EUCTR2005-000051-15-DE进行中（未招募）1 期
Continuing Access to the Tyrosine Kinase Inhibitor of VEGFR-2, AG-013736 (A406) for Patients Previously Receiving AG-013736 in Clinical Trials
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
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
- •Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
- •- Patients who were assigned to an AG-013736-containing treatment arm in a previous clinical trial
- •- Patients who were receiving AG-013736 tablets at the time their previous trial ended
- •- Patients who have stable (SD) or responding disease (PR or CR) documented by the appropriate radiological, clinical, or laboratory assessments within 12 weeks before enrollment (Note: response criteria from the previous AG-013736 protocol should be used to determine stable or responding disease)
- •- Patients who have progeressive disease (PD), but continue to derive clinical benefit from the treatment with AG-013736 in the investigator's opinion, provided that the sum of diameters (SOD) of measurable lesions are still smaller compared to that at baseline and Pfizer clinician has approved the enrollment.
- •- Patients who are informed of, and willing and able to comply with the investigational nature of the trial, and have signed a written informed consent in accordance with institutional and ICH GCP guidelines
- •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
- •Subjects presenting with any of the following will not be included in the trial:
- •- Patients may not participate in this trial if the conditions for continuing treatment in the previous AG-013736 protocol are not met.
研究者
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