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

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This will be a multi-center, open-label randomized phase 2 study designed to evaluate the progression free survival (PFS) of patients with advanced gastric cancer following treatment with either ARQ 197 or one of three standard regimens (investigator's choice). 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. The study will also evaluate other efficacy and safety parameters including overall response rate, overall survival and adverse events in the two treatment arms.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ArQule; ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)
• Treatments: Capecitabine; Irinotecan; Oxaliplatin

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