Ignite Creation Date:
2024-05-06 @ 9:48 AM
Last Modification Date:
2024-10-26 @ 12:19 PM
Study NCT ID:
NCT03070990
Status:
COMPLETED
Last Update Posted:
2020-03-04
First Post:
2017-03-01
Brief Title:
A Study of Enfortumab Vedotin in Japanese Subjects With Locally Advanced or Metastatic Urothelial Carcinoma
Sponsor:
Astellas Pharma Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
An Open-label Randomized Phase 1 Safety and Pharmacokinetic Study of Enfortumab Vedotin ASG-22CE in Japanese Patients With Locally Advanced or Metastatic Urothelial Carcinoma
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to assess the safety tolerability and pharmacokinetics of enfortumab vedotin ASG-22CE when administered intravenously to Japanese subjects with locally advanced or metastatic urothelial carcinoma This study will also assess the immunogenicity as defined by the incidence of anti-drug antibody ADA and anti-tumor activity of enfortumab vedotin ASG-22CE when administered intravenously to Japanese subjects with locally advanced or metastatic urothelial carcinoma
Detailed Description:
All subjects will receive a single 30 minute intravenous IV infusion of enfortumab vedotin ASG-22CE once weekly for 3 weeks of every 4 weeks ie on Days 1 8 and 15 A cycle is 28 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None