EUCTR2006-000143-26-ES进行中（未招募）1 期
A Phase II, Non-randomized, Multicenter Study to Evaluate the Safety and Efficacy of Pazopanib (GW786034) as Pre-Surgical Therapy in Treatment-Naïve Subjects with Stage IA or IB, Resectable Non Small Cell Lung Cancer (NSCLC)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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 Protocol 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.Adequate 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 3 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 or 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.
- •14.Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib.
- •9.Corrected QT interval (QTc) prolongation defined as QTc interval > 470 msecs.
- •10.History of any one of the following cardiac conditions within the past 6 months: Cardiac angioplasty or stenting, Myocardial infarction, Unstable angina
- •11.Has Class II, III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
- •12.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.
- •13.Presence of any non-healing wound, fracture, or ulcer, or the presence of symptomatic peripheral vascular disease.
- •14.Receiving therapeutic warfarin or heparin as a concurrent medication.
- •Note: Prophylactic low-dose warfarin is permitted.
- •15.Evidence of bleeding diathesis or coagulopathy.
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