EUCTR2005-000666-39-CZ进行中（未招募）不适用
A Controlled, Randomized, Open label Phase II Trial to Evaluate Safety and Efficacy of a 1st line Combination Treatment with Weekly Infusion of Gemcitabine and Twice Weekly Administration of Lipid Complexed Paclitaxel (EndoTAG®-1) in Three Dose Levels Compared with Gemcitabine Monotherapy in Patients with Measurable Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas - N/A
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- MediGene AG
- 入组人数
- 200
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
- •Inclusion Criteria:
- •- Written informed consent
- •- histologically or cytologically confirmed pancreatic adenocarcinoma suitable for chemotherapy
- •- clinical diagnosis of irresectable pancreatic adenocarcinoma
- •- ECOG performance status 0, 1 or 2
- •- = 18 years old
- •- negative pregnancy test (females of childbearing potential)
- •- willingness to perform double-barrier contraception during study and for 6 months post chemotherapy treatment
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Cardiovascular disease, New York Heart Association (NYHA) III or IV
- •- History of severe supraventricular or ventricular arrhythmia
- •- History of coagulation or bleeding disorder (PTT > 1.5 x ULN)
- •- Severe pulmonary obstructive or restrictive disease
- •- Diabetic retinopathy
- •- Acute or chronic inflammation (autoimmune or infectious)
- •- Significant active / unstable non-malignant disease likely to interfere with study assessments
- •- Laboratory tests (hematology, chemistry) outside specified limits:
- •- WBC = 3 x 1000/ mm3
- •- ANC = 1.5 x 1000/mm3
- •- Platelets = 100.000 / mm3
- •- Hb = 9.0 g/dl (= 5.6 mmol/l)
- •- PT/PTT > 1.5 x ULN
- •- Serum creatinine > 2.0 mg/dl (> 176.8 mmol/l)
- •- AST and/or ALT > 5 x ULN
- •- Alkaline phosphatase > 2 x ULN
- •- Total bilirubin > 2 x ULN
- •- Immunotherapy < 6 weeks prior to enrollment
- •- Any chemotherapeutical treatment for pancreatic adenocarcinoma before enrollment
- •- Any radiotherapy for pancreatic adenocarcinoma before enrollment except for treatment of bone metastases if target lesions are not included in the irradiated field
- •- Major surgery < 4 weeks prior to enrollment
- •- Pregnant or nursing
- •- Investigational medicinal product < 4 weeks of enrollment
- •- HIV history
- •- Hypersensitivity to any component of the EndoTAG™-1 and/or gemcitabine formulations
- •- History of significant liver pathology (other than metastases)· History of malignancy other than pancreatic cancer < 5 years prior to enrollment, except skin cancer treated locally
- •- Vulnerable populations (e.g. subjects incapable of giving consent personally
研究者
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