Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-03-02 @ 3:58 PM
Study NCT ID:
NCT02232633
Status:
COMPLETED
Last Update Posted:
2023-11-14
First Post:
2014-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of BBI503 in Adult Patients With Advanced Hepatobiliary Cancer
Sponsor:
Sumitomo Pharma America, Inc.
Organization:
Study Overview
Official Title:
A Phase II Clinical Study of BBI503 in Adult Patients With Advanced Hepatobiliary Cancer
Status:
COMPLETED
Status Verified Date:
2023-11
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:
This is an open label, multi-center, phase II study of BBI503 administered to adult patients with advanced hepatobiliary cancer who have exhausted all currently approved standard anti-cancer treatment options. BBI503 will be administered orally, daily, in continuous 28-day cycles at a dose of 300 mg once daily. Cycles will be repeated until patients are no longer clinically benefiting from therapy.
Safety, efficacy and tolerability of BBI503 will be assessed for the duration of study treatment.
Safety, efficacy and tolerability of BBI503 will be assessed for the duration of study treatment.
Detailed Description:
None
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| BBI503-205HCC | OTHER | Boston Biomedical, Inc. | View |