EUCTR2006-002381-18-GB进行中（未招募）1 期
An Open-Label Extension Study to Assess the Safety and Efficacy of Pazopanib in Subjects with Renal Cell Carcinoma previously enrolled on Protocol VEG105192
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
入选标准
- •1. Signed written informed consent.
- •2. Have been enrolled into study VEG105192 and have documented disease progression after being randomized into the placebo arm.
- •3. A woman is eligible to participate in the study if she is of:
- •a.Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), as defined in the protocol).
- •b.Childbearing potential, has a negative serum pregnancy test within 2 weeks of the first dose of pazopanib, and agrees to use adequate contraception. GSK acceptable contraceptive methods are defined in the protocol.
- •4. ECOG PS 0, 1, 2
- •5. Adequate baseline organ function at the baseline visit as defined in the protocol.
- •6. At least 4 weeks must have elapsed since the last surgery and 2 weeks must have elapsed since radiotherapy.
- •7. Complete recovery from prior surgery, and/or reduction of all AEs to Grade 1 from prior systemic therapy or radiotherapy.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years)
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Has received any anti-cancer therapy since discontinuation of VEG105192 study
- •2. Pregnant or lactating female.
- •3. Malabsorption syndrome or disease that significantly affects gastrointestinal function, or major resection of the stomach or small bowel that could affect the absorption of pazopanib.
- •4. Symptomatic central nervous system (CNS) metastasis or leptomeningeal tumors.
- •5. Unable to swallow and retain orally administered medication.
- •6. Active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to beginning study treatment.
- •7. History of human immunodeficiency virus infection.
- •8. Presence of uncontrolled infection.
- •9. Corrected QT interval (QTc) prolongation at baseline defined as QTc interval > 470 msecs.
- •10. History of Class III or IV congestive heart failure according to New York Heart Association (NYHA) classification [See Section 12.3 Appendix 3 for description].
- •11. History of any of the cardiac conditions lsited in the protocol within the past 6 months.
- •12. History of cerebrovascular accident or pulmonary embolus within the past 6 months.
- •13. Poorly controlled hypertension at baseline [as defined in the protocol].
- •14. History of untreated deep venous thrombosis (DVT) within the past 6 months.
- •15. Presence of any non-healing wound, fracture, or ulcer, or presence of symptomatic peripheral vascular disease.
- •16. Evidence of bleeding diathesis or coagulopathy.
- •17. Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with subject’s safety, obtaining informed consent or compliance to the study.
- •18. Has taken any prohibited medications that are listed in the protocol within 14 days of the first dose of pazopanib.
研究者
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