A Randomized Phase 2 Study of ARQ 197 versus Gemcitabine in Treatment-naïve Patients with Unresectable Locally Advanced or Metastatic Pancreatic Adenocarcinoma

ArQule Inc.0 个研究点目标入组 72 人开始时间: 2007年9月12日最近更新: 2012年3月19日

研究概览

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•Each patient must meet the following criteria to be enrolled in this study.
•1. Able to provide signed and dated informed consent prior to study-specific screening procedures
•2. = 18 years old
•3. Histologically or cytologically confirmed locally advanced or metastatic unresectable pancreatic adenocarcinoma
•4. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST, see Section 9)
•5. Karnofsky performance status (KPS) = 70% (see Appendix 2)
•6. Male or female patients of child-producing potential must agree to use double barrier contraception, oral contraceptives or avoidance of pregnancy measures during the study and for 90 days after the last day of treatment
•7. Females of childbearing potential must have a negative serum pregnancy test
•8. Aspartate transaminase (AST) and alanine transaminase (ALT) = 2.5 × upper limit of normal (ULN) or = 5 × ULN with metastatic liver disease
•9. Hemoglobin = 10 g/dl
•10. Total bilirubin = 1.5 × ULN
•11. Serum creatinine = 1.5 × ULN
•12. Absolute neutrophil count (ANC) = 1.5 x 109/L
•13. Platelets = 100 x 109/L
•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

•Patients who meet any of the following criteria will be excluded from the study.
•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. Central nervous system metastases
•3. Pregnant or breastfeeding
•4. Significant gastrointestinal disorder, in the opinion of the Principal Investigator (e.g. Crohn’s disease, ulcerative colitis, extensive gastric resection)
•5. Unable or unwilling to swallow ARQ 197 capsules twice daily
•6. Other cancer within the last five years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin
•7. Significant co-morbid conditions that in the opinion of the Investigator would impair study participation
•8. Known human immunodeficiency virus (HIV) or hepatitis C virus (HCV) infection

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