Ignite Creation Date:
2024-05-06 @ 1:12 AM
Last Modification Date:
2024-10-26 @ 11:00 AM
Study NCT ID:
NCT01752920
Status:
COMPLETED
Last Update Posted:
2023-06-05
First Post:
2012-12-14
Brief Title:
Phase 12 Study of Derazantinib ARQ 087 in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations
Sponsor:
Basilea Pharmaceutica
Organization:
Basilea Pharmaceutica
Study Overview
Official Title:
A Phase 12 Study of ARQ 087 in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations Including Intrahepatic Cholangiocarcinoma With FGFR2 Gene Fusion
Status:
COMPLETED
Status Verified Date:
2023-05
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 was an open-label Phase 12 dose escalation and signal finding study of derazantinib administered to patients with advanced solid tumors Part 1 Dose EscalationFood-effect Cohorts or with advanced solid tumors with FGFR genetic aberrations including iCCA with FGFR2 gene fusion Part 2 Expanded Cohort signal finding
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?:
None