NCT00962611已完成1 期
An Open Label Phase I Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Maximum Tolerated Dose and Biomarker Response After Intravenous Administration of Weekly BAY80-6946 to Patients With Advanced Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 57
- 主要终点
- Characterize safety, tolerability + pharmacokinetics, to determine the maximum tolerated dose of BAY80-6946 administered 1x weekly for 3 weeks, every 4weeks, as a 1h-intravenous infusion. Evaluate biomarkers that may be predictive of tumor response.
研究概览
简要总结
The purpose of this study is to determine the tolerability, maximum tolerated dose and pharmacokinetics of this drug.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >/= 18 years.
- •Histological or cytological documentation of non-hematologic, malignant solid tumor, excluding primary brain or spinal tumors, or history of central nervous system metastases
- •At least one measurable lesion or evaluable disease
- •Life expectancy of at least 12 weeks
- •ECOG Performance Status of 0, 1 or 2
- •PT-INR/PTT < 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists]. Low-dose aspirin is permitted (</= 100 mg daily).
- •Adequate bone marrow, liver and renal function
- •Ability to understand and to sign an informed consent form; a signed informed consent must be obtained prior to any study specific procedures
排除标准
- •History of cardiac disease congestive heart failure (CHF) > NYHA Class II; active coronary artery disease, myocardial infarction within 6 months prior to study entry; new onset angina within 3 months prior to study entry or unstable angina or cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or Digoxin are permitted).
- •Current diagnosis of type I or II diabetes mellitus or fasting blood glucose level >125 mg/dL at screening, or HbA1c 7%
- •Active clinically serious infections > Grade 2 (NCI-CTCAE Version 3.0)
- •History of having received allogeneic organ transplant
- •Uncontrolled seizure disorder. Use of cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine or phenobarbital) is not allowed throughout the entire study.
- •Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management
研究组 & 干预措施
Copanlisib
Experimental
干预措施: Copanlisib (Aliqopa, BAY80-6946) (Drug)
结局指标
主要结局
Characterize safety, tolerability + pharmacokinetics, to determine the maximum tolerated dose of BAY80-6946 administered 1x weekly for 3 weeks, every 4weeks, as a 1h-intravenous infusion. Evaluate biomarkers that may be predictive of tumor response.
时间窗: 2 years
次要结局
- Evaluate for early signs of efficacy in expansion cohorts(2 years)
- Determine the effects of BAY80-6946 on blood glucose and insulin, and its safety in patients with type I or II diabetes.(2 years)
研究者
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