Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-30 @ 3:45 AM
Study NCT ID:
NCT04066335
Status:
UNKNOWN
Last Update Posted:
2019-12-18
First Post:
2019-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Safety of Nanoxel M Inj.
Sponsor:
Samyang Biopharmaceuticals Corporation
Organization:
Study Overview
Official Title:
An Observational Study to Evaluate the Safety of Nanoxel M (Docetaxel-PM) Inj.
Status:
UNKNOWN
Status Verified Date:
2019-08
Last Known Status:
RECRUITING
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:
Study to evaluate the safety of Nanoxel M inj. administration in patients.
Detailed Description:
This is a multi-center, prospective observational study to observe the incidence of adverse events under actual clinical settings to test the safety of Nanoxel-M inj. administration in patients with breast cancer, non-small cell lung cancer, prostate cancer, ovarian cancer, head \& neck cancer, gastric cancer or esophageal cancer.
Study Oversight
Has Oversight DMC:
None
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?: