EUCTR2016-000081-33-DE进行中（未招募）1 期
Phase Ib/II study assessing the neo-adjuvant combination therapy of vinflunine with cisplatin followed by radical cystectomy in patients with muscle-invasive bladder cancer - JaNEO
igartis GmbH0 个研究点目标入组 42 人开始时间: 2016年2月9日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 42
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. Male or female patients aged = 18 years and = 75 years with legal capacity
- •2. Signed written informed consent
- •3. Histologically confirmed muscle-invasive urothelial cell carcinoma of the bladder (MIBC) with clinical T2-T4a (N0/Nx, M0) assessed by primary PDD-guided TUR-B and by the screening magnetic resonance imaging (MRI)
- •4. Confirmed adequate complete resection of all visible tumor during TUR-B according to current treatment guidelines before registration; the latest TUR-B must have been done = 8 weeks before registration
- •5. ECOG performance status of 0 or 1
- •6. Adequate bone marrow, renal and hepatic functions as evidenced by the following:
- •Absolute Neutrophil Count = 2,000 mm3 and = 7,500 mm3
- •Hemoglobin = 12 g/dL for the safety phase of the study; if the study treatment proved to be adequate tolerated during this safety phase, the threshold can be lowered to = 10 g/dL according to the decision of the study steering committee
- •Platelet count = 100,000 mm3
- •Serum albumin within normal range
- •Serum total bilirubin = 1.5 x upper limit of normal (ULN)
- •Transaminases (ALT, AST) = 1.5 x ULN
- •Creatinine clearance = 60 mL/min, calculated based on a 24h-measured creatinine clearance
- •Serum Urea < 25mg/100ml
- •7. Absence of psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; these conditions should be assessed with the patient before registration
- •8. Electrocardiogram (ECG) without modifications that suggest a high risk of occurrence of an acute clinical event (such as signs of angina pectoris or high-risk arrhythmia, etc.); cardiologist consultation is required, if relevant abnormalities are observed in the screening ECG-assessment
- •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 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. Prior systemic chemotherapy for any kind of malignancy; prior intravesical chemo¬therapy or treatment with BCG is allowed
- •2. Prior radiation of the pelvis or any prior radiation to >= 30% of the bone marrow
- •3. Evidence of lymph node (N+) or distant metastasis (M1) in the screening MRI assessment, iningcluding known brain metastases or leptomeneal involvement (however, brain-MRI-scans are not required to rule out CNS-involvement, unless there is clinical suspicion of central nervous system (CNS) disease)
- •4. Other malignancies except adequately treated basal carcinoma of the skin, localized prostate cancer Gleason = 6, in-situ cervix carcinoma or any other tumor with a disease free interval = 5 years
- •5. Peripheral neuropathy Grade = 2 NCI CTCAE v4.03 or hearing impairment Grade = 2 NCI CTCAE v.4.03
- •6. Any concurrent chronic system immune therapy or previous organ allograft
- •7. Weight loss >5% within the last 3 months before registration
- •8. Any other serious illness or medical condition including:
- •Infection requiring systemic anti-infective therapy within the last 2 weeks before registration
- •History of cardio-vascular disease that might compromise the safe administration of cisplatin
- •Dehydration requiring IV fluid substitution
- •Any medical condition that might not be controlled, e.g. patients with unstable angina pectoris, myocardial infarction < 6 months before registration or uncontrolled diabetes, congestive cardiac failure > NYHA grade I
- •9. Known hypersensitivity to the study drugs or to drugs with similar chemical structures
- •10. Treatment with any potent CYP3A4 inhibitor or inductor (e.g. ketoconazole, itraconazole, ritonavir, amprenavir, indinavir, rifampicine) or phenytoine; replacement of such treatment with alternative treatment options before start of study treatment is acceptable, if medically feasible and ethically acceptable
- •11. Treatment with hexamethylmelamin, pyridoxine, penicillamine or any other drug with known potential to affect the efficacy of cisplatin
- •12. Treatment with any other investigational or anti-cancer therapy = 30 days before registration
- •13. Pregnant or lactating female patients or female patients of childbearing potential with positive pregnancy test at screening
- •14. Women of child-bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 6 months after the study
- •15. Sexually active fertile men not using effective birth control during the study and up to 6 months after the study if their partners are women of child-bearing potential
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