Spots Global Cancer Trial Database for A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer
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 and/or Metastatic Hormone Receptor (HR)-Positive, HER2-negative Breast Cancer
Study ID: NCT04505826
Interventions
Study Description
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 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) and/or 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)-positive/human 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 5.0.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UCLA Hematology/Oncology, Los Angeles, California, United States
University of Colorado, Aurora, Colorado, United States
University of Miami, Sylvester Comprehensive Cancer Center, Deerfield Beach, Florida, United States
Advent Health, Orlando, Florida, United States
Florida Cancer Center, Sarasota, Florida, United States
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, Indiana, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Saint Luke's Hospital of Kansas City, Kansas City, Missouri, United States
Montefiore Medical Center, Bronx, New York, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Providence Portland Medical Center, Portland, Oregon, United States
OHSU Knight Cancer Institute, Portland, Oregon, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Macquarie University, Sydney, New South Wales, Australia
Westmead, Westmead, New South Wales, Australia
ICON Cancer Centre, Auchenflower, Queensland, Australia
Cancer Research South Australia, Adelaide, South Australia, Australia
Contact Details
Name: Mark Shilkrut, MD
Affiliation: Olema Pharmaceuticals, Inc.
Role: STUDY_DIRECTOR
Name: Gurpreet Mathauda-Sahota, PharmD
Affiliation: Olema Pharmaceuticals, Inc.
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
