Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2026-02-24 @ 3:14 PM
Study NCT ID:
NCT03236857
Status:
COMPLETED
Last Update Posted:
2023-05-22
First Post:
2017-07-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies
Sponsor:
AbbVie
Organization:
Study Overview
Official Title:
A Phase 1 Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT03123029
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
None
Brief Summary:
An open-label, global, multi-center study to evaluate the safety and pharmacokinetics of venetoclax monotherapy, to determine the dose limiting toxicity (DLT) and the recommended Phase 2 dose (RPTD), and to assess the preliminary efficacy of venetoclax in pediatric and young adult participants with relapsed or refractory malignancies.
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2017-000439-14 | EUDRACT_NUMBER | None | View |