Phase I Chinese PK
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赞助商
Genzyme, a Sanofi Company
临床试验: NCT00503711
BioSeek: nct00503711
关键词
抽象
An open, phase 1 to assess the PK of rising doses of ZD6474 when administered daily in Chinese patients with advanced solid malignant tumors.
日期
| 最后验证: | 07/31/2016 |
| 首次提交: | 07/17/2007 |
| 提交的预估入学人数: | 07/17/2007 |
| 首次发布: | 07/18/2007 |
| 上次提交的更新: | 08/28/2016 |
| 最近更新发布: | 08/30/2016 |
| 实际学习开始日期: | 08/31/2006 |
| 预计主要完成日期: | 10/31/2007 |
| 预计完成日期: | 10/31/2007 |
状况或疾病
Advanced Solid, Malignant Tumors
干预/治疗
Drug: Vandetanib
Drug: 300 mg Vandetanib od
相
相 1
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: 100 mg Vandetanib eod 100 mg Vandetanib every other day dosing | |
| Experimental: 100 mg Vandetanib od 100 mg Vandetanib once daily dosing | |
| Experimental: 300 mg Vandetanib od 300 mg Vandetanib once daily dosing | Drug: 300 mg Vandetanib od 300mg once daily |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - histological and/or cytological confirmation of a malignant solid tumor - refractory to standard therapies or for which no appropriate therapies exist - WHO performance status 0-2 Exclusion Criteria: - patients with brain tumors or symptomatic cerebral metastases - systemic anticancer therapy within the last 4 weeks |
结果
主要结果指标
1. Area under the curve (AUC) (0-24) (ng.h/mL) after single dose [Blood sample is collected at 1, 2, 4, 6, 8, 10 & 24 hour after first single dose on day 1]
