Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04773782
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-06-15
First Post:
2021-02-09
Brief Title:
A Study of Avapritinib in Pediatric Patients With Solid Tumors Dependent on KIT or PDGFRA Signaling
Sponsor:
Blueprint Medicines Corporation
Organization:
Blueprint Medicines Corporation
Study Overview
Official Title:
A Phase 12 Single-arm Study to Evaluate the Safety Pharmacokinetics and Antitumor Activity of Avapritinib in Pediatric Patients With Solid Tumors Dependent on KIT or PDGFRA Signaling
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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 12 multicenter open-label trial of avapritinib in participants 2 to 18 years of age with advanced relapsedrefractory RR solid tumors including central nervous system CNS tumors that harbor a PDGFRA andor KIT mutation including non-synonymous point mutations insertions and deletions or amplification or DMG-H3K27a who have no available curative treatment options This is a single-arm trial in which all participants will receive avapritinib The study consists of 2 parts dose confirmation safety and PK Part 1 and initial efficacy safety and PK at the Part 2 recommended dose Part 2
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