Ignite Creation Date:
2024-05-06 @ 9:17 AM
Last Modification Date:
2024-10-26 @ 12:12 PM
Study NCT ID:
NCT02942290
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2016-10-18
Brief Title:
A Study Evaluating Venetoclax in Combination With Azacitidine in Participants With Treatment-Naïve Higher-Risk Myelodysplastic Syndromes MDS
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
A Phase 1b Dose Escalation Study Evaluating the Safety and Pharmacokinetics of Venetoclax in Combination With Azacitidine in Subjects With Treatment-Naïve Higher-Risk Myelodysplastic Syndromes MDS
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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 1b open-label non-randomized multicenter dose-finding study evaluating venetoclax in combination with azacitidine in participants with treatment-naïve higher-risk MDS comprising a dose-escalation portion and a safety expansion portion
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-001657-41 | EUDRACT_NUMBER | None | None |
| 2023-507154-32-00 | OTHER | None | None |