Ignite Creation Date:
2024-05-06 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05222165
Status:
WITHDRAWN
Last Update Posted:
2023-02-23
First Post:
2022-01-12
Brief Title:
Study With Infigratinib in Subjects With Advanced Solid and CNS Tumors or Recurrent or Progressive Low-Grade Glioma With Selected FGFR1-3 Alterations
Sponsor:
Helsinn Healthcare SA
Organization:
Helsinn Healthcare SA
Study Overview
Official Title:
A Phase 1b2 Multicenter Open-Label Study of Oral Infigratinib in Pediatric Subjects With Advanced Solid and Central Nervous System CNS Tumors Phase 1b and in Subjects With Recurrent or Progressive Low-Grade Gliomas Harboring Selected FGFR1 FGFR2 or FGFR3 Alterations Phase 2
Status:
WITHDRAWN
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The company decided to interrupt the development of the drug in all oncological indications
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NEWEL
Brief Summary:
The phase 1b study is aimed at determining the pediatric recommended phase 2 dose RP2D of Infigratinib
The phase 2 study will evaluate efficacy and safety of infigratinib
The phase 2 study will evaluate efficacy and safety of infigratinib
Detailed Description:
Phase 1b
Pediatric subjects with advanced solid and CNS tumors or recurrent or progressive Low-Grade Glioma with selected FGFR1-3 alterations will follow a standard dose escalation in 3 dose levels to determine the pediatric recommended Phase 2 dose RP2D and to assess the safety
Dose escalation decisions will be assessed through three dose level cohorts
Phase 2
To evaluate the efficacy and safety in Pediatric and adult subjects with LGG with selected FGFR1-3 alterations including subjects who received infigratinib at the RP2D
Pediatric subjects with advanced solid and CNS tumors or recurrent or progressive Low-Grade Glioma with selected FGFR1-3 alterations will follow a standard dose escalation in 3 dose levels to determine the pediatric recommended Phase 2 dose RP2D and to assess the safety
Dose escalation decisions will be assessed through three dose level cohorts
Phase 2
To evaluate the efficacy and safety in Pediatric and adult subjects with LGG with selected FGFR1-3 alterations including subjects who received infigratinib at the RP2D
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 |
|---|---|---|---|
| 2021-005614-34 | EUDRACT_NUMBER | None | None |