2025-522355-26-00
尚未招募
2 期
A Rollover Study of Sotorasib with or without Panitumumab for the Treatment of Cancer Subjects with KRAS p.G12C Mutation Previously Treated in an Amgen-Sponsored Study.
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Amgen Inc.
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Incidence and severity of treatment-emergent adverse events, clinically significant changes in vital signs, and clinical laboratory tests
概览
简要总结
To evaluate the safety and tolerability of the continuation of sotorasib with or without panitumumab and/or other anti-cancer therapies in participants continuing to derive benefit in Amgen-sponsored studies.
研究设计
- 分配方式
- Non-randomized
- 主要目的
- International Roll-over study
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age greater than 18 years
- •Life expectancy greater than 3 months in the opinion of the investigator
- •Ability to take oral medications and willing to record daily adherence to sotorasib through the use of a written diary
- •Participant is currently receiving treatment with sotorasib alone or in combination therapy in an Amgen-sponsored trial that has met its endpoints or otherwise will be stopping (also referred to as parent study) and are continuing to receive clinical benefit in the opinion of the investigator
- •For a participant in combination therapy in their parent study, treatment with other anti-cancer therapies is allowed provided it matches the parent study
- •Eastern Cooperative Oncology Group Performance Status of greater than or equal to 2
排除标准
- •Participant had permanently discontinued from sotorasib study treatment in the parent study before the parent study's completion
- •Male participants with a female partner of chldbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 7 days after the last dose of sotorasib
- •Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 7 days after the last dose of sotorasib
- •Male participants unwilling to abstain from donating sperm during treatment and for an additional 7 days after the last dose of sotorasib
- •Ongoing, unresolved toxicity requiring interruption of sotorasib treatment at the time of the termination of the parent study
- •Local access to commercially available investigational product(s) at no cost to the participant as permitted by local/country regulation
- •Anticipated toxicities of sotorasib study treatment outweigh the clinical benefit to the participant in the option of the investigator
- •Participant unlikely to be able to complete all protocol-required procedures, restrictions and requirements, in the judgement of the individual and the investigator
- •Significant uncontrolled concomitant disease that could affect compliance with protocol procedures or interpretation of results or that pose a risk to particiant safety, in the opinion of the investigator
- •Female participants of childbearing potential unwilling to use protocol-specified method of contraception during treatment for an additional 7 days after the last dose of sotorasib and 2 months after the last dose of panitumumab
结局指标
主要结局
Incidence and severity of treatment-emergent adverse events, clinically significant changes in vital signs, and clinical laboratory tests
Incidence and severity of treatment-emergent adverse events, clinically significant changes in vital signs, and clinical laboratory tests
次要结局
未报告次要终点
研究者
Medical Information
Scientific
Amgen Inc.
研究点 (2)
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