Ignite Creation Date:
2024-05-06 @ 2:08 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04224272
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-06
First Post:
2020-01-07
Brief Title:
A Study of ZW25 Zanidatamab With Palbociclib Plus Fulvestrant in Patients With HER2HR Advanced Breast Cancer
Sponsor:
Jazz Pharmaceuticals
Organization:
Jazz Pharmaceuticals
Study Overview
Official Title:
Phase 2a Study of ZW25 in Combination With Palbociclib Plus Fulvestrant
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT04578444
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
None
Brief Summary:
This is a multicenter Phase 2a open-label 2-part study to investigate the safety tolerability and anti-tumor activity of ZW25 zanidatamab in combination with palbociclib plus fulvestrant Eligible patients include those with locally advanced unresectable andor metastatic human epidermal growth factor receptor 2 HER2-positive hormone receptor HR-positive breast cancer
Detailed Description:
Part 1 of the study will first evaluate the safety and tolerability of ZW25 in combination with palbociclib plus fulvestrant and will confirm the recommended doses RDs of ZW25 and palbociclib in this combination Part 2 of the study will evaluate the anti-tumor activity of the combination of ZW25 with palbociclib plus fulvestrant at the RD level in patients with HER2-positive HR-positive advanced breast cancer
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-002956-18 | EUDRACT_NUMBER | None | None |