Unresectable Locally Advanced or Metastatic Pancreatic Adenocarcinoma MedDRA version: 9.1 Level: LLT Classification code 10033599 Term: Pancreatic adenocarcinoma metastatic
Conditions
Sponsors
ArQule Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate progression-free survival (PFS) in patients receiving ARQ 197 versus gemcitabine. ;Secondary Objective: • Evaluate overall response rate (ORR) in patients receiving ARQ 197 versus gemcitabine. • Evaluate 6-month and 1-year overall survival (OS) rates in patients treated with ARQ197 versus gemcitabine. • Further characterize the safety profile of ARQ 197. ;Primary end point(s): Progression of the disease | — |
Countries
Latvia
Outcome results
None listed