通用名称

ramucirumab

儿科标签批准日期

2021/6/15 0:00:00

特定指示/秒

Relapsed or refractory solid tumors

标签更改摘要

- Safety and effectiveness in pediatric patients have not been established. - Safety and effectiveness as a single agent were assessed but not established in a single-arm, multicenter, open-label study that included 23 pediatric patients aged 1 year to 16 years with relapsed or refractory solid tumors. - The effect on open tibial growth plates in pediatric patients who received Cyramza has not been adequately studied; however, one patient in this study had progressive widening of distal femoral growth plate. - No other new safety signals were observed in pediatric patients. The pharmacokinetics (PK) for these pediatric patients was within the range of the values previously observed in adults given the same dose per body weight. - Postmarketing study.

治疗类别

Solid Tumor

立法类型

BPCA Only

产品说明书链接

书号

1.0

研究年龄

1 YEARS - 21 YEARS

学习类型

Efficacy,Safety,Pharmacokinetic,Tolerability

研究设计

Multicenter,Open-Label,Dose Finding,Phase 1,Single-arm

登记的患者

29

患者分析

29

中心的数量

20

国家数量

1

西班牙裔拉美裔/拉丁裔总计

6

非西班牙裔/非拉丁裔总人数

22

总数#种族不明

1

亚裔学生总数

0

黑人总数

3

白人总数

23

夏威夷或太平洋岛民总数

0

美洲印第安人/阿拉斯加本地人总数

0

其他种族总计

0

未知种族总数

3

国家

United States