NCT06748001招募中4 期
An Open-label, Multicenter, Rollover Study in Patients Who Participated in an Avapritinib Clinical Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 12
- 主要终点
- Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs leading to Discontinuation
研究概览
简要总结
The primary objective of the rollover study is to evaluate the long-term safety of avapritinib in participants who have completed a Blueprint Medicines sponsored study (parent study) and continued to benefit from avapritinib.
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
- •Participated in a Blueprint Medicines sponsored avapritinib clinical study. The Sponsor reserves the right to not roll over patients who have been on drug hold for an extended time period.
- •Completed End of Trial / End of Study (EOT/EOS) visit in the parent study and demonstrated compliance with the parent study requirements.
- •Continue to clinically benefit from treatment with avapritinib.
- •Able to give written informed consent.
- •Agree to continue to use highly effective contraception as defined in this protocol.
- •Female patients of childbearing potential must have negative highly sensitive serum pregnancy test within 20 days before the first dose of avapritinib. Women of nonchildbearing potential do not require this test.
排除标准
- •Participant is participating in another interventional study.
- •Participant is unwilling or unable to comply with study procedures and study restrictions.
- •Participant is breastfeeding.
- •Other protocol-defined criteria apply.
研究组 & 干预措施
Avapritinib
Experimental
Participants who have participated in a Blueprint Medicines sponsored study (the parent study) and continue to benefit from avapritinib.
干预措施: Avapritinib (Drug)
结局指标
主要结局
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs leading to Discontinuation
时间窗: Up to approximately 4 years
次要结局
未报告次要终点
研究者
研究点 (12)
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