EUCTR2004-002510-11-GB进行中（未招募）不适用
Protocol for the Extended Use of CYC202 for Patients who have previously been enrolled in a Clinical Trial with CYC202 - extension study
Cyclacel Ltd0 个研究点目标入组 20 人开始时间: 2005年8月3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
- 20
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
- •Eligible patients completing the full treatment period with CYC202 in a CYC202 clinical trial with a disease status of at least stable disease at the end of the trial.
- •At least one measurable lesion as defined in the original trial protocol.
- •WHO performance status of 0-2.
- •Life expectancy > 3 months.
- •Adequate clinical pathology values (Blood pathology values as within the inclusion criteria of the first CYC202 trial; Creatinine clearance >= 60ml/min; Bilirubin <= 1.25 x ULN; Alkaline phosphatase, alanine transaminase and aspartate transaminase <= 2.5 x ULN; Prothrombin time within the normal range for the institution).
- •Signed informed consent prior to start of any study specific procedures.
- •Ability to co-operate with treatment and follow-up.
- •Female patients of child-bearing potential must have a negative pregnancy test and use at least one form of contraception as approved by the Investigator for 4 weeks prior to the study and 4 months after.
- •Male patients must use a barrier method of contraception for 4 weeks prior to the study and 4 months after.
- •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
- •Eligible patients completing the full treatment period with CYC202 in a CYC202 clinical trial with a disease status of at least stable disease at the end of the trial.
- •At least one measurable lesion as defined in the original trial protocol.
- •WHO performance status of 0-2.
- •Life expectancy > 3 months.
- •Adequate clinical pathology values (Blood pathology values as within the inclusion criteria of the first CYC202 trial; Creatinine clearance >= 60ml/min; Bilirubin <= 1.25 x ULN; Alkaline phosphatase, alanine transaminase and aspartate transaminase <= 2.5 x ULN; Prothrombin time within the normal range for the institution).
- •Signed informed consent prior to start of any study specific procedures.
- •Ability to co-operate with treatment and follow-up.
- •Female patients of child-bearing potential must have a negative pregnancy test and use at least one form of contraception as approved by the Investigator for 4 weeks prior to the study and 4 months after.
- •Male patients must use a barrier method of contraception for 4 weeks prior to the study and 4 months after.
- •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
- •Patients who, in the opinion of the Investigator, showed poor treatment compliance in the original CYC202 clinical trial; or poor compliance of the study centre during evaluation visits.
- •Patients who withdrew consent during the original CYC202 clinical trial.
- •Any concomitant condition that could compromise the objectives of this study and the patient's compliance.
- •Patients who cannot swallow or patients with chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the tested product.
- •Pregnant or lactating woman.
- •Major thoracic and/or abdominal surgery in the preceding 3 weeks.
- •Known currently active HIV, HBV or HCV infection.
- •Patients who, in the opinion of the Investigator, showed poor treatment compliance in the original CYC202 clinical trial; or poor compliance of the study centre during evaluation visits.
- •Patients who withdrew consent during the original CYC202 clinical trial.
- •Any concomitant condition that could compromise the objectives of this study and the patient's compliance.
- •Patients who cannot swallow or patients with chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the tested product.
- •Pregnant or lactating woman.
- •Major thoracic and/or abdominal surgery in the preceding 3 weeks.
- •Known currently active HIV, HBV or HCV infection.
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