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临床试验/NCT01392521
NCT01392521已完成1 期

Phase Ib Trial of the Combination of PI3K Inhibitor BAY 80-6946 and Allosteric-MEK Inhibitor BAY 86-9766 in Subjects With Advanced Cancer

Bayer0 个研究点目标入组 64 人开始时间: 2011年7月最近更新:
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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
64
主要终点
Maximum Tolerated Dose
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The PI3K (phosphoinositol 3-Kinase) inhibitor Copanlisib and the MEK (mitogen-activated protein kinase) inhibitor Refametinib (BAY86-9766)have both been tested as single agent treatments in other phase I studies. This study will test the combination of these two drugs to try and answer the following questions:

  1. What are the side effects of the combination of Copanlisib and Refametinib (BAY86-9766)when given together at different/increasing dose levels?
  2. What dose level of Copanlisib and Refametinib (BAY86-9766) should be tested in future clinical research studies?
  3. How much Copanlisib is in the blood at specific times after administration and does adding Refametinib (BAY86-9766) have an affect?
  4. How much Refametinib (BAY86-9766) is in the blood at specific times after administration and does adding Copanlisib have an affect?
  5. Does the combination of Refametinib (BAY86-9766) and Copanlisib have an effect on tumors?

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 greater than/equal to 18 years old
  • •ECOG Performance Status of 0 - 1
  • •Life expectancy of at least 12 weeks
  • •Patients with advanced, histologically or cytologically confirmed solid tumors, refractory to any standard therapy or have no standard therapy available
  • •LVEF (left ventricular ejection fraction) > or = to the lower limit of normal for the institution
  • •Radiographically or clinically evaluable tumor
  • •Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 14 days prior to start of first dose:
  • •Hemoglobin > 9.0 g/dL
  • •Absolute neutrophil count (ANC) > or = 1500/mm3
  • •Platelet count > or = 100,000 /mm3
  • •Total bilirubin < or = 1.5 times the upper limit of normal
  • •ALT (alanine aminotransferase) and AST (aspartate aminotransferase) < or = 2.5 x upper limit of normal (< or = 5 x upper limit of normal for patients with liver involvement)
  • •PT-INR (prothrombin-international normalized ratio) and PTT (partial thromboplastin time) < or = 1.5 times the upper limit of normal
  • •Serum creatinine < or = 1.5 times the upper limit of normal

排除标准

  • •History of impaired cardiac function or clinically significant cardiac disease (i.e. congestive heart failure (CHF) NYHA (New York Heart Association) Class III or IV); active coronary artery disease, myocardial infarction within 6 months of study entry; new onset or unstable angina within 3 months of study entry, or cardiac arrhythmias requiring anti-arrhythmic therapy
  • •Type 1 or type 2 diabetes mellitus or fasting glucose > 125 mg/dL or HgBA1c > or = 7.0
  • •Use of systemic corticosteroids within 2 weeks of study entry
  • •History of retinal vein occlusion
  • •Known glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • •Active clinically serious infection
  • •Uncontrolled hypertension
  • •Positive for HIV, or chronic Hepatitis B or C
  • •Subjects undergoing renal dialysis
  • •Known bleeding diathesis
  • •Ongoing substance abuse
  • •Pregnant or breast-feeding women

研究组 & 干预措施

Arm 1

Experimental

干预措施: Copanlisib + Refametinib (BAY86-9766) (Drug)

结局指标

主要结局

Maximum Tolerated Dose

时间窗: 2 years

Comparison of the Copanlisib AUC when given alone with the AUC when given with Refametinib (BAY86-9766)

时间窗: At day 15

Comparison of the Refametinib (BAY86-9766) AUC when given alone with the AUC when given with Copanlisib

时间窗: At day 15

次要结局

  • Tumor Response as measured by RECIST 1.1 criteria(3 years)
  • Biomarker evaluation including analysis of pathway activation in blood and plasma(3 years)
  • Pharmacodynamic biomarker evaluation analysis using paired tumor biopsies(3 years)
  • Tumor Response as measured by FDG-PET at MTD and expansion cohort(s)(3 years)

研究者

发起方
Bayer
申办方类型
Industry
责任方
Sponsor

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