EUCTR2007-001826-28-GB进行中（未招募）1 期
A phase II/III, randomised, two-arm comparison of maintenance lapatinib versus placebo after firrst-line chemotherapy in patients with HER1 and/or HER2 over expressing locally advanced or metastatic bladder cancer. - LaMB
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 232
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
入选标准
- •Histologically confirmed metastatic or locally advanced transitional cell carcinoma of the urothelium.
- •Stage IV disease at entry of the study
- •Able to commence study treatment within 10 weeks of completing chemotherapy
- •HER1-positive (2+ or 3+ intensity on immunohistochemical staining (IHC) and/or amplification of the HER1 gene on fluorescence in situ hybridization (FISH)) and/or HER2-positive (2+ or 3+ intensity on immunohistochemical staining (IHC) and/or amplification of the HER2 gene on FISH)
- •Objective response or stable disease following at least 4 and no more than 8 cycles of first-line chemotherapy. The chemotherapy regimen includes any widely accepted regimen for bladder cancer. Patients who do not receive cisplatin remain eligible. Dose reduction and delays in treatment between cycles are acceptable.
- •Adequate haematological function (ANC =1.0 x 109/l, Hb = 8.0 g/dL and platelet count to =75 x 109/l).
- •Adequate liver function tests (ALT/AST < 2 x ULN, bilirubin level < 1.5 x ULN).
- •Normal cardiac function with a left ventricular ejection fraction of at least 50% (as assessed by quantitative echocardiogram)
- •ECOG performance status 0-3
- •Age = 18 years
- •If the patient is of childbearing potential, she agrees to: comply with effective contraceptive measures, has been using adequate contraception since the last menses, will use adequate contraception during the study, and has a negative pregnancy test within one week of study entry
- •Written informed consent prior to admission to this study
- •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 21
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •Patients who progress by RECIST on first-line chemotherapy and require 2nd line chemotherapy. Patients with progression of disease who do not fulfil RECIST criteria for PD and do not require 2nd line therapy are eligible. The original pre-treatment CT and post treatment CT should be compared to assess response.
- •More than one line of prior chemotherapy for metastatic or locally advanced disease (Neoadjuvant/adjuvant chemotherapy is acceptable).
- •Serum creatinine concentration > 3.0 x ULN and/or creatinine clearance <30 ml/min (using EDTA or Cockcroft and Gault)
- •Have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
- •Previous treatment with study medication and/or known hypersensitivity to the study medication.
- •Past or current history of other neoplasms, except for:
- •o Any non life-threatening tumours that have been curatively treated.
- •Significant cardiac disease, including angina pectoris, severe cardiac arrhythmia requiring medication, severe conduction abnormalities, clinically significant valvular disease, cardiomegaly, ventricular hypertrophy, poorly uncontrolled hypertension (resting diastolic blood pressure >115 mmHg), prior myocardial infarction, CHF, or other cardiomyopathy
- •Serious intercurrent medical or psychiatric illness, including serious active infection
- •Concurrent treatment with other experimental drugs.
- •Less than 4 cycles or more than 8 cycles of standard chemotherapy
- •Greater than 10 week delay from finishing 1st line chemotherapy to starting maintenance therapy.
- •Pregnant or nursing women
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