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
- 50
- 试验地点
- 1
- 主要终点
- Plasma AUC(0-24) of pazopanib on Day 1, 14 and 21 Plasma AUC(0-46) of 5-FU and AUC(0-8) of platinum on Day 1 Plasma AUC(0-24) of capecitabine, 5-FU, and platinum on Day 1
研究概览
简要总结
This study will test the safety of treating colorectal cancer with a combination of drugs. The current standard treatments of FOLFOX6 or CapeOx will be give in combination with the GSK investigational drug pazopanib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
- •Adequate bone marrow, hepatic, renal function, Urine Creatinine Ratio (UPC) of <
- •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.
研究组 & 干预措施
FOLFOX 6 + Pazopanib
Subjects will receive escalating doses of Pazopanib in combination with FOLFOX 6.
干预措施: Pazopanib (Drug)
FOLFOX 6 + Pazopanib
Subjects will receive escalating doses of Pazopanib in combination with FOLFOX 6.
干预措施: FOLFOX 6 (Drug)
CapeOx + Pazopanib
Subjects will receive escalating doses of Pazopanib in combination with CapeOx. CapeOx treatment consisted of IV oxaliplatin (130 mg/m^2) on Day 1 plus oral capecitabine (1000 mg/m^2) twice daily on Days 2 through 14 of every 21-day cycle. Reduced CapeOx treatment was administered according to the same schedule as the CapeOx treatment, but the dose of capecitabine was reduced to 850 mg/m^2 twice daily.
干预措施: Pazopanib (Drug)
CapeOx + Pazopanib
Subjects will receive escalating doses of Pazopanib in combination with CapeOx. CapeOx treatment consisted of IV oxaliplatin (130 mg/m^2) on Day 1 plus oral capecitabine (1000 mg/m^2) twice daily on Days 2 through 14 of every 21-day cycle. Reduced CapeOx treatment was administered according to the same schedule as the CapeOx treatment, but the dose of capecitabine was reduced to 850 mg/m^2 twice daily.
干预措施: CapeOx (Drug)
结局指标
主要结局
Plasma AUC(0-24) of pazopanib on Day 1, 14 and 21 Plasma AUC(0-46) of 5-FU and AUC(0-8) of platinum on Day 1 Plasma AUC(0-24) of capecitabine, 5-FU, and platinum on Day 1
时间窗: on Day 1, 14 and 21
次要结局
- Pharmacokinetic endpoints (AUC, C24, Cmax, tmax, and half-life)collected predose and 1, 2, 3, 4, 5, 6, 8, and 24 hours on Day 1. Assessment of disease by imaging(collected predose and 1, 2, 3, 4, 5, 6, 8, and 24 hours on Day 1.)