Ignite Creation Date:
2024-05-06 @ 2:02 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04197986
Status:
TERMINATED
Last Update Posted:
2024-03-13
First Post:
2019-12-02
Brief Title:
Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations
Sponsor:
QED Therapeutics Inc
Organization:
QED Therapeutics Inc
Study Overview
Official Title:
Phase 3 Multicenter Double-Blind Randomized Placebo-Controlled Trial of Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations PROOF 302
Status:
TERMINATED
Status Verified Date:
2024-02
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 The discontinuation of the study was not due to safety reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROOF302
Brief Summary:
This is a Phase 3 multicenter double-blind randomized placebo-controlled study to evaluate the efficacy of infigratinib an oral targeted FGFR1-3 inhibitor versus placebo as adjuvant treatment following surgery in adult subjects with invasive urothelial carcinoma and susceptible FGFR3 genetic alterations mutations and gene fusions or rearrangements who have disease that is considered at high risk for recurrence with surgery alone The study enrolls subjects with either bladder cancer post radical cystectomy or upper tract urothelial cancer post distal ureterectomy andor nephrectomy Study treatment is randomized 11 between infigratinib or placebo with treatment up to 1 year or until invasive local distal or metastatic disease recurrence confirmed by independent imaging reviewer
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 |
|---|---|---|---|
| 2019-003248-63 | EUDRACT_NUMBER | None | None |