ACTRN12615000606583终止1 期
A Phase 1a/1b Study of SBP-101 in Previously Treated Subjects with Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma
Sun BioPharma Australia Pty Ltd0 个研究点目标入组 54 人开始时间: 2015年6月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 54
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
- •1. Histologically or cytologically confirmed locally advanced or
- •metastatic pancreatic ductal adenocarcinoma. Patients with acinar cell carcinoma may also be included.
- •2. Measurable disease on computed tomography (CT) or magnetic resonance imaging (MRI) scan by RECIST criteria (Phase 1b only)
- •3. ECOG Performance Status 0 or 1.
- •4. Received, and failed or were intolerant to at least 1 prior systemic therapy for locally advanced or metastatic pancreatic ductal adenocarcinoma
- •5. Adult, aged 18 years or older, male or female
- •6. Females of child-bearing potential must have a negative serum pregnancy test within 14 days prior to start of study treatment and must use an adequate method of contraception during the study. All sexually active males must also use an adequate method of contraception during the study
- •7. Adequate bone marrow, hepatic, renal and coagulation function
- •8. QTc interval less than or equal to 470 msec at Baseline
- •9. Willing and able to provide written informed consent.
排除标准
- •1. Evidence of severe or uncontrolled systemic disease or any
- •concurrent condition that, in the opinion of the Investigator or
- •Medical Monitor, makes it undesirable for the subject to participate in the study or that would jeopardize compliance with the protocol. Subjects with pre-existing well-controlled diabetes are not excluded.
- •2. Medical or psychiatric conditions that compromise the subject's ability to give informed consent or to complete the protocol or a history of non-compliance
- •3. Presence of islet-cell or pancreatic neuroendocrine tumor or mixed adenocarcinoma-neuroendocrine carcinoma
- •4. Symptomatic central nervous system (CNS) malignancy or metastasis. Screening of asymptomatic subjects without history of CNS metastases is not required.
- •5. Serum albumin less than 30 g/L (3.0 g/dL)
- •6. Glycosylated hemoglobin (Hgb A1C) greater than 8.0%
- •7. Life expectancy less than 16 weeks
- •8. Presence of known active bacterial, fungal, or viral infection
- •requiring systemic therapy
- •9. Known infection with human immunodeficiency virus (HIV),
- •hepatitis B or C
- •10. Presence of interstitial lung disease, pulmonary fibrosis, or
- •pulmonary hypersensitivity reaction
- •11. Myocardial infarction within the last 12 months, severe/unstable angina, symptomatic congestive heart failure New York Heart Association (NYHA) class III or IV
- •12. Maldigestion/malabsorption syndrome pre-dating the diagnosis of pancreatic cancer
- •13. Known existing coagulopathy or receiving anticoagulants
- •14. Pregnant or lactating
- •15. Major surgery within 4 weeks of the start of study treatment, without complete recovery
- •16. Participation in any other clinical investigation within 4 weeks of receiving the first dose of study drug.
研究者
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