NL-OMON40404已完成不适用
A Phase 1 Study of Combination Therapy with SAR405838 and Pimasertib in Patients with Advanced Cancer - TCD13388
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
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
- 18 至 99（—）
入选标准
- •Histologically or cytologically confirmed diagnosis of a solid tumor;
- •Presence of locally advanced or metastatic disease with at least one measurable lesion that is not responsive to standard therapies or for which no approved or curative therapy is available.
- •Ability to provide written informed consent. Evidence of a personally signed informed consent;
排除标准
- •Age < 18 years;
- •Eastern Cooperative Oncology Group performance status > 1;
- •Inadequate functions of bone marrow, liver, and kidney;
- •Positive pregnancy test in women of child-bearing potential;
- •Pregnancy or breast-feeding;
- •Extensive prior radiotherapy;
- •The patient has retinal degenerative disease, history of uveitis, or history of retinal vein occlusion, or history of retinal detachment, or has medically relevant abnormalities identified on screening ophthalmologic examination;
- •Prior history of myositis or rhabdomyolysis;
- •Recent major surgery or trauma, unhealing/open wounds;
- •The patient has had congestive heart failure, unstable angina, a myocardial infarction, cardiac conduction abnormality or pacemaker or a stroke within 3 months of entering the study;
- •The patient has a baseline corrected QT interval (QTc) > 480 ms or left ventricular ejection fraction (LVEF) < 50% or less than the lower limit of normal;
- •The patient has a previously-identified allergy or hypersensitivity to components of the study treatment formulations;
- •Unwillingness or inability to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions;
- •Unwillingness, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ an effective barrier or medical method of contraception during the study drug administration and follow-up periods;
- •Recent history of acute pancreatitis;
- •Clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that could affect the safety of the patient; alter the absorption of the study drugs; or impair the assessment of study results;
研究者
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