Long-Term Extension Study for Participants Previously Enrolled in an Exelixis-Sponsored Study
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 发起方
- Exelixis
- 入组人数
- 5,000
- 试验地点
- 2
研究概览
简要总结
The primary objective of this long-term extension study is to allow continued access to study treatment for eligible participants who are deriving clinical benefit in an Exelixis-sponsored study who do not have access to treatment locally.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible to continue receiving the study treatment in the parent study (that is, has not met parent study discontinuation/withdrawal criteria).
- •Continuing to derive clinical benefit from the study treatment at the time of transition from the parent study as assessed by the investigator.
- •Able to comply with the long-term extension study protocol as determined by the investigator.
- •Able to receive the first dose of study treatment in this extension study within the specified treatment interruption window allowed by the parent study.
排除标准
- •Meet any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in this extension study.
- •Study treatment is commercially marketed in the participant's country for the participant-specific disease and is accessible to the participant.
- •Treatment with any anticancer treatment (other than treatment permitted in the parent study) during the time between last treatment in the parent study and the first dose of study treatment in this long-term extension study.
- •Permanent discontinuation of all study treatment(s) for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in this long-term extension study (if applicable).
- •Concurrent participation in any therapeutic clinical trial (other than the parent study).
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Cabozantinib/Zanzalintinib
Depending on the study treatment received in the parent study, participants may receive cabozantinib alone or in combination with other agents; zanzalintinib alone or in combination with other agents, or comparator.
干预措施: Nivolumab (Drug)
Cabozantinib/Zanzalintinib
Depending on the study treatment received in the parent study, participants may receive cabozantinib alone or in combination with other agents; zanzalintinib alone or in combination with other agents, or comparator.
干预措施: Enzalutamide (Drug)
Cabozantinib/Zanzalintinib
Depending on the study treatment received in the parent study, participants may receive cabozantinib alone or in combination with other agents; zanzalintinib alone or in combination with other agents, or comparator.
干预措施: Cabozantinib (Drug)
Cabozantinib/Zanzalintinib
Depending on the study treatment received in the parent study, participants may receive cabozantinib alone or in combination with other agents; zanzalintinib alone or in combination with other agents, or comparator.
干预措施: Abiraterone (Drug)
Cabozantinib/Zanzalintinib
Depending on the study treatment received in the parent study, participants may receive cabozantinib alone or in combination with other agents; zanzalintinib alone or in combination with other agents, or comparator.
干预措施: Prednisone (Drug)
Cabozantinib/Zanzalintinib
Depending on the study treatment received in the parent study, participants may receive cabozantinib alone or in combination with other agents; zanzalintinib alone or in combination with other agents, or comparator.
干预措施: Zanzalintinib (Drug)
Cabozantinib/Zanzalintinib
Depending on the study treatment received in the parent study, participants may receive cabozantinib alone or in combination with other agents; zanzalintinib alone or in combination with other agents, or comparator.
干预措施: Atezolizumab (Drug)