EUCTR2007-004634-17-DE进行中（未招募）不适用
A Randomized Phase 2 Study of Erlotinib plus ARQ 197 versus Erlotinib plus Placebo in Previously Treated Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer
适应症
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
- 193
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
- •2. = 18 years old
- •3. Histologically or cytologically confirmed inoperable locally advanced or metastatic
- •(stage IIIB/IV) NSCLC
- •4. = one prior chemotherapy regimen (including adjuvant chemotherapy)(not to have
- •included erlotinib or other EGFR inhibiting agent)
- •5. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors
- •6. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 (see
- •Appendix 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)
- •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
- •14. Confirmed availability of archival pathology samples (10 unstained paraffinembedded slides) or tissue block suitable for subsequent analysis of K-ras, EGFR, and c-Met
- •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. Previous receipt of erlotinib or other EGFR inhibiting therapy
- •2. Receipt of any anti-tumor treatment for NSCLC within 4 weeks (2 weeks for
- •radiotherapy) prior to the start of designated treatment
- •3. Documented major surgical procedure within 4 weeks prior to randomization.
- •4. Symptomatic central nervous system metastases either considered in the opinion of investigator to be clinically unstable or which require steroids, anti-epileptics, or
- •other symptom-relieving medications
- •5. Pregnant, breast-feeding, or refusing double barrier contraception, oral contraceptives or avoidance of pregnancy measures
- •6. Significant gastrointestinal disorder that, in opinion of Investigator, could interfere
- •with the absorption of ARQ 197 and/or erlotinib (e.g. Crohn’s disease, small or large
- •bowel resection, malabsorbtion syndrome)
- •7. Unable or unwilling to swallow the complete dose of erlotinib or ARQ 197
- •8. Any known contraindication to treatment with ARQ 197 or erlotinib
- •9. Any known hypersensitivity to any of component of ARQ 197 or erlotinib
- •10. Other malignancy within 5 years of randomization, 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. Previously diagnosed grade 3 or 4 (CTCAE) bradycardia or other heart arrhythmia
- •12. Any other significant co-mormid condition that, in opinion of the Investigator, would impair study participation or cooperation
- •13. Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C
- •virus (HCV) infection
研究者
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