Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2026-01-06 @ 8:33 PM
Study NCT ID:
NCT02431260
Status:
TERMINATED
Last Update Posted:
2019-06-14
First Post:
2015-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Open-Label, Dose-Escalation Study of INCB054329 in Patients With Advanced Malignancies
Sponsor:
Incyte Corporation
Organization:
Study Overview
Official Title:
A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB054329 in Subjects With Advanced Malignancies
Status:
TERMINATED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
As of 31 JAN 2018, the study was terminated by the sponsor due to PK variability.
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT03896815
Has Expanded Access, NCT# Status:
NO_LONGER_AVAILABLE
Acronym:
None
Brief Summary:
This was a study of INCB054329 given to patients with advanced malignancies that were conducted in three treatment groups. Each treatment group had a dose escalation (Part 1) and a dose expansion (Part 3), two of the treatment groups also had an intra-patient dose titration (Part 2).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: