CTRI/2009/091/000516已完成1 期
VEG105424 : An Open-Label, Pharmacokinetic Study of the Safety and Tolerability of Pazopanib in Combination With FOLFOX 6 or CapeOx in Subjects With Colorectal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Diagnosis of locally advanced or metastatic colorectal cancer.
- •No prior chemotherapy for metastatic disease.
- •Presence of radiologically and/or clinically documented disease.
- •Eastern Cooperative Oncology Group performance status of 0 or 1.
- •Adequate bone marrow, hepatic, renal function, Urine Creatinine Ratio (UPC)
- •A female subject must not be pregnant or breast feeding.
- •Able to swallow and retain oral medications.
排除标准
- •Has had any major surgery, chemotherapy, hormone therapy, investigational agent, or radiotherapy within the last 28 days
- •Prior treatment with pazopanib, or oxaliplatin.
- •Known contraindications to the use of oxaliplatin, capecitabine, 5-fluorouracil, or folinic acid.
- •Participation in any investigational study within 28 days prior to study treatment.
- •Women who are pregnant or lactating.
- •Poorly controlled hypertension.
- •A history of cardiovascular disease, arrhythmias, or significant ECG abnormalities.
- •Any history of stroke.
- •Current use of therapeutic warfarin.
- •Known brain metastases.
- •History of disease significantly affecting gastrointestinal function or major resection of the stomach or small bowel.
- •Active infections or other serious illness.
- •History of allergy to platinum compounds or heparin.
- •Poor venous access.
研究者
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