TUCATINIB CONTINUATION PROTOCOL: AN OPEN-LABEL STUDY FOR PARTICIPANTS FROM TUCATINIB CLINICAL STUDIES
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- Pfizer
- 入组人数
- 175
- 主要终点
- To monitor the safety and tolerability of tucatinib
研究概览
简要总结
The purpose of this protocol is to give continued access to tucatinib eligible participants. It also enables ongoing safety follow-up for those who continue to benefit from the study treatment. These participants were part of Pfizer-sponsored tucatinib parent studies that will be closed. Additional follow-up safety information will be collected. This will allow further understanding of the safety profile of tucatinib in participants who continue to receive the study treatment.
详细描述
The study is seeking participants who
- continue to benefit without disease progression from tucatinib as judged by the treating physician.
- are willing to follow protocol requirements. All participants in this study will receive tucatinib. Tucatinib will be taken by mouth 2 times a day. We will examine the experiences of people receiving the study medicine. This will help us assess if tucatinib is safe.
Participants will stay in the study for up to 5 years or until tucatinib is permanently discontinued, whichever comes first. During this time, they will have one clinical visit every three weeks to receive the study treatment. They will also talk with the treating physician about their experiences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Be receiving tucatinib as a study intervention and deriving clinical benefit without evidence of disease progression (as determined by the investigator) in a tucatinib Parent Study.
- •Agree to follow the reproductive criteria.
- •Be willing and able to comply with all scheduled visits, treatment plan, and other study procedures as outlined in this protocol.
- •Be capable of giving signed informed consent.
排除标准
- •Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study.
- •Current use of any prohibited concomitant medications(s) or unwillingness or inability to use a required concomitant medication(s).
- •Participants not previously enrolled or who have discontinued study intervention or who were randomized in the control arm in a Parent Study.
研究组 & 干预措施
tucatinib
150 - 300 mg, by mouth, twice a day
干预措施: tucatinib (Drug)
结局指标
主要结局
To monitor the safety and tolerability of tucatinib
时间窗: Up to approximately 5 years
* Adverse events leading to permanent discontinuation of tucatinib * All serious adverse events
次要结局
未报告次要终点