EUCTR2008-006302-42-GB进行中（未招募）不适用
A Phase II study in patients with locally advanced pancreatic carcinoma:ARC-II – Akt-inhibition by Nelfinavir plus chemoradiation with gemcitabine and cisplatin - ARC-II in locally advanced pancreatic carcinoma
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
- 49
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
- •1.Histologically or cytologically proven, pancreatic adenocarcinoma or ampullary adenocarcinoma or intrapancreatic bile duct adenocarcinoma
- •2.Patients with locally advanced disease deemed suitable for CRT by the local Multidisciplinary team (MDT) OR patients with resectable cancer of the pancreas who are inoperable due to comorbidity.
- •3.Age >18 years
- •4.Karnofsky Performance Index = 70 %
- •5.At least one measurable tumour lesion (according to RECIST)
- •6.Adequate bone marrow reserve (WBC = 3.0 x 109/l; platelets = 100 x 109/l)
- •7.Written informed consent
- •8.Patient able and willing to comply with all protocol requirements.
- •9.Estimated life expectancy = 12 weeks
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Primary resectable cancer of the pancreas
- •2.Distant metastases other than para-aortic lymphadenopathy
- •3.History of other active invasive malignancy within the past 2 years (excluding non-melanoma skin cancer and in situ carcinoma of the cervix).
- •4.Previous abdominal radiotherapy.
- •5.Renal insufficiency (creatinine clearance <60 mL/min).
- •6.Liver impairment (Bilirubin = 3 x upper limit of normal, ALT or AST and Alkaline Phosphatase =2.5 x upper limit of normal). If patients with recent biliary stent insertion are initially ineligible due to abnormal LFTs, repeated assessments may be indicated to allow inclusion of these patients as their LFTs are likely to improve with time.
- •7.Known haemophilia A and B, chronic hepatitis type B or C.
- •8.Pregnancy or breast feeding patients. Inadequate or unreliable contraceptive measures during participation in the trial. Contraceptives that contain norethisterone and ethinylestradiol must be replaced by other contraceptive methods.
- •9.Other experimental treatment = six weeks prior to registration into this study (including chemothera¬py and immunotherapy).
- •10.Concurrent use of contraindicated drugs that cannot be substituted or discontinued during study treatment.
- •11.Known hypersensitivity to nelfinavir or any of its excipients.
- •12.Major systemic or psychiatric co-morbidities or any other considerations that the Principal Investigator judges might impact on patient safety or protocol compliance and achievement of the study aims.
研究者
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