Ignite Creation Date:
2024-05-06 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05266105
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-06
First Post:
2022-02-11
Brief Title:
A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HRHER2- Breast Cancer Patients
Sponsor:
Olema Pharmaceuticals Inc
Organization:
Olema Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 1 Dose Escalation and Expansion Open-label Multicenter Study of OP-1250 in Combination With the CDK46 Inhibitor Palbociclib in Adult Subjects With Advanced or Metastatic HR-positive HER2-negative Breast Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
Recruiting
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 an open-label Phase 1b dose escalation and expansion study to determine the maximum tolerated dose MTD of OP-1250 in combination with palbociclib Ibrance Pfizer Inc Purpose of study is to evaluate the safety and pharmacokinetic PK profile and estimate the preliminary anti-tumor activity of the combination in adult subjects with hormone receptor-positive ER HER2- advanced or metastatic breast cancer MBC
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?:
True
Is an FDA AA801 Violation?:
None