Locally Advanced or Metastatic Gastric Cancer MedDRA version: 9.1 Level: LLT Classification code 10017758 Term: Gastric cancer
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. 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 gastric carcinoma 4. Progressive neoplastic disease despite treatment with a regimen consisting of at least two of the following agents given concurrently: 5-FU, cisplatin and docetaxel OR intolerance to such a regimen 5. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST, see Section 9) 6. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 (see Appendix 5) 7. 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 8. Females of childbearing potential must have a negative serum pregnancy test 9. Aspartate transaminase (AST) and alanine transaminase (ALT) = 2.5 × upper limit of normal (ULN) or = 5 × ULN with known metastatic liver disease 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 more than one prior systemic regimen for the treatment of gastric cancer (including chemotherapy, immunotherapy, vaccines, monoclonal antibodies) 2. Known or suspected central nervous system metastases 3. Pregnant or lactating 4. Significant gastrointestinal disorder that, in the opinion of the Investigator, could interfere with the absorption of ARQ 197 (e.g. Crohn’s disease, ulcerative colitis, extensive gastric resection) 5. Unable or unwilling to swallow ARQ 197 capsules twice daily 6. Any contraindication to treatment with ARQ 197, capecitabine, oxaliplatin or irinotecan 7. Prior treatment with capcecitabine, oxaliplatin or irinotecan 8. Any known hypersensitivity to any of the components of ARQ 197, capecitabine, oxaliplatin or irinotecan 9. Treatment with an investigational agent within 30 days of first dose of ARQ 197 10. Other malignancies within the last five years, with the exception of adequately treated intraepithelial carcinoma of the cervix uteri, prostate carcinoma with a PSA value <0.2 ng/ml or basal or squamous cell carcinoma of the skin 11. Any other significant co-morbid conditions that in the opinion of the Investigator would impair study participation or cooperation 12. Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare the progression-free survival (PFS) of ARQ 197 versus investigator’s choice of second-line chemotherapy in patients with advanced gastric cancer who have failed first-line treatment.;Secondary Objective: •Compare overall response rate (ORR) of ARQ 197 versus investigator’s choice of second-line chemotherapy; •Compare 6-month and 1-year overall survival (OS) rates of ARQ 197 versus investigator’s choice of second-line chemotherapy; •Further characterize the safety profile of ARQ 197; in patients with advanced gastric cancer who have failed first-line treatment.;Primary end point(s): Progression of the disease | — |
Countries
Latvia
Outcome results
None listed