Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-01-26 @ 2:52 AM
Study NCT ID:
NCT02793466
Status:
COMPLETED
Last Update Posted:
2023-09-22
First Post:
2016-04-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Durvalumab in Pediatric and Adolescent Patients
Sponsor:
Leo Mascarenhas
Organization:
Study Overview
Official Title:
A Phase I, Open-Label, Single Institution Study to Assess the Safety, Tolerability, and Pharmacokinetics of Durvalumab in Pediatric Patients With Relapsed or Refractory Solid Tumors, Lymphoma, and Central Nervous System Tumors
Status:
COMPLETED
Status Verified Date:
2023-09
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 clinical trial is the first clinical trial to study Durvalumab, a checkpoint inhibitor which stimulates the patient's own immune system to act against cancer cells in children and adolescents. This trial will assess the safety and tolerability of Durvalumab in children and adolescents and also study how Durvalumab is processed in their bodies.
Detailed Description:
This trial will assess the safety and tolerability of Durvalumab in children and adolescents and also study how Durvalumab is processed in their bodies.
Study Oversight
Has Oversight DMC:
True
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?: