EUCTR2018-003585-14-DE进行中（未招募）1 期
An open-label, randomised, multicentre, phase III study of irinotecan liposome injection, oxaliplatin, 5-fluorouracil/leucovorin versus nab-paclitaxel plus gemcitabine in subjects who have not previously received chemotherapy for metastatic adenocarcinoma of the pancreas - Napoli 3
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 770
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)Subject has been informed about the nature of the study, and has agreed to participate in the study, and signed the ICF prior to participation in any study-related activities.
- •(2)Male or non-pregnant and non-lactating female and =18 years of age:
- •(a)Females of child-bearing potential (i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy) must test negative for pregnancy at the time of screening based on a urine or serum pregnancy test. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. Female subjects of reproductive potential must agree to use a highly effective method of birth control, during the study and for 7 months following the last dose of study medication (see also Appendix 4).
- •(b)Male subjects must agree to use condoms during the study and for 6 months following the last dose of study medication.
- •(3)Histological or cytologically confirmed adenocarcinoma of the pancreas that has not been previously treated in the metastatic setting.
- •(4)Initial diagnosis of metastatic disease must have occurred =6 weeks prior to screening.
- •(5)Subject has one or more metastatic tumours measurable by CT scan (or MRI, if the subject is allergic to CT contrast media) according to RECIST Version 1.1 criteria.
- •(6)Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening and within 7 days prior to randomisation.
- •(7)Subject has adequate biological parameters as demonstrated by the following blood counts:
- •(a)Absolute neutrophil count (ANC) =2000/mm3 without the use of hemopoietic growth factors within the last 7 days prior to randomisation
- •(b)Platelet count =100,000/mm3
- •(c)Haemoglobin (Hgb) =9 g/dL obtained =14 days prior to randomisation.
- •(8)Adequate hepatic function as evidenced by:
- •(a)Serum total bilirubin =1.5x upper limit of normal (ULN) (biliary drainage is allowed for biliary obstruction), and
- •(b)Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =2.5x ULN (=5x ULN is acceptable if liver metastases are present).
- •(9)Adequate renal function with a creatinine clearance (CLCR) of >30 mL/min. Actual body weight should be used for calculating CLCR using the Cockcroft Gault Equation:
- •CLCR (mL/min) = ((140–Age [years]) * (Weight [kg]/(Serum Creatinine [mg/dL]*72).
- •Multiply the result by 0.85 if the subject is female. For subjects with a body mass index (BMI) >30 kg/m2, adjusted body weight should be used instead.
- •(10)Electrocardiogram (ECG) without any clinically significant findings (QT interval corrected by Fridericia’s formula (QTcF) < or = 450 msec and no known arrhythmias), and per the investigator’s assessment.
- •(11)Adequate coagulation studies (obtained =14 days prior to randomisation) as demonstrated by prothrombin time and partial thromboplastin time within normal limits (=1.5 x ULN). (Subjects on warfarin or other vitamin K antagonists should be discussed wit
排除标准
- •(1)Any other medical or social condition deemed by the investigator to be likely to interfere with a subject's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
- •(2)Unwilling or unable to comply with study procedures and/or study visits.
- •(3)Prior treatment of pancreatic cancer in the metastatic setting with surgery, radiotherapy, chemotherapy or investigational therapy:
- •(a)Palliative radiotherapy is permitted
- •(b)Placement of biliary stent/tube is permitted.
- •(4)Prior treatment of pancreatic adenocarcinoma with chemotherapy in the adjuvant setting, except those where at least 12 months have elapsed since completion of the last dose and no persistent treatmentrelated toxicities are present.
- •(5)Subject has only localised advanced disease.
- •(6)Documented serum albumin <3 g/dL within 7 days prior to randomisation.
- •(7)Known history of central nervous system (CNS) metastases. (Subjects on a stable or decreasing dose of steroids and deemed clinically stable as per the investigator's assessment are eligible).
- •(8)Clinically significant gastrointestinal disorder including hepatic disorders, bleeding, inflammation, occlusion, diarrhoea >Grade 1, malabsorption syndrome, ulcerative colitis, inflammatory bowel disease or partial bowel obstruction.
- •(9)History of any second malignancy in the last 2 years; subjects with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Subjects with a history of other malignancies are eligible if they have been continuously disease free for at least 2 years prior to screening. Subjects who have a concurrent malignancy that is clinically Stable and does not require tumour-directed treatment are eligible.
- •(10)Known hypersensitivity to any of the components of irinotecan liposome injection, other liposomal products, or any components of 5FU, LV or oxaliplatin.
- •(11)Known hypersensitivity to any of the components of nab-paclitaxel or gemcitabine.
- •(12)Concurrent illnesses that would be a relative contraindication to trial participation such as active cardiac or liver disease, including:
- •(a)Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) less than 6 months before screening
- •(b)High cardiovascular risk, including, but not limited to, recent coronary stenting or myocardial infarction in the past year prior to screening
- •(c)New York Heart Association (NYHA) Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure
- •(d)Known historical or active infection with hepatitis B, or active infection with hepatitis C (note that subjects with hepatitis C who have been clinically cured, defined as persistent absence of hepatitis C ribonucleic acid (RNA) detected by polymerase chain reaction (PCR) test in serum 12 weeks after completing antiviral treatment, are eligible for this study)
- •(13)Active infection or an unexplained fever >38.5°C during screening visits or on the first scheduled day of dosing (at the discretion of the investigator, subjects with tumour fever may be enroled)
- •(14)Major surgery, other than diagnostic surgery, within 4 weeks prior to randomisation. (15)Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1 (please refer to Appendix 1). Subjects are ineligible if:
- •-they are unable to discontinue the use of strong inhibitors of CYP3A, CYP2C8 and UGT1A1 at least 1 week prior to randomisation
研究者
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