Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2026-03-08 @ 3:30 AM
Study NCT ID:
NCT02141659
Status:
COMPLETED
Last Update Posted:
2018-11-19
First Post:
2014-05-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of TAK-385 in Hormone Treatment-naïve Participants With Prostate Cancer
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
A Phase 1, Open-label, Multicenter Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of TAK-385 Alone in Hormone Treatment- naïve Japanese Patients With Non-metastatic Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2018-04
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 study is to evaluate the tolerability and safety of TAK-385 in hormone treatment-naïve participants with non-metastatic prostate cancer.
Detailed Description:
The objective of this study is to evaluate the tolerability and safety of TAK-385 in hormone treatment-naive participants with non-metastatic prostate cancer. This study consists of two parts: Part A, multiple dose-rising (MRD) phase and Part B, an expansion phase.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1156-6034 | REGISTRY | WHO | View |