EUCTR2005-005542-39-IT进行中（未招募）不适用
An open label extended study use of oral CEP-701 in patients with haematologic and non-haematologic malignancies who have participated in a clinical study of CEP-701 - ND
CEPHALON EUROPE0 个研究点目标入组 100 人开始时间: 2006年5月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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
- •The patient participated in a previous clinical study of oral CEP-701 and would benefit by continuing treatment with CEP-701. Patients randomized to chemotherapy alone in study C0701a/204/ON/US may also be included in this study if in the opinion of their physician they might benefit by receiving oral CEP-701 aged 18 years and older written informed consent is obtained The patient has a diagnosis of haematologic or non-haematologic malignancy The patient must be willing and able to comply with study restrictions and to return to the clinic for clinical and follow-up evaluations as specified in this protocol. The patient must enter the study within 30 days of participating in the previous clinical study of CEP-701; or if the patient received chemotherapy after the previous study of CEP-701, within a window of 3 to 14 days after receiving the last dose of chemotherapy women must be neither pregnant nor lactating, and either of non-childbearing potential or using adequate contraception with a negative pregnancy test result at study entry.
- •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
- •active gastrointestinal ulceration or bleeding bilirubin levels greater than 2 times upper limit of normal ULN , alanine transaminase or aspartate transaminase levels greater than 3 times ULN serum creatinine concentrations greater than 2.0 mg/dL The patient has a non-haematological malignancy and one or more of the following abnormal haematologic values - haemoglobin below 9 g/dL - patelets count below 100000/ 956;L - absolute neutrophil counts below 1500 / 956;L The patient requires current treatment for the human immunodeficiency virus with protease inhibitors or requires potent CYP3A4 inhibitors cyclosporine, clotrimazole, fluconazole, itraconazole, voriconazole, ketoconazole, erythromycin, clarithromycin, troleandomycin, and nefazodone
研究者
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