A Phase 2 Study of ARQ 501 in Combination with Gemcitabine in Adult Patients with Treatment Naive, Unresectable Pancreatic Adenocarcinoma

ARQule Inc.0 个研究点目标入组 75 人开始时间: 2007年1月17日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1. Able to provide signed and dated informed consent prior to study-specific
•screening procedures.
•2. Have a pathologically confirmed diagnosis of unresectable pancreatic adenocarcinoma.
•3. Measurable disease per RECIST.
•4. greater or equal 18 years old.
•5. Karnofsky Performance Status (KPS) of greater or equal 70%.
•6. Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last infusion of ARQ 501.
•7. Hemoglobin (Hgb) greater or equal 10 g/dL.
•8. Absolute neutrophil count (ANC) greater or equal 1.5 × 109/L (greater or equal 1,500/mm3).
•9. Platelet count greater or equal 100 × 109/L (greater or equal 100,000/mm3).
•10. Total bilirubin lower or equal 1.5 × upper limit of normal (ULN) or lower or equal 3.0 × ULN with metastatic liver disease.
•11. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) lower or equal 2.5 × ULN or lower or equal 5.0 × ULN with metastatic liver disease.
•12. Creatinine lower or equal 1.5 × ULN.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. Received any prior therapy for the treatment of their pancreatic malignancy (including chemotherapy, immunotherapy, vaccines, monoclonal antibodies, major surgery, or irradiation, whether conventional or investigational).
•2. Have an active, uncontrolled systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment.
•3. Are pregnant or lactating.
•4. Have a psychiatric disorder(s) that would interfere with consent, study participation, or follow-up.
•5. Symptomatic or untreated central nervous system (CNS) metastases.

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