NL-OMON40040招募中不适用
A two parts, biomarker study to identify genetic aberrations predictive for response on Everolimus in solid tumors without regular treatment options (CPCT*03) - CPCT-03
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 80 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
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
- •-Subjects must provide written informed consent prior to performance of study*specific procedures or assessments, and must be willing to comply with treatment and follow*up.
- •- Inclusion in CPCT-02 study
- •- Age >= 18 years
- •- Diagnosis of malignant tumor showing progressive disease according to investigators opinion.
- •- WHO performance status of (0*2)
- •- Measurable disease allowing for volumetric measurements.
- •- No availability of standard of care systemic treatment options or patient refuses to receive standard of care chemotherapy treatment
- •- A female is eligible to enter and participate in this study if she is of: Non*childbearing potential (i.e., physiologically incapable of becoming pregnant) or by using adequate contraception
- •- Adequate organ system function.
排除标准
- •- Previous treatment with mTOR inhibitors/pi3k inhibitors/AKT inhibitors
- •- Uncontrolled hypertension defined as RR > 160/95 mmHg
- •- Serious non*healing wound, ulcer or bone fracture
- •- Within 7 days of surgery (including minor procedures)
- •- Known and/or symptomatic intracerebral metastases
- •- Pregnancy or breast feeding, reproductive potential not using effective birth control methods
- •- Severe medical condition(s) prohibiting participation in the study
- •- Use of other investigational agents now or last 28 days prior to study treatment start
- •- Unable or unwilling to discontinue use of interacting medications or modify the dosing of interacting drugs for at least 14 days or five half*lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study
- •- Less than four weeks after regular treatment/ palliative radiotherapy.
- •- Prolongation of Fridericia corrected QT interval (QTc) > 480 milliseconds (msecs).
- •- Any severe and / or uncontrolled medical conditions such as:
- •1. Unstable angina pectoris, symptomatic congestive heart failure (Class III or IV congestive heart failure, as defined by the New York Heart Association), myocardial infarction <=6 months prior to enrollment, serious uncontrolled cardiac arrhythmia
- •2. Uncontrolled diabetes as defined by fasting serum glucose > 1.5 × ULN
- •3. Acute and chronic, active infectious disorders and nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy
- •4. Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome)
- •5. Significant symptomatic deterioration of lung function.
研究者
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