A Study of ARQ 197 Versus Investigator's Choice of Second-Line Chemotherapy in Patients With Locally Advanced or Metastatic Gastric Cancer Who Have Progressive Neoplastic Disease Following Treatment With One Prior Chemotherapy Regimen

Launched by ARQULE, INC., A SUBSIDIARY OF MERCK SHARP & DOHME LLC, A SUBSIDIARY OF MERCK & CO., INC. (RAHWAY, NJ USA) · Feb 17, 2010

Keywords

ClinConnect Summary

This will be a multi-center, open-label randomized phase 2 study designed to evaluate the PFS of ARQ 197 versus investigator's choice of second-line chemotherapy in patients with unresectable (locally advanced or metastatic) gastric carcinoma who have progressive neoplastic disease following treatment with a prior regimen consisting of at least two of the drugs 5-FU, cisplatin and docetaxel. Patients will be randomized to ARQ 197 arm or investigator's choice arm in a 1:1 ratio. The study will also evaluate other efficacy and safety parameters including ORR, OS and adverse events in the two ...

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Eligibility criteria

• Inclusion Criteria:
• • 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)
• • 6. Eastern Cooperative Oncology Group performance status 0 to 2
• • 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 x ULN
• • 12. Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L
• • 13. Platelets ≥ 100 x 10\^9/L
• Exclusion Criteria:
• • 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 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 capecitabine, 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 protocol defined treatments
• • 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