Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2026-01-11 @ 9:04 AM
Study NCT ID:
NCT04514159
Status:
COMPLETED
Last Update Posted:
2023-02-01
First Post:
2020-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of ZN-c5 and Abemaciclib in Participants With Breast Cancer
Sponsor:
Zeno Alpha Inc.
Organization:
Study Overview
Official Title:
A Phase 1b Study of ZN-c5 in Combination With Abemaciclib in Patients With Estrogen-Receptor Positive, Human Epidermal Growth Factor Receptor-2 Negative Advanced Breast Cancer
Status:
COMPLETED
Status Verified Date:
2023-01
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, multicenter, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of ZN-c5 administered orally in combination with abemaciclib (VERZENIO®) in participants with advanced estrogen-receptor positive, human epidermal growth factor receptor-2 negative (ER+/HER2-) breast cancer.
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?: