EUCTR2004-001118-15-ES进行中（未招募）1 期
Phase II multicenter,open-label, clinical and pharmacokinetic study of Aplidin® as a 3-hour infusion every 2 weeks, in patients with advanced or metastatic transitional cell carcinoma of the urothelium, relapsing or progressing after first line chemotherapy
Pharma Mar, S.A0 个研究点目标入组 0 人开始时间: 2005年3月31日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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.Written informed consent obtained from the patient before starting any study-specific procedure. If any patient is unable to give consent, it may be obtained from the patient’s legal representative if in accordance with local laws and regulations.
- •2.Transitional cell carcinoma of the urothelium of the bladder, urether or renal pelvis, with the following characteristics:
- •·Confirmed pathological diagnosis.
- •·Advanced (locally advanced or metastatic) and / or non-resectable disease (surgical exeresis does not eradicate all the macroscopic disease).
- •·With documented objective progression according to the RECIST criteria within 6 months prior to registration.
- •·Presence of at least one measurable lesion (RECIST). In case of a single measurable lesion, pathological proof of malignancy is mandatory.
- •3.One previous line of systemic chemotherapy. All prior therapies should have been finished at least 3 weeks before patient registration.
- •4.Prior radiotherapy: a minimum of 4 weeks (8 weeks in case of extensive prior radiotherapy) must have elapsed between the end of the prior radiotherapy and entry into the protocol. Previously irradiated lesions may not be used as indicator lesions unless a new lesion has occurred in a previously irradiated area.
- •5.Recovery from any toxicity derived from previous treatments. The presence of alopecia and NCI-CTC grade < 2 symptomatic peripheral neuropathy is allowed.
- •6.Age > 18 years.
- •7.Performance status (ECOG) < 2
- •8.Life expectancy > 3 months.
- •9.Adequate renal, hepatic, and bone marrow function (assessed < 14 days before inclusion in the study):
- •·Neutrophil count ³ 1.5 x 109/L
- •·Platelet count ³ 100 x 109/L
- •·Haemoglobin ³ 10 g/dL
- •·Creatinine clearance ³ 40 ml/min (calculated from the Cockcroft and Gault formula, Appendix 3)
- •·Serum bilirubin * 1.5 mg/dL and alkaline phosphatase * 2.5 x ULN (< 5 x ULN in case of extensive bone metastases)
- •·AST, ALT < 2.5 x ULN (< 5 x ULN in case of liver metastasis).
- •·Albumin > 25 g/L
- •10.Left ventricular ejection fraction within normal limits.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Prior therapy with Aplidin®.
- •2.More than one line of prior systemic chemotherapy.
- •3.Pregnant or lactating women; men and women of reproductive potential who are not using effective contraceptive methods.
- •If subject is female, she is eligible to enter and participate in this study if she is of:
- •a.non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or,
- •b.child-bearing potential, has a negative pregnancy test (urine or serum) at screen, and agrees to one of the following:
- •·Complete abstinence from intercourse from 2 weeks prior to administration of the study drug, throughout the study, and for a time interval after completion or premature discontinuation from the study to account for elimination of the investigational drug (a minimum of 5 plasma half-lifes); or,
- •·Female sterilization; or,
- •·Sterilization of male partner; or,
- •·Implants of levonorgestrel; or,
- •·Injectable progestogen; or,
- •·Oral contraceptive (combined or progestogen only); or,
- •·Any intrauterine device (IUD) with published data showing that the lowest expected failure rate is less than 1% per year (not all IUDs meet this criterion); or,
- •·Double barrier method (2 physical barriers or 1 physical barrier plus spermicide); or,
- •·Any other method with published data showing that the lowest expected failure rate for that method is less than 1% per year.
- •Subject taking oral contraceptives should have been on a stable regimen for at least 2 months prior to screening
- •4.History of another neoplastic disease. The exceptions are:
- •·non-melanoma skin cancer
- •·carcinoma in situ of any site
- •·any other cancer curatively treated and no evidence of disease for at least 10 years.
- •5.Known symptomatic cerebral or leptomeningeal involvement.
- •6.Other relevant diseases or adverse clinical conditions:
- •·Congestive heart failure or angina pectoris, myocardial infarction within 12 months before inclusion in the study.
- •·Uncontrolled arterial hypertension (i.e. current arterial diastolic blood pressure over 100 mmHg)
- •·Uncontrolled cardiac supraventricular arrhythmias (i.e. requiring a change in medication within the last 3 months or a hospital admission within the past 6 months).
- •·Cardiac ventricular arrhythmia.
- •·History of significant neurological or psychiatric disorders
- •·Active infection.
- •·Myopathy or any clinical situation that causes significant and persistent elevation of CK (>2.5 ULN in two different determinations performed with one week appart)
- •·Significant non-neoplastic liver disease (e.g., cirrhosis, active chronic hepatitis)
- •·Limitation of the patient’s ability to comply with the treatment or follow-up protocol.
- •·Uncontrolled endocrine diseases (e.g. diabetes mellitus, hypothyroidism or hyperthyroidism) (i.e. requiring relevant changes in medication within the last month, or hospital admission within the last 3 months)
- •7.Treatment with any investigational product in the 30 days period before inclusion in the study.
- •8.Known hypersensitivity to Aplidin®, mannitol, cremophor EL, or ethanol
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