jRCTs031210040已完成不适用
Phase 1/2 study of Onivyde, nanoliposomal-irinotecan plus S-1 in metastatic or recurrent pancreatic cancer after first-line gemcitabine-based therapy (Phoenix study)
未提供0 个研究点目标入组 68 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 80age old under（—）
- 性别
- All
入选标准
- •(1) Histologically or cytologically confirmed adenocarcinoma;
- •(2) Metastatic or recurrent* pancreatic cancer diagnosed by contrast-enhanced CT(chest,abdomen,and pelvis) and / or MRI(abdomen and pelvis) imaging;
- •If the patient received adjuvant chemotherapy and the diasese recurred within 6 manths after the completion,the patient is excluded from this study.
- •(3) Age of 20-80 years at time of enrollment;
- •(4) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- •(5) Metastatic of recurrent pancreatic cancer refractory to first-line gemcitabin-based chemotherapy;
- •(6) Recovery of any toxicities by prior treatment except alopecia to grade 1 or less;
- •(7) Adequate oral intake;
- •(8) Adequate hematologic and organ function defined by the following laboratory test results,obtained within 7days prior to study enrollment;
- •Absolute neutrophil count (ANC) >- 1,500/mm3,
- •Hemoglobin >- 9.0g/dL,
- •Platelet count >- 100,000/mm3,
- •Serum total bilirubin <- 2.0mg/dL,
- •Aspartate transaminase (AST) <- 2.5 x upper limit of normal (ULN) without liver metastases (<-5 x ULN is acceptable if liver metastases are present),
- •Alanine transminase (ALT) <-2.5 x ULN without liver metastases (<-5 x ULN is acceptable if liver metastases are present).
- •Serum albmin >-3.0 g/ dL,
- •Creatinine clearance (CCr) >-50mL/min
- •(9) Signed written informed concsent form
排除标准
- •(1) Prior exposure to irinotecan or fluropyrimidine*;
- •Ajuvant chemotherapy with irinotecan and/or fluorouracil is permitted.
- •(2) History of malignancy (except for adequately treated carcinoma in situ, non-invasive cancer) within 2 years prior to study entry except if the patient has undergone potentially curative therapy with no evidence of that disease recurrence for 2 years;
- •(3) Evidence of uncontrolled,active infection,requiring anti-infectious treatment,except for viral hepatitis;
- •(4) Any chemotherapy for pancreatic cancer within 14days prior to the initiation of study treatment;
- •(5) Any major surgery*,radiotherapy, immunotherapy,or investigational drugs within 28 days prior to the initiation of study treatment;*In cases with exploratory laparotomy,intestinal bypass surgery,billiary bypass surgery ,or endoscopic resection, study entry is permitted if 14 days have passed.
- •(6) Suspected or known central nervous system (CNS) metastases (imaging required only if participants are symptomatic);
- •(7) Symptomatic ascites or pleural effusion;
- •(8) Significant lung disease,including interstitial lung disease,pulmonary fibrosis,or severe emphysema;
- •(9) Active watery diarrhea;
- •(10) Pregnant, lactating or females of childbearing age unless using highly effective contraception;
- •(11) Male with partner of child-bearing potential unless using highly effective contraception;
- •(12) Patients with significant psychiatric disorder;
- •(13) Significant comorbidities,such as uncontrolled diabetes mellitus, uncontrolled hypertension, New York Heart Association (NYHA) Class III or greater cardiac disease, chronic kidney disease, or liver dysfunction;
- •(14) Treatment with the following medications:
- •Systemic immunosuppressive medication, including corticosteroids, and immunosuppressant,
- •Flucytosine,
- •Phenytoin,
- •Warfarin,
- •Rifampicin,
- •Atazanavir sulfate,
- •(15) History of hypersensitivity to the following agents:
- •Irinotecan,
- •Fluoropyrimidines,
- •Any of the components/excipients of nanoliposomal-irinotecan (nal-IRI) and S1, or other liposomal products,
- •(16) Cannnot stop medications that are potent CYP3A4 inducers within 2 weeks and inhibitors within 1 week before start of study treatment.
- •(17) Patients whose entry in the study is considered by the investigator to be inappropriate;
- •(18) History of arterial thromboembolism (e.g., myocardial infarction, unstable angina,and cerebral
- •infarction) within 6 months prior to the initiation of study treatment,
- •(19) Presence of a UGT1A1 genetic polymorphism (UGT1A1*6/*6, UGT1A1*28/*28, or UGT1A1*6/*28 ;
- •phase 1 only)
结局指标
主要结局
-
Phase 1 part : frequency of dose-limiting toxicities (DLTs) Phase 2 part : overall survival
次要结局
未报告次要终点
研究者
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