a barrier method is recommended in addition to the use of steroid hormonal contraceptives, because the effects of cabozantinib on the pharmacokinetics of the latter are unknown.
- •Evidence of post menopausal status or serum pregnancy test for female pre-menopausal subject
- •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 82
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •Patients taking regular oral steroids, above the allowed limit of 10mg/day methylprednisolone or analogues, for any reason. Patients must not have had steroids for 28 days prior to study entry.
- •Malignancies other than bladder carcinoma within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ treated surgically with curative intent) or localized prostate cancer treated with curative intent and absence of prostate-specific antigen (PSA) relapse or incidental prostate cancer (Gleason score = 3 + 4 and PSA < 10 ng/mL undergoing active surveillance and treatment naive).
- •Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results.
- •Active or untreated CNS metastases as determined by computed tomography (CT) or magnetic resonance imaging evaluation during screening and prior radiographic assessments.
- •Patients with treated asymptomatic CNS metastases are eligible, provided they meet all of the following criteria (see pg 29)
- •Pregnant female patients. All female patients of childbearing potential with a positive pregnancy test within 2 weeks prior to the first dose of study treatment will be excluded from the study.
- •Clinically significant cardiovascular disease, for example, myocardial infarction (within 3months prior to enrolment), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication (beta-blockers and digoxin are allowed)
- •Uncontrolled hypertension, stroke or other ischemic or thromboembolic event (DVT, PE) within 6 months before first dose of cabozantinib
- •Severe infections within 4 weeks prior to enrolment in the study including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia.
- •Major surgical procedure within 4 weeks prior to enrolment or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis. Complete wound healing from major surgery must have occurred 1 month before inclusion and from minor surgery (eg, simple excision, tooth extraction) at least 10 days before inclusion. Subjects with clinically relevant ongoing complications from prior surgery are not eligible
- •Concomitant anticoagulation with oral anticoagulants or platelet inhibitors
- •Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
- •Patients with a history of aneurysms
研究者
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