EUCTR2021-001369-19-IT进行中（未招募）1 期
A 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 - Miransertib Extension Study for PROS / PS Patients
MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.0 个研究点目标入组 60 人开始时间: 2021年10月18日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Has PROS or PS and is currently being actively treated with miransertib as part of Study MK-7075-002 (NCT03094832) or ArQule's CU/EAP (NCT03317366)
- •2. Is male or female, from 2 years to 120 years of age, inclusive
- •3. The participant (or legally acceptable representative) has provided documented informed consent/assent for the study. There is no future biomedical research planned for this study
- •4. A WOCBP must have a negative highly sensitive pregnancy test (urine, as required by local regulations) within 72 hours before the first dose of study intervention. If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 6
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Has previously discontinued miransertib due to related SAEs or other intolerance of miransertib
- •2. Other investigational agents, if any, that were administered between leaving Study MK-7075-02 or ArQule's CU/EAP and entering this trial
- •3. Inhibitors of the mTOR pathway (eg, sirolimus, everolimus)
- •4. Immunosuppressive therapies
- •5. Continuous high dose steroids (topical or low dose steroids equivalent to =10 mg prednisone daily are permitted)
研究者
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