通用名称

sunitinib malate

儿科标签批准日期

2019/5/7 0:00:00

特定指示/秒

Refractory solid tumors

标签更改摘要

- Safety and effectiveness in pediatric patients have not been established. - Safety and pharmacokinetics were assessed in an open-label study in pediatric patients 2 years to <17 years of age (n=29) with refractory solid tumors. In addition, efficacy, safety and pharmacokinetics was assessed in another open-label study in pediatric patients 2 years to <17 years (n=27) with high-grade glioma or ependymoma. - The maximum tolerated dose normalized for body surface area was lower in pediatric patients compared to adults. - Sunitinib was poorly tolerated in pediatric patients. - The effect on open tibial growth plates in pediatric patients who received Sutent has not been adequately studied. - Information on adverse reactions and clinical trials.

治疗类别

N/A

立法类型

BPCA Only

产品说明书链接

书号

2.0 1.0

研究年龄

18 MONTHS - 22 YEARS 3 YEARS - 21 YEARS

学习类型

Efficacy,Safety,Pharmacokinetic,Pharmacodynamic,Tolerability Efficacy,Safety,Pharmacokinetic,Pharmacodynamic,Tolerability

研究设计

Open-Label,Phase 2 Open-Label,Phase 1,Dose Escalation,Sequential Cohort

登记的患者

30 35

患者分析

29 35

中心的数量

23 21

国家数量

3 1

西班牙裔拉美裔/拉丁裔总计

N/A N/A

非西班牙裔/非拉丁裔总人数

N/A N/A

总数#种族不明

0 3

亚裔学生总数

0 3

黑人总数

3 7

白人总数

24 20

夏威夷或太平洋岛民总数

0 0

美洲印第安人/阿拉斯加本地人总数

0 0

其他种族总计

2 2

未知种族总数

N/A N/A

国家

N/A N/A