Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT02232620
Status:
TERMINATED
Last Update Posted:
2023-11-14
First Post:
2014-09-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of BBI503 in Adult Patients With Advanced Gastrointestinal Stromal Tumors
Sponsor:
Sumitomo Pharma America, Inc.
Organization:
Study Overview
Official Title:
A Phase II Clinical Study of BBI503 in Adult Patients With Advanced Gastrointestinal Stromal Tumors
Status:
TERMINATED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low feasibility
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 gastrointestinal stromal tumor 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 due to disease progression, adverse events, or another discontinuation criterion.
Safety, tolerability and efficacy of BBI503 will be assessed for the duration of study treatment.
Safety, tolerability and efficacy 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?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: