ACTRN12618000804280进行中（未招募）1 期
A Phase 1 Clinical Trial of CEND-1 in Combination With Nabpaclitaxel and Gemcitabine in Metastatic Exocrine Pancreatic Cancer
DrugCendR Australia Pty Ltd0 个研究点目标入组 30 人开始时间: 2018年5月11日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Patients with histologically confirmed metastatic pancreatic ductal carcinoma
- •One or more metastatic lesions measurable on MRI, PET/CT, or dedicated CT scan according to RECIST v1.1.
- •Eligible for treatment with nabpaclitaxel and gemcitabine
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •Life expectancy of at least 3 months
- •Adequate archival tissue from prior biopsy for biomarker evaluation or willingness to undergo biopsy before treatment starts
- •The patient is capable of understanding and complying with the protocol and the subject or, when applicable, the subject's legally acceptable representative has signed the informed consent
- •A negative serum pregnancy test (if a premenopausal female patient)
- •Acceptable liver function: Bilirubin equal or less than 1.5 times upper limit of normal; AST (SGOT) less than 10 times upper limit of normal, ALT (SGPT) and Alkaline phosphatase equal or less than 2.5 times upper limit of normal (if liver metastases are present, then equal or less than 5 times upper limit is allowed).
- •Acceptable renal function: Serum creatinine within normal limits AND calculated creatinine clearance equal or more than 60 mL/min/1.73 per square meter for patients with creatinine levels above institutional normal by the Cockroft-Gault equation.
- •Acceptable hematologic status: Granulocyte equal or more than 1500 cells/mm3; Platelet count equal or more than 100,000 plt per square millimetre; Hemoglobin equal or more than 9 g/dL.
- •Urinalysis: No clinically significant abnormalities.
- •Acceptable coagulation status: PT within normal limits; PTT within normal limits.
- •For men and women of child-producing potential, the use of effective contraceptive methods during the study.
排除标准
- •New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG
- •Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
- •Pregnant or nursing women. Women of child-bearing potential and men must agree to use adequate contraception.
- •Unwillingness or inability to comply with procedures required in this protocol
- •Known infection with HIV, hepatitis B, or hepatitis C
- •Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions per physician judgement) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
研究者
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