Ignite Creation Date:
2024-05-06 @ 7:17 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02508467
Status:
COMPLETED
Last Update Posted:
2024-04-12
First Post:
2015-07-09
Brief Title:
A Phase 1 Study of Fisogatinib BLU-554 in Patients With Hepatocellular Carcinoma
Sponsor:
Blueprint Medicines Corporation
Organization:
Blueprint Medicines Corporation
Study Overview
Official Title:
A Phase 1 Study to Assess the Safety Tolerability Pharmacokinetics Pharmacodynamics and Preliminary Efficacy of BLU-554 in Patients With Hepatocellular Carcinoma
Status:
COMPLETED
Status Verified Date:
2024-03
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 a Phase 1 open-label first-in-human FIH study designed to evaluate the safety tolerability pharmacokinetics PK pharmacodynamics PD and preliminary antineoplastic activity of fisogatinib formerly known as BLU- 554 administered orally in patients with FGF19 IHC hepatocellular carcinoma HCC The study consists of 3 parts a dose-escalation part Part 1 an expansion part Part 2 exploring a once daily qd dosing schedule at the recommended Phase 2 dose RP2D and a Part 3 expansion of the qd dosing schedule at the RP2D in TKI naive patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015-001662-26 | EUDRACT_NUMBER | None | None |