EUCTR2013-004200-19-GB进行中（未招募）1 期
Pancreatic Resectability in Cancers with Known Limited Extension (PRICKLE) - A single-centre phase 2a study of Gemcitabine plus Nab-paclitaxel for borderline unresectable locally advanced pancreatic cancer. - PRICKLE
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge0 个研究点目标入组 9 人开始时间: 2014年6月19日最近更新:
适应症
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
- 9
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
- •Patients are eligible for inclusion in the study if they meet all of the following criteria:
- •Patients with inoperable locally advanced pancreatic adenocarcinoma, defined as Category 2 by central radiological review.
- •Aged 18 years or over at the time of signing the Informed Consent Form.
- •Documented histological or cytological diagnosis of pancreatic ductal adenocarcinoma.
- •ECOG performance status 0-1.
- •Life expectancy of at least 12 weeks.
- •Willing and able to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
- •Adequate haematological function defined by:
- •oAbsolute neutrophil count (ANC) =1,500 cells/mm3 (1.5 x 10 9/L).
- •oHaemoglobin =8.0 g/dL (80 g/L) (may be increased to this level with transfusion as long as there is no evidence of active bleeding).
- •oPlatelets =100 x 10 9/L
- •Adequate renal function defined by serum creatinine =1.5 x ULN or calculated creatinine clearance by Cockcroft-Gault of =50 ml/min.
- •Adequate hepatic function defined by:
- •oAspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =2.5 x upper limit of normal (ULN)
- •oTotal bilirubin =1.5 x ULN
- •Patients may have endoscopic or radiologic stenting to treat biliary obstruction. If so, bilirubin must return to =1.5 x ULN prior to enrolment.
- •Received no prior therapy for their disease.
- •Measurable disease by RECIST 1.1 criteria. Tumour assessments and measurements must be done within 28 days before the patient receives the first dose of ABX/GEM.
- •All Women of Child Bearing Potential (WoCBP), all sexually active male patients, and all partners of patients must agree to use effective contraception methods throughout the study and for six (6) months after the final dose of trial drug.
- •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 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •Patients are to be excluded from the study if they meet any of the following criteria:
- •Patients with metastatic PDAC, or disease which is amenable to resection with curative intent. These include tumours which are defined as Category 1 or 3 by central radiological review.
- •Other invasive malignancies diagnosed within the last 5 years, with the exceptions of adequately treated localized cured prostate cancer, in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for three years or more and are deemed at negligible risk for recurrence, are eligible for the trial.
- •Known allergy or hypersensitivity to ABX or GEM.
- •Routine use of oral anti-oxidant supplements: beta-carotene, selenium, lutein, zeaxanthin, lycopene, pycnogenol, fernblock, omega-3S, vitamin C, vitamin E, astaxanthin. If recent use, a washout period of 5 half-lives is required.
- •Patients with pre-existent ischemic heart disease particularly those under active treatment for coronary disease, will be excluded from Sonuvue dynamic contrast enhanced ultrasound investigation due to sporadic reports of cardiac ischemia in this population. They will be eligible for the rest of the study, as long as their cardiac status does not preclude surgery.
- •Significant acute or chronic medical or psychiatric condition, disease or laboratory abnormality which in the judgment of the Investigator would place the patient at undue risk or interfere with the study. Examples include, but are not limited to:
- •oPatients who have had a venous thromboembolic event (e.g., pulmonary embolism or deep vein thrombosis) requiring anticoagulation who are not appropriately anti-coagulated or have had a NCI CTCAE (version 4.0) Grade 2 or greater bleeding episode in the 4 weeks before Day 1.
- •oPatients taking warfarin, unless it is possible for the patient to be switched to a low molecular weight heparin for the duration of the study
- •oPatients with a significant history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months.
- •oCirrhotic liver disease, ongoing alcohol abuse, or known chronic active or acute hepatitis B, or hepatitis C.
- •oKnown infection with HIV.
- •Women, who are pregnant, plan to become pregnant or are lactating (during the study or for up to 12 months after the last dose).
研究者
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