Ignite Creation Date:
2024-05-06 @ 12:30 PM
Last Modification Date:
2024-10-26 @ 12:59 PM
Study NCT ID:
NCT03773302
Status:
TERMINATED
Last Update Posted:
2024-05-08
First Post:
2018-12-10
Brief Title:
Phase 3 Study of BGJ398 Oral Infigratinib in First Line Cholangiocarcinoma With FGFR2 Gene FusionsTranslocations
Sponsor:
QED Therapeutics Inc
Organization:
QED Therapeutics Inc
Study Overview
Official Title:
A Phase 3 Multicenter Open-Label Randomized Controlled Study of Oral Infigratinib Versus Gemcitabine With Cisplatin in Subjects With AdvancedMetastatic or Inoperable Cholangiocarcinoma With FGFR2 Gene FusionsTranslocations The PROOF Trial
Status:
TERMINATED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The sponsor has decided to close the study due to the discontinuation of infigratinib development in oncology within the sponsors territory The discontinuation of the study was not due to safety issues
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Infigratinib is an oral drug which selectively binds to fibroblast growth factor receptor FGFR 2 and is being developed to treat participants with FGFR2 mutated cholangiocarcinoma The purpose of the study is to evaluate the efficacy and safety of the investigational agent oral infigratinib vs standard of care chemotherapy gemcitabine plus cisplatin in first-line treatment of participants with unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusionrearrangement Subjects will be randomized 21 to receive infigratinib or gemcitabine plus cisplatin
Detailed Description:
None
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 |
|---|---|---|---|
| 2018-004004-19 | EUDRACT_NUMBER | None | None |