EUCTR2009-016675-29-GB进行中（未招募）1 期
A Phase II Study Investigating Upfront Pazopanib in Metastatic Clear Cell Renal Cancer [PANTHER] - PANTHER (version 6, 23 March 2012)
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 104
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
- •Histopathologically confirmed clear cell carcinoma with measurable metastases on CT/MRI imaging (by RECIST). Only a component of clear cell is required.
- •No prior systemic treatment or nephrectomy for RCC. Palliative radiotherapy is acceptable to non target lesions.
- •Adequate organ function as defined by the following criteria:
- •i.Total serum bilirubin =1.5 x uln (patients with gilbert’s disease exempt)
- •ii.Serum transaminases (ALT) <3 x uln
- •iii.Calculated creatinine clearance >30ml/min
- •iv.Absolute neutrophil count (ANC) =1000/mm3 without growth factor support
- •v.Platelets = 75,000/mm3
- •Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrolment.
- •Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other study procedures
- •ECOG performance status of 0, 1 or 2.
- •18 years or above (no upper age limit)
- •Male or female
- •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
- •Congestive heart failure (class III or IV NYHA), myocardial infarction or coronary artery bypass graft/ stenting or stroke in the previous six months, ongoing severe or unstable arrhythmia requiring medication.
- •Previous treatment for renal cancer
- •Pregnancy or breastfeeding. Female patients must be surgically sterile, be postmenopausal, or must agree to use adequate contraception during the period of therapy.
- •Male patients must be surgically sterile or agree to use adequate contraception during the period of therapy.
- •Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would in the judgement of the investigator, impart excess risk associated with study participation or study drug administration, or which, in the judgement of the investigator, would make the patient inappropriate for entry into this study
- •Prolonged QT interval >480msecs
- •Ongoing major gastrointestinal disease including ulcerative colitis, bleeding peptic ulcer disease or inflammatory bowel disease.
- •Bleeding diathesis
- •Current uncontrolled hypertension
- •Another malignancy requiring treatment within the last 5 years. Local prostate cancer not requiring hormone therapy or an asymptomatic raised PSA is acceptable.
研究者
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