Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04505826
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-22
First Post:
2020-07-21
Brief Title:
A Dose EscalationExpansion Study of Oral OP-1250 in Subjects With Advanced andor Metastatic HR HER2- Breast Cancer
Sponsor:
Olema Pharmaceuticals Inc
Organization:
Olema Pharmaceuticals Inc
Study Overview
Official Title:
A Phase I Dose Escalation and Dose Expansion and Phase II Monotherapy Open-label First-in-Human Multicenter Study of OP-1250 in Adult Subjects With Advanced andor Metastatic Hormone Receptor HR-Positive HER2-negative Breast Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-08
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 clinical trial is a Phase I dose escalation and dose expansion and Phase II monotherapy open-label first-in-human multicenter study of OP-1250 in adult subjects with advanced andor metastatic hormone receptor HR-positive her2-negative breast cancer
Detailed Description:
This is a Phase I dose escalation and dose expansion and Phase II monotherapy open--label first--in--human study to determine the dose limiting toxicity DLT maximum tolerated dose MTD andor recommended Phase II dose RP2D to characterize the safety and pharmacokinetic PK profile and to estimate the preliminary anti-tumor activity of OP-1250 as a single agent in adult subjects with hormone receptor HR-positivehuman epidermal growth factor receptor 2 HER2-negative metastatic or locally advanced breast cancer This study comprises 2 Phases Phase I Part A Dose Escalation and Part B Dose Expansion and Phase II Additionally all subjects Phase I and Phase II will be eligible to participate in 1 of 2 sub-studies Patients must have received at least 1 prior hormonal regimen and at least 6 months of a prior continuous endocrine therapy for locally advanced or metastatic disease Patients will be evaluated for treatment emergent adverse events AEs during study participation and toxicity will be assessed according to the National Cancer Institute NCI Common Terminology Criteria for Adverse Events Version 50
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