Phase I Study To Determine The Maximally Tolerated Dose Of Oral, Daily CP-868,596 And CP-868,596 Plus AG-013736 When Given In Combination With Docetaxel Administered Every 3 Weeks To Patients With Advanced Solid Tumors
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
- First-cycle Dose Limiting Toxicities
研究概览
简要总结
A5301005 is a phase 1 study in patients with solid tumors which is testing the safety and tolerability of adding targeted agents to a standard chemotherapy. CP-868,596 is a platelet-derived growth factor receptor inhibitor (PDGFR) and AG-13736 is a vascular endothelial growth factor receptor inhibitor (VEGFR). This study will test the use of docetaxel (the standard chemotherapy) with either CP-868,596 or the combination of CP-868,596 and AG-13736.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be ≥18 years old and with histologically or cytologically confirmed advanced solid tumors refractory/resistant to currently available therapies or for which there is no standard therapy.
- •Patients with primary brain tumors are not eligible.
- •Have at least one site of measurable disease.
排除标准
- •Received chemotherapy (including targeted agents such as erlotinib), radiotherapy, immunotherapy or any investigational therapy within 3 weeks of study entry (within 6 weeks for previous treatments with nitrosoureas or mitomycin C).
- •Received tamoxifen within 4 weeks prior to study entry.
研究组 & 干预措施
Cohort 1
60 mg BID/ 75 mg/m2
干预措施: CP-868,596 (Drug)
Cohort 1
60 mg BID/ 75 mg/m2
干预措施: Docetaxel (Drug)
Cohort 2
100 mg BID/75 mg/m2
干预措施: CP-868,596 (Drug)
Cohort 2
100 mg BID/75 mg/m2
干预措施: Docetaxel (Drug)
Cohort 3
100 mg BID/100 mg/m2
干预措施: CP-868,596 (Drug)
Cohort 3
100 mg BID/100 mg/m2
干预措施: Docetaxel (Drug)
Cohort 4b
CP-868,596 + AG-013736 + TXT 75
干预措施: CP-868,596 (Drug)
Cohort 4b
CP-868,596 + AG-013736 + TXT 75
干预措施: AG-013736 (Drug)
Cohort 4b
CP-868,596 + AG-013736 + TXT 75
干预措施: Docetaxel (Drug)
结局指标
主要结局
First-cycle Dose Limiting Toxicities
时间窗: 2.5 years
次要结局
- Determine the safety and tolerability of the combination of daily CP-868,596 and docetaxel on an every 3-week schedule(2.5 years)
- Determine the safety and tolerability of the combination of daily CP-868,596 plus daily AG-013736 plus docetaxel on an every 3-week schedule(2.5 years)
- To evaluate the pharmacokinetics (PK) of CP-868,596 and docetaxel when given in combination(2.5 years)
- To evaluate the pharmacokinetics (PK) of CP-868,596, AG-013736 and docetaxel when given in combination(2.5 years)
- Conduct biomarker investigations on plasma/serum samples to explore critical events in pharmacodynamic response to CP-868,596 (eg, VEGF, phospho-SHP, etc.)(2.5 years)
- To explore the relationship between polymorphisms in genes involved in the metabolism and transport of CP-868,596 and pharmacokinetic/pharmacodynamic parameters(2.5 years)
- To explore the effects of CP-868,596 on tumor blood flow and permeability via DCE-MRI(2.5 years)
- To assess any preliminary clinical evidence of anti-tumor activity using RECIST(2.5 years)