Drug-Drug Interaction Study of Entinostat and Exemestane in Postmenopausal Women With ER+ Breast Cancer
NCT ID: NCT02820961
Last Updated: 2021-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
61 participants
INTERVENTIONAL
2016-06-29
2021-07-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The cohorts will enroll sequentially, meaning that Cohort 1 will enroll prior to Cohort 2. Cohort 1 will evaluate exemestane's effect on the PK of entinostat. Cohort 2 will evaluate entinostat's effect on the PK of exemestane. In both Cohorts, each treatment cycle will be 28 days. Patients will participate in only one cohort.
All patients will be assessed at Screening and at specified times during the conduct of the study using standard clinical and laboratory assessment. Patients will also be assessed for tumor response per standard of care after the Screening Period. Response to treatment will be assessed by computerized tomography (CT), magnetic resonance imaging (MRI) and bone scans as appropriate. Patients will continue receiving their appropriate cycles of study treatment until tumor progression or adverse events (AEs) occur which necessitate discontinuing therapy as determined by the Investigator.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort 1
Cohort 1 will evaluate exemestane's effect on the PK of entinostat. Each treatment cycle is 28 days.
entinostat
An orally available histone deacetylases inhibitor (HDAC)
exemestane
Aromatase inhibitor
Cohort 2
Cohort 2 will enroll when Cohort 1 enrollment is complete. Cohort 2 will evaluate entinostat's effect on the PK of exemestane. Each treatment cycle is 28 days.
entinostat
An orally available histone deacetylases inhibitor (HDAC)
exemestane
Aromatase inhibitor
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
entinostat
An orally available histone deacetylases inhibitor (HDAC)
exemestane
Aromatase inhibitor
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Histologically or cytologically confirmed ER+ breast cancer at initial diagnosis and have locally recurrent or metastatic disease that has progressed to where the patient is a candidate to receive exemestane as determined by the Investigator
* Patients receiving palliative radiation at the non-target lesions must be clinically stable prior to receiving the first dose of study treatment
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Patient must have acceptable, applicable laboratory requirements
* Patients may have a history of brain metastasis provided certain protocol criteria are met
* Able to understand and give written informed consent and comply with study procedures
Exclusion Criteria
* Inability to swallow oral medications or gastrointestinal (GI) malabsorption syndromes
* History of significant GI surgery as determined by Investigator
* A medical condition that precludes adequate study treatment or increases patient risk
* Currently enrolled in (or completed within 30 days prior to study drug administration) another investigational drug study
18 Years
85 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Syndax Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael Meyers, MD, PhD
Role: STUDY_DIRECTOR
Syndax Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sarah Cannon Research Institute HealthONE
Denver, Colorado, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SNDX-275-0130
Identifier Type: -
Identifier Source: org_study_id