EUCTR2011-002347-10-CZ进行中（未招募）不适用
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Oral E7080 in Addition to Best Supportive Care (BSC) versus BSC Alone in Patients with Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Who Have Failed at Least Two Systemic Anticancer Regimens
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Eisai Inc.
- 入组人数
- 135
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
- •1. Age =18 years;
- •2. Patients with histologically or cytologically confirmed non-squamous NSCLC with locally advanced or metastatic disease based on Tumor, Node, Metastasis (TNM) staging according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual, Seventh Edition, who have failed at least 2 lines of systemic anticancer therapy for advanced or metastatic NSCLC (does not include adjuvant chemotherapy); In countries where erlotinib is approved and marketed for the treatment of NSCLC, patients must have received erlotinib (or gefitinib for patients outside of the US) for their NSCLC if they have known EGFR activating mutations. Patients of unknown EGFR status who have not received prior erlotinib (or gefitinib) should be tested for EGFR
- •activating mutations prior to study entry. In countries where crizotinib is approved and marketed, patients must have received
- •crizotinib treatment for NSCLC that is anaplastic lymphoma kinase
- •(ALK)-positive. Patients with ALK-positive NCSLC or patients with KRAS mutations are not required to have prior treatment with erlotinib or gefitinib;
- •3. Patients must have at least 1 site of measurable disease by the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v.1.1);
- •4. ECOG PS of 0 to 2;
- •5. Patients must have adequate renal function as evidenced by serum creatinine =1.5 X upper limit of normal (ULN) or calculated creatinine clearance =30 mL/min per the Cockcroft and Gault formula;
- •6. Blood pressure must be well-controlled (<140/90 mm Hg at Screening) with or without antihypertensive medication. Patients must have no history of hypertensive crisis or hypertensive encephalopathy;
- •7. Patients must have adequate bone marrow function as evidenced by absolute neutrophil count (ANC) =1.5 X 109/L, hemoglobin =9.0 g/dL, and platelet count =100 X 109/L;
- •8. Patients must have adequate liver function as evidenced by bilirubin =1.5 times the ULN, and alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) =3 X ULN (in the case of liver metastases, =5 X ULN). If there are bone metastases, liver-specific alkaline phosphatase may be separated from the total and used to assess liver function instead of total alkaline phosphatase;
- •9. Patients must have adequate coagulation system function as defined by prothrombin time/International normalized ratio (INR) =1.5 X ULN. Patients requiring INR monitoring are excluded. Low molecular weight heparin is allowed;
- •10. 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;
- •11. Females of childbearing potential must have a negative serum pregnancy test;
- •12. Females may not be breastfeeding;
- •13. Ability to understand and willingness to sign a written informed consent.
- •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 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1. Prior therapy with E7080 or other small molecule vascular endothelial growth factor inhibitors;
- •2. Presence of brain metastases, unless the patient has received adequate treatment at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 4 weeks prior to randomization;
- •3. Meningeal carcinomatosis;
- •4. Received chemotherapy, targeted therapy, radiotherapy, surgery, or immunotherapy within the 21 days prior to commencing study treatment or have not recovered from all treatment-related toxicities to Grade =2, except for alopecia;
- •5. Received treatment with another investigational agent within the 30 days prior to commencing study treatment or patients who have not recovered from side effects of an investigational drug to Grade =2, except for alopecia;
- •6. Patients with proteinuria >1+ on urine dipstick testing will undergo 24-hour urine collection for quantitative assessment of proteinuria. Patients with 24-hour urine protein =1 g/24 hours will be ineligible;
- •7. Serious non-healing wound, ulcer, bone fracture, or have undergone a major surgical procedure, open biopsy, or significant traumatic injury within the 28 days prior to commencing study treatment. Minor surgery such as Portacath placement or skin biopsy is permitted if =7 days have passed;
- •8. Major surgery scheduled during the projected course of the study;
- •9. History of bleeding diathesis or coagulopathy;
- •10. Active hemoptysis (defined as bright red blood of a half teaspoon or more) within the 30 days prior to study entry;
- •11. Refractory nausea and vomiting, malabsorption, significant bowel resection, or any other medical condition that would preclude adequate absorption or result in the inability to take oral medication;
- •12. Other malignancy within 3 years of randomization, with the exception of adequately treated carcinoma in situ of the cervix or non-melanoma skin cancer, with no subsequent evidence of recurrence and/or malignancies diagnosed at a stage where definitive therapy results in near certain cures. The Medical Monitor must be consulted in such cases;
- •13. Significant cardiovascular impairment (history of congestive heart failure New York Heart Association [NYHA] Class >II, unstable angina or myocardial infarction within the past 6 months, or serious cardiac arrhythmia);
- •14. Any history of cerebral vascular accident (CVA), transient ischemic attack (TIA), or Grade =2 peripheral vascular disease unless they have had no evidence of active disease for at least 6 months prior to randomization;
- •15. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the 6 months prior to enrollment;
- •16. Patients with organ allografts requiring immunosuppression;
- •17. Known positive human immunodeficiency virus (HIV), known hepatitis B surface antigen, or hepatitis C positive;
- •18. Hypersensitivity to E7080 or any of the excipients;
- •19. Any history of or concomitant medical condition that, in the opinion of the Investigator, would compromise the patient’s ability to safely complete the study.
研究者
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