Ignite Creation Date:
2024-05-06 @ 10:21 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03230318
Status:
COMPLETED
Last Update Posted:
2023-12-19
First Post:
2017-07-24
Brief Title:
Derazantinib in Subjects With FGFR2 Gene Fusion- Mutation- or Amplification- Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma
Sponsor:
Basilea Pharmaceutica
Organization:
Basilea Pharmaceutica
Study Overview
Official Title:
A Pivotal Study of Derazantinib in Patients With Inoperable or Advanced Intrahepatic Cholangiocarcinoma and FGFR2 Gene Fusions or FGFR2 Gene Mutations or Amplifications
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT04087876
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
FIDES-01
Brief Summary:
This Phase II open-label single-arm study evaluated the anti-cancer activity of derazantinib in subjects with inoperable or advanced intrahepatic cholangiocarcinoma iCCA who received at least one prior regimen of systemic therapy Patients received an oral once-daily total dose of 300 mg derazantinib capsules
Detailed Description:
This was a multi-center open-label single arm study which evaluated the anti-cancer activity of derazantinib in adult patients with inoperable or advanced iCCA in the following study population
Patients with inoperable or advanced iCCA and with fibroblast growth factor receptor 2 FGFR2 fusions Substudy 1 or FGFR2 mutationsamplifications Substudy 2 treated with at least one prior regimen of systemic therapy
Derazantinib was supplied as 100 mg capsules A dose of 300 mg once-daily three capsules of 100 mg each of derazantinib was administered orally to patients 1 hour before or 2 hours after a meal
Patients with inoperable or advanced iCCA and with fibroblast growth factor receptor 2 FGFR2 fusions Substudy 1 or FGFR2 mutationsamplifications Substudy 2 treated with at least one prior regimen of systemic therapy
Derazantinib was supplied as 100 mg capsules A dose of 300 mg once-daily three capsules of 100 mg each of derazantinib was administered orally to patients 1 hour before or 2 hours after a meal
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ARQ 087-301 | OTHER | ArQule Inc | None |