CTIS2022-500689-87-00进行中（未招募）1 期
Multicenter, Open-label, Phase 2, Extension Trial to Study the Long-term Safety in Participants With PROS or Proteus Syndrome Who Are Currently Being Treated with Miransertib in Other Studies - MK-7075-006
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 65+（—）
- 性别
- All
入选标准
- •Has phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA)-related overgrowth spectrum (PROS) or Proteus Syndrome (PS) and has been screened in Study MK-7075-002 (or has been approved by the Sponsor to screen for MK-7075-002) or is currently being treated with miransertib as part of Study MK-7075-002 (NCT03094832) or ArQule’s CU/EAP (NCT03317366), Is male or female, from 2 to 120 years of age, inclusive, For males, agrees to be abstinent from heterosexual intercourse or use contraception unless confirmed to be azoospermic during the study period and for =90 days after the last dose of study intervention, For females, is not pregnant or breastfeeding, and is either not a woman of childbearing potential (WOCBP) or is a WOCBP and is abstinent or uses a highly effective method of contraception
排除标准
- •Has previously discontinued miransertib due to related SAEs or other intolerance, Has received other investigational agents between leaving Study MK-7075-002 or ArQule’s CU/EAP and entering this study, or mTOR pathway inhibitors, immunosuppressive therapies, or continuous high dose steroids
研究者
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