EUCTR2012-004895-21-GB进行中（未招募）1 期
Phase II randomised placebo controlled NEOadjuvant chemotherapy study of Nintedanib with Gemcitabine and Cisplatin in locally advanced muscle invasive BLADder cancEr - NEO-BLADE Version: 2
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •Aged 18 or over
- •Histologically proven invasive TCC of bladder
- •Localised muscle invasive carcinoma
- •ECOG performance status grade 0 to 1
- •Adequate haematological function as evidenced by:
- •a) Haemoglobin >10.0g/dl
- •b) White blood cell count >3.0 x10 9/L
- •c) Absolute neutrophil count >1.5 x10 9/L
- •d) Platelet count >100,000/mm3
- •Adequate Hepatic function as evidenced by:
- •a) Total Bilirubin <1.5 xULN
- •b) Alkaline Phosphatase (ALP) levels <2 xULN
- •c) Aspartate transaminase (AST)/Alanine transaminase (ALT) levels <3.0 xULN
- •Glomerular Filtration Rate (GFR) > 60ml/min* measured by either**:
- •a)EDTA clearance
- •b)24 hr Urine collection
- •c)The Cockcroft-Gault calculation
- •As per local standard practice;
- •Available for 12-month follow up
- •Agree to use adequate contraception which they agree to continue for 3 months after the study treatment
- •Suitable for treatment with Gemcitabine and Cisplatin
- •Able to receive radical treatment
- •Able to provide written informed consent
- •*Following safety review from the safety sub-study, the ISDMC and the funder will decide whether the data indicates that it is suitable for patients with impaired GFR (40-60 ml/minute) to be included in the trial using split dose cisplatin 35 mg/m2 on day 1 and day 8 and which dose of Nintedanib/Placebo will be used for the main study.
- •**The same method used to measure GFR at screening should be used for each patient throughout the trial.
- •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 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Pregnant or breast feeding
- •Concomitant or previous malignancy which is likely to interfere with protocol treatment
- •Evidence of significant clinical disorder, or laboratory finding which, in the opinion of the investigator, makes it undesirable for the patient to participate in the trial.
- •Male and female patients (of childbearing potential* not using adequate contraception and do not agree to do so for 3 months following Nintedanib treatment
- •Evidence of metastatic disease
- •Patients who require therapeutic anticoagulation (except low-dose heparin and/or heparin flush as needed for maintenance of an in-dwelling intravenous device) or anti-platelet therapy (except for low-dose therapy with acetylsalicylic acid <325 mg per day)
- •Hypersensitivity to nintedanib, peanut or soya, or to any of the excipients of nintedanib
- •* Patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation/salpingectomy, or post-menopausal for at least two years.
- •Note Patients with hydronephrosis can be included if the kidney/ureter
- •has been stented, or nephrostomy has been inserted, and renal
- •function has been maintained to allow neoadjuvant chemotherapy
- •to be administered satisfactorily
研究者
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