EUCTR2005-000051-15-CZ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 - Continuing Access to AG-013736 (A406) for Patients Previously Receiving AG-013736 in Clinical Trials
Pfizer Inc., 235 East 42nd Streeet, New York, NY 100170 个研究点目标入组 66 人开始时间: 2006年7月27日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 66
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
- •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 Progressive Disease (PD) but have experienced clinical benefit from previous AG-013736 treatment will be eligible for enrollment; in this case, clinical benefit is defined as the Sum of Longest Diameters (SLD) of measurable lesions remaining less than or equal to the baseline SLD in the previous AG-013736 trial. These patients must not be eligible for treatment with other available approved therapy for the disease under study. The Pfizer clinician must approve the enrollment prior to treatment start.
- •- 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 33
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 33
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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