An Open-Label, Phase Ib Study to Assess the Long Term Safety Profile of Pazopanib in Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- To evaluate the long-term safety of repeat daily doses of pazopanib in cancer subjects with solid tumors
研究概览
简要总结
This study was a rollover study to evaluate the long term safety of pazopanib and to continue to provide pazopanib to patients who participated in a GSK sponsored pazopanib study until pazopanib is available commercially.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participated or completed a GSK sponsored pazopanib study and remains eligible for continued treatment with pazopanib and lapatinib (if on combination therapy).
- •Able to understand and provide written informed consent
- •Women and men agree to use protocol specific birth control measures
排除标准
- •The subject has a treatment related serious adverse event that remains unresolved or unstable or had pazopanib permanently stopped in a previous study because of intolerate or because it was unsuccessful in treating your cancer
- •If you are pregnant or breast feeding
- •Your doctor does not think you would be a good candidate for the study
- •Poorly controlled high blood pressure
- •Subject is unwilling or unable to follow the procedures outlined in the protocol.
研究组 & 干预措施
Arm 1
Pazopanib monotherapy or in combination with lapatinib or other approved anti-cancer medications
干预措施: Pazopanib (Drug)
结局指标
主要结局
To evaluate the long-term safety of repeat daily doses of pazopanib in cancer subjects with solid tumors
时间窗: Subjects will stay on the study as long as they are benefiting from treatment, have not met one of the stopping criteria, or experienced a toxicity up to 72 months.
To evaluate the safety assessments; adverse events, vital signs, physical examinations, electrocardiograms, multi-gated acquisition scans or echocardiograms (only for patients on pazopanib and lapatinib combination therapy), and clinical laboratory assessments.
次要结局
未报告次要终点