EUCTR2004-001093-11-GB进行中（未招募）1 期
A Treatment Protocol for Patients Continuing from a Prior SU011248 Protocol
Pfizer Global Research and Development0 个研究点开始时间: 2005年2月23日最近更新:
适应症
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
入选标准
- •Patients must meet all the following inclusion criteria to be eligible for enrollment into the study:
- •1. Patients must have participated in a previous SU011248 protocol, and are judged
- •to have potential to derive clinical benefit from SU011248 treatment by the
- •treating physician.
- •2. Signed and dated informed consent document indicating that the patient (or
- •legally acceptable representative) has been informed of all the pertinent aspects
- •of the trial prior to enrollment.
- •3. Patients must enroll within 4 weeks from their last End of Cycle visit or their End
- •of Treatment/Withdrawal visit in the previous SU011248 study.
- •4. Willingness and ability to comply with scheduled visits, treatment plans and
- •laboratory tests and other study procedures.
- •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
- •The presence of any of the following will exclude a patient from study enrollment:
- •1. Current treatment in another clinical research trial (other than SU011248).
- •2. Symptomatic or uncontrolled CNS metastases.
- •3 Symptomatic congestive heart failure.
- •4. Pregnancy or breastfeeding. Patients must be surgically sterile or be
- •postmenopausal, or must agree to use effective contraception during the period
- •of therapy. The definition of effective contraception will be based on the
- •judgment of the principal investigator or a designated associate
- •5. Other severe acute or chronic medical or psychiatric condition, or laboratory
- •abnormality that may increase the risk associated with study participation or
- •study drug administration, or may interfere with the interpretation of study
- •results, and in the judgment of the investigator would make the patient
- •inappropriate for entry into this study.
研究者
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