EUCTR2010-019588-12-DE进行中（未招募）不适用
A multi-center, phase I/II study of BAY 86-9766 in combination with gemcitabine in patients with locally advanced inoperable or metastatic pancreatic cancer - BAY 86-9766 in combination with gemcitabine in advanced pancreatic cancer
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 93
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female patients =18 years of age
- •Histological or cytologically confirmed locally advanced, inoperable or metastatic pancreatic adenocarcinoma not amenable to curative radiotherapy or surgery
- •Patients must have at least one uni-dimensional measurable lesion by CT or MRI according to RECIST, Version 1.1
- •Resolution of all acute toxic effects of any prior local treatment to CTCAE Grade = 1
- •Eastern Cooperative Oncology Group performance status (ECOG PS) = 2
- •Patient has cardiac function, within normal range, as measured by an echocardiogram
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 28
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 28
排除标准
- •Known history of, or symptomatic metastatic brain or meningeal tumors (head CT or MRI at screening to confirm the absence of central nervous system [CNS] disease if patient has symptoms suggestive or consistent with CNS disease).
- •History of cardiac disease
- •- Congestive heart failure New York Heart Association (NYHA) = Class 2;
- •- Unstable angina (angina symptoms at rest, new-onset angina, ie, within the last 3 months) or myocardial infarction (MI) within the past 6 months prior to start of study treatment
- •- Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted), or uncontrolled hypertension, (systolic blood pressure [BP] >150 mmHg or diastolic blood pressure >90 mmHg despite optimal medical management).
- •Active clinically serious infections (> Grade 2)
- •Clinically significant (ie, symptomatic) peripheral vascular disease
- •Pregnant or lactating women; women of childbearing potential not employing adequate contraception.
- •Use of strong inhibitors of CYP3A4, (eg, ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir, nelfinavir and saquinavir), and strong inducers of CYP3A4 (eg, rifampin)
- •Prior systemic therapy for metastatic or locally advanced, unresectable pancreatic cancer, or other malignant conditions including cytotoxic chemotherapy, targeted agents, or any experimental therapy
- •Previous gemcitabine or 5-fluorouracil (5-FU) given concurrently as radiosensitizers to radiation therapy in adjuvant intention if given within 6 months from start of study treatment
- •Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks) within 6 months prior to start of study treatment
- •History or current evidence of retinal vein occlusion (RVO) or central serous retinopathy (CSR)
- •Visible retinal pathology as assessed by ophthalmologic exam that is considered a risk factor for RVO or CSR
研究者
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