Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT01228760
Status:
COMPLETED
Last Update Posted:
2013-06-07
First Post:
2010-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Determine the Maximum Tolerated Dose of ASG-5ME in Subjects With Castration-Resistant Prostate Cancer
Sponsor:
Astellas Pharma Inc
Organization:
Study Overview
Official Title:
A Phase 1, Open-label, Multi-center, Dose Escalation Study of the Safety and Pharmacokinetics of ASG-5ME Monotherapy in Subjects With Castration-Resistant Prostate Cancer (CRPC)
Status:
COMPLETED
Status Verified Date:
2013-06
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 purpose of this dose escalation study is to determine the Maximum Tolerated Dose (MTD) and the recommended Phase 2 dose of ASG-5ME in subjects with castration-resistant prostate cancer (CRPC).
Detailed Description:
The study has two components. The first aims to establish a safe dose of ASG-5ME. Once identified, the safety and preliminary estimate of antitumor activity of ASG-5ME will be tested in additional subjects with castration-resistant prostate cancer (CRPC) who are either chemotherapy naïve or chemotherapy exposed in expanded cohorts.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: