A Study of OP-1250 in Combination with the CDK4/6 Inhibitor Palbociclib in Adult Subjects with Advanced or Metastatic hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative) Breast Cancer

Phase 1

Recruiting

• Conditions: Breast Cancer; Cancer - Breast

• Registration Number: ACTRN12621001419853
• Lead Sponsor: Olema Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-21
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Hormone receptor-positive (HR+)/ human epidermal growth factor receptor 2-negative (HER2-) disease, as determined in the most recently obtained archival tumor tissue sample from a metastatic site, using locally accepted criteria by the local pathology report.
2. Willing and able to participate and comply with all study requirements and to provide signed and dated informed consent prior to initiation of any study procedures.
3. Histologically- or cytologically-confirmed locally advanced or MBC for which standard curative measures do not exist.
4. Life expectancy more than 6 months, as judged by the Investigator.

Exclusion Criteria

1. Prior or concurrent malignancy whose natural history or treatment may interfere with the safety or efficacy assessment of the investigational regimen as determined by the medical monitor.
2. Known impaired cardiac function or clinically significant cardiac disease, such as ventricular arrhythmia requiring therapy, congestive heart failure (New York Heart Association Functional Classification Class 2B-4), and uncontrolled hypertension (defined as systolic blood pressure greater than 150 mm Hg and/or diastolic blood pressure greater than 100 mm Hg while on anti-hypertensive medications).
3. Myocardial infarction or unstable angina within 6 months prior to the first administration of study drug.
4. History of cerebral vascular disease within 6 months prior to the first administration of study drug.

Study & Design

• Study Type: Interventional
• Study Design: Not specified