A Phase 1a/1b Study of SUN-101 in Subjects with Pancreatic Ductal Adenocarcinoma Previously Treated with Gemcitabine or FOLFIRINOX

Sun BioPharma Australia Pty Ltd0 个研究点目标入组 42 人开始时间: 2013年9月5日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•1. Histologically or cytologically confirmed metastatic or locally advanced ductal adenocarcinoma of the pancreas with CT scan measurable disease by RECIST criteria.
•2. ECOG Performance Status 0 or 1
•3. Received one, and only one, line of systemic therapy for their pancreatic locally advanced or metastatic pancreatic adenocarcinoma, including either: gemcitabine (with or without Abraxane, or another agent) or FOLFIRINOX or prior investigator-modified FOLFIRINOX regimen.
•4. Adult, age greater than or equal to 18, male or female
•5. Females of child-bearing potential must use investigator-approved method of contraception. All sexually active males must also use an investigator approved method of contraception.
•6. Adequate bone marrow, hepatic, renal and coagulation function:
•7. Adequate renal function, with calculated creatinine clearance greater than 50 mL/min using the Cockcroft and Gault equation
•8. Willing and able to provide written informed consent

•1. Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the subject to participate in the study or which would jeopardize compliance with the protocol
•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 tumour or mixed adenocarcinoma-neuroendocrine carcinoma
•4. Have symptomatic central nervous system (CNS) malignancy or metastasis.
•5. Serum albumin levels less than 30 g/L
•6. Life expectancy less than 12 weeks
•7. Presence of known active bacterial, fungal, or viral infection requiring systemic therapy
•8. Known infection with HIV, hepatitis B or C
•9. Presence of congestive heart failure or symptomatic coronary artery disease, interstitial lung disease, pulmonary fibrosis, or pulmonary hypersensitivity reaction
•10. Lack of physical integrity of the upper gastrointestinal tract
•11. Malabsorption syndrome pre-dating the diagnosis of pancreatic cancer.
•12. Known, existing coagulopathy or receiving anticoagulants
•13. Pregnant or lactating
•14. Major surgery within 4 weeks of the start of study treatment, without complete recovery
•15. Participation in any other clinical investigation within 4 weeks of enrolment

发起方

Sun BioPharma Australia Pty Ltd