通用名称

paclitaxel

儿科标签批准日期

2019/12/6 0:00:00

特定指示/秒

Recurrent or refractory pediatric solid tumors

标签更改摘要

- Safety and effectiveness in pediatric patients have not been established. - Pharmacokinetics, safety, and antitumor activity were assessed in an open-label, dose escalation, dose expansion study in 96 pediatric patients aged 1.4 to < 17 years with recurrent or refractory pediatric solid tumors. - The maximum tolerated dose (MTD) normalized for body surface area (BSA) was lower in pediatric patients compared to adults. - No new safety signals were observed in pediatric patients across these studies. - Paclitaxel protein-bound exposures normalized by dose were higher in 96 pediatric patients aged 1.4 to < 17 years as compared to those in adults.

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

1 YEARS - 24 YEARS 2 YEARS - 17 YEARS

学习类型

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

研究设计

Multicenter,Open-Label,Dose Finding,Phase 2 Multicenter,Open-Label,Dose Ranging,Dose Finding,Phase 1

登记的患者

42 64

患者分析

42 64

中心的数量

20 20

国家数量

7 7

西班牙裔拉美裔/拉丁裔总计

7 10

非西班牙裔/非拉丁裔总人数

27 38

总数#种族不明

8 16

亚裔学生总数

N/A N/A

黑人总数

1 N/A

白人总数

34 50

夏威夷或太平洋岛民总数

N/A N/A

美洲印第安人/阿拉斯加本地人总数

N/A N/A

其他种族总计

0 3

未知种族总数

7 11

国家

United States,Canada,France,Italy,Spain,Switzerland,United Kingdom United States,Canada,France,Italy,Spain,Switzerland,United Kingdom