NCT02155582已完成1 期
A Phase I Pharmacodynamic Study of Copanlisib (BAY 80-6946) as Monotherapy in Patients With Non-Hodgkin's Lymphoma and Solid Tumors
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
- 63
- 主要终点
- Maximum change from baseline in expression of pathway inhibition (pAKT) in surrogate tissue (platelet rich plasma) during copanlisib monotherapy
研究概览
简要总结
This study aims to analyze what the study drug does to the body and its relationship to drug levels and safety after patients with advanced cancer have been treated with copanlisib in different dose groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Previous or concurrent cancer that is distinct in primary site or histology from NHL or the solid tumor, for which the patient is enrolled into this study, within 5 years before treatment start EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer, in situ breast cancer, in situ prostate carcinoma if Gleason score < or equal to 6 and prostate-specific antigen <10 ng/mL, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)]
- •Known lymphomatous involvement of the brain or leptomeningeal involvement; solid tumor patients with central nervous system (CNS) metastases if treatment completed <3 months before enrollment or lesions unstable or progressing on magnetic resonance imaging scans performed within 1 month of enrollment or unstable symptoms of the CNS metastases
- •Any illness or medical condition that is unstable or could jeopardize the safety of the patient or his / her compliance in the study
- •Current diagnosis of type 1 or type 2 diabetes mellitus with HbA1c < or equal to 8.5% or fasting blood glucose < or equal to 160 mg/dL
研究组 & 干预措施
Arm 1
Experimental
0.8 mg/kg body weight and 0.4 mg/kg (not to exceed 65 mg) for the non-diabetic patients
干预措施: Copanlisib (BAY80-6946) (Drug)
Arm 2
Experimental
45 mg and 60 mg for the diabetic patients
干预措施: Copanlisib (BAY80-6946) (Drug)
结局指标
主要结局
Maximum change from baseline in expression of pathway inhibition (pAKT) in surrogate tissue (platelet rich plasma) during copanlisib monotherapy
时间窗: Baseline and approximately 2 years
Maximum change from baseline in plasma glucose during 2 cycles of copanlisib monotherapy
时间窗: Baseline and after day 22
次要结局
- AEs as characterized by type, frequency, severity (as graded by CTCAE) and relationship to study drug(Approximately 2 years)
- Maximum change from baseline in C-peptide during 2 cycles of copanlisib(After day 22)
- Change from baseline in expression and / or phosphorylation of PI3K pathway proteins in paired tumor biopsies(Baseline and after day 22)
- AUC(0-168) of copanlisib after each copanlisib IV infusion during 2 cycles of copanlisib monotherapy(After day 22)
- Maximum change from baseline in insulin during 2 cycles of copanlisib(After day 22)
- FDG PET early response (decreased SUVmax compared to baseline) after dosing with copanlisib for non-diabetic patients with detectable FDG tumor uptake at baseline(After day 22)
研究者
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