EUCTR2007-004622-25-LV进行中（未招募）不适用
A Randomized Phase 2 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
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- ArQule Inc.
- 入组人数
- 338
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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