Status:
COMPLETED
A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer
Lead Sponsor:
Olema Pharmaceuticals, Inc.
Conditions:
Hormone Receptor Positive Breast Carcinoma
HER2-negative Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 and/or metastatic ...
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) and/or rec...
Eligibility Criteria
Inclusion
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- 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
- Must not have received prior oral endocrine therapy \< 2 weeks prior to first dose
- Must not have received prior, chemotherapy in 2 weeks or within 5 half-lives whichever is earlier, antibody therapy within 4 weeks or investigational therapy within 4 weeks or 5 half-lives whichever is earlier, prior to the first dose
- Adequate hepatic function
- Adequate renal function
- Normal coagulation panel
- Willingness to use effective contraception
Exclusion
- Gastrointestinal disease
- Significant renal disease
- Significant cardiovascular disease
- Significant ECG abnormalities
- Ongoing systemic bacterial, fungal, or viral infection (requiring antimicrobial therapy)
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
August 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2024
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT04505826
Start Date
August 13 2020
End Date
July 30 2024
Last Update
August 24 2025
Active Locations (19)
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1
UCLA Hematology/Oncology
Los Angeles, California, United States, 90404
2
University of Colorado
Aurora, Colorado, United States, 80045
3
University of Miami, Sylvester Comprehensive Cancer Center
Deerfield Beach, Florida, United States, 33442
4
Advent Health
Orlando, Florida, United States, 32804