NCT00528619已完成1 期
Phase I Study Of SU011248 In Combination With Pemetrexed, Pemetrexed/Cisplatin And Pemetrexed/Carboplatin In Patients With Advanced Solid Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- To determine maximally tolerated dose of SU011248 (dosed continuously or on a 2/1 Schedule) when given in combination with pemetrexed, pemetrexed and cisplatin or pemetrexed and carboplatin.
研究概览
简要总结
This study will assess the maximum tolerated dose, overall safety and antitumor activity of SU011248 in combination with pemetrexed, pemetrexed and cisplatin or pemetrexed and carboplatin in patients with advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Patients with a diagnosis of a solid cancer which is not responsive to standard therapy or for which no standard therapy exists.
- •Patient has a good performance status (ECOG 0 or 1).
排除标准
- •Prior treatment with either pemetrexed or SU
- •Coughing up blood within 4 weeks before starting study treatment (small amounts okay).
- •Hypertension that cannot be controlled by medications.
研究组 & 干预措施
A
Experimental
干预措施: Sunitinib, Pemetrexed, Cisplatin, Carboplatin (Drug)
结局指标
主要结局
To determine maximally tolerated dose of SU011248 (dosed continuously or on a 2/1 Schedule) when given in combination with pemetrexed, pemetrexed and cisplatin or pemetrexed and carboplatin.
时间窗: From screening until at least 28 days beyond discontinuation of study treatment
次要结局
- To evaluate the plasma pharmacokinetics of SU011248 and its metabolite, SU012662 in addition to pemetrexed, SU011248 and pemetrexed/cisplatin, and SU011248 and pemetrexed/carboplatin when these drugs are co-administered.(From screening until disease progression or discontinuation of the study)
- To preliminarily assess the antitumor activity of SU011248 in addition to pemetrexed, SU011248 and pemetrexed/cisplatin, and SU011248 and pemetrexed/carboplatin in patients with non-small cell lung cancer or advanced unresectable mesothelioma.(From screening until disease progression or discontinuation of the study)
研究者
研究点 (1)
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