EUCTR2006-000143-26-IT进行中（未招募）不适用
A Phase II, Non-randomized, Multicenter Study to Evaluate the Safety and Efficacy of Pazopanib GW786034 as Pre-Surgical Therapy in Treatment-Na ve Subjects with Stage IA or IB, Resectable Non Small Cell Lung Cancer NSCLC - Pazopanib as pre-surgical therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 33
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. Signed, written informed consent prior to performing any study-related procedures, including the collection of a fresh tumor biopsy sample. 2. Subjects 21 years of age with a life expectancy of 12 weeks. 3. The time between initial diagnosis and the scheduled surgery date allow for the subject to receive a minimum of 2 weeks or a maximum of 6 weeks treatment with pazopanib. Note At least 4 weeks between initial biopsy and surgery must be planned to allow for the one week wait following the final biopsy and the 1 week washout period. 4. Eastern Cooperative Oncology Group ECOG performance status PS 0 or 1. 5. Histologically or cytologically confirmed stage IA and IB NSCLC according to the International Staging System Mountain, 1997 and must be candidates for surgical resection. 6. Disease must be measurable according high-resolution CT scan-assisted volumetric measurement, as specified in Section 14.5, Appendix 5 . 7. No prior chemotherapy, radiation therapy, immunotherapy, biologic therapy or anti-angiogenic therapy. 8. Fresh tumor biopsy must be provided by all subjects before and after treatment with pazopanib for apoptosis and relevant biomarker analysis. 9. Adeguate Organ System function- as defined in the protocol 10. Ability to swallow or retain oral medication
- •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
- •1. History of other malignancy. Subjects who have been disease-free for 5 years, or subjects with a history of completely resected, non-melanoma skin cancer or successfully treated in situ carcinoma are eligible. 2. Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks prior to beginning therapy, or anticipation of the need for a major surgical procedure during the course of the study; minor surgical procedures such as fine needle aspiration or core biopsy within 1 week prior to beginning therapy are also excluded. 3. History or clinical evidence of central nervous system CNS metastases or leptomeningeal carcinomatosis. Routine screening with CNS imaging studies computed tomography CT or magnetic resonance imaging MRI is required only if clinically indicated. 4. History of hemoptysis. 5. Malabsorption Syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded. 6. Active or uncontrolled infection 7. Concurrent treatment with an investigational agent or participation in another clinical trial or the use of an investigational anti-cancer drug within 30 days of 5 half-lives, whichever is longer, preceding the first dose of pazopanib 8.Prior use of an investigational or licensed drug that targets either VEGF or VEGF receptors. 9. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib.10.Corrected QT interval QTc prolongation defined as QTc interval 470 msecs 11.History of any one of the following cardiac conditions within the past 6 months Cardiac angioplasty or stenting,Myocardial infarction,Unstable angina 12.Has Class II, III or IV heart failure as defined by the New York Heart Association NYHA functional classification system.13.Poorly controlled hypertension systolic blood pressure SBP of 140mmHg, or diastolic blood pressure DBP of 90mmHg Note Initiation or adjustment of antihypertensive medication s is permitted prior to study entry. The blood pressure BP must be re-assessed on two occasions that are separated by a minimum of 5 minutes. The mean SBP/DBP values from both BP assessments must be 140/90mmHg in order for a subject to be eligible for the study.14. Presence of any non-healing wound, fracture, or ulcer, or the presence of symptomatic peripheral vascular disease. 15.Receiving therapeutic warfarin or heparin as a concurrent medication. Note Prophylactic low-dose warfarin is permitted. 16.Evidence of bleeding diathesis or coagulopathy
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