EUCTR2013-004101-75-BE进行中（未招募）1 期
Randomized crossover trial to assess the effects and quality of life in patients with locally advanced or metastatic pancreatic cancer treated with gemcitabine in combination with nab-paclitaxel: QOLINPAC - QOLINPAC
Z Leuven0 个研究点目标入组 146 人开始时间: 2014年1月28日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 146
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
入选标准
- •1.Written informed consent (+ optional for TR) must be given according to ICH/GCP and national/local regulations.
- •2.Patient is at least 18 years of age.
- •3.Unresectable locally advanced or metastatic pancreatic cancer.
- •4.Histologically or cytologically confirmed adenocarcinoma of the pancreas. Islet cell neoplasms and neuroendocrine tumours are excluded..
- •5.Evaluable or measurable disease, not in a previously irradiated area.
- •6.Life expectancy of at least 12 weeks.
- •7.WHO ECOG performance status = 2
- •8.Adequate organ function.
- •9.Adequate bone marrow, hepatic and renal function.
- •10.Acceptable coagulation determined on routine tests (e.g. prothrombin time, partial thromboplastin time, INR, etc, within +/- 15% of normal limits or as per clinical practice).
- •11.No clinically significant abnormalities in urinalysis.
- •12.Effective contraception for both male and female patients if applicable. Women of childbearing potential must have negative blood pregnancy test at screening visit.
- •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 58
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 85
排除标准
- •1.Prior chemotherapy, surgery or other investigational therapy for the treatment for metastatic disease. Adjuvant treatment with gemcitabine or 5-FU is allowed provided at least 6 months have elapsed since completion of the last dose.
- •2.Major surgery within 4 weeks of the start of the study.
- •3.Irradiation within 3 weeks prior to study entry.
- •4.Brain metastasis (known or suspected).
- •5.Serious medical risk factors involving any of the major organ systems, including high cardiovascular risk including coronary stenting or myocardial infarction in the last year and psychiatric disorders.
- •6.Known infection with HIV or active infection with hepatitis B or C.
- •7.History of connective tissue disorders (eg. lupus, scleroderma, arteritis nodosa, etc).
- •8.History of interstitial lung disease.
- •9.History of peripheral artery disease.
- •10.Previous (within 5 years) or concurrent malignancies at other sites with the exception of surgically cured or adequately treated carcinoma in-situ of the cervix and basal cell carcinoma of the skin.
- •11.Known allergy or any other adverse reaction to any of the drugs or to any related compound.
- •12.Use of oral anticoagulants that interfere with the metabolic path of nab-Paclitaxel (cytochrome P450 isoenzymes CYP2C8 and CYP3A4) such as warfarin (Coumadin), rivaroxaban (Xarelto), etc, and the impossibility to switch anticoagulation treatment to low molecular weight heparin.
- •13.Organ allografts requiring immunosuppressive therapy.
- •14.Pregnancy or breast-feeding.
- •15.Medical, social or psychological condition which, in the opinion of the investigator, would not permit the patient to complete the study or sign meaningful informed consent.
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