Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:50 PM
Study NCT ID:
NCT03544567
Status:
COMPLETED
Last Update Posted:
2023-05-19
First Post:
2018-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Oraxol in Subjects With Cutaneous Angiosarcoma
Sponsor:
Athenex, Inc.
Organization:
Study Overview
Official Title:
A Phase 2 Study of Oraxol in Subjects With Cutaneous Angiosarcoma
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a non-blinded, multi-center, open-label, phase 2 study to evaluate the activity, safety, and tolerability of Oraxol in subjects with cutaneous angiosarcoma.
Detailed Description:
Oraxol will be administered once daily for 3 consecutive days every week during the Treatment Period from Weeks 1 through 25.
Subjects who do not have documented disease progression by the end of the Treatment Period will be eligible to receive therapy in the Treatment Extension Period; Oraxol may be administered from Week 26 onwards.
Subjects who do not have documented disease progression by the end of the Treatment Period will be eligible to receive therapy in the Treatment Extension Period; Oraxol may be administered from Week 26 onwards.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: