Description:
The purpose of this study is to determine the effect of exemestane on the pharmacokinetics
(PK) of entinostat and to determine the effect of entinostat on the PK of exemestane in
patients with locally recurrent or metastatic estrogen receptor positive (ER+) breast cancer.
Additionally, this study will evaluate the safety and tolerability of entinostat in
combination with exemestane, and assess the effectiveness of entinostat in combination with
exemestane in terms of best overall response and overall survival.
Title
- Brief Title: Drug-Drug Interaction Study of Entinostat and Exemestane in Postmenopausal Women With ER+ Breast Cancer
- Official Title: A Phase 1, Two-Cohort, Open-Label, Drug-Drug Interaction Study of Entinostat and Exemestane in Postmenopausal Women With Locally Recurrent or Metastatic ER+ Breast Cancer
Clinical Trial IDs
- ORG STUDY ID:
SNDX-275-0130
- NCT ID:
NCT02820961
Conditions
- Breast Cancer
- Estrogen Receptor Positive Breast Cancer
Interventions
Drug | Synonyms | Arms |
---|
entinostat | SNDX-275, MS-275 | Cohort 1 |
exemestane | Aromasin, FCE-24304 | Cohort 1 |
Purpose
The purpose of this study is to determine the effect of exemestane on the pharmacokinetics
(PK) of entinostat and to determine the effect of entinostat on the PK of exemestane in
patients with locally recurrent or metastatic estrogen receptor positive (ER+) breast cancer.
Additionally, this study will evaluate the safety and tolerability of entinostat in
combination with exemestane, and assess the effectiveness of entinostat in combination with
exemestane in terms of best overall response and overall survival.
Detailed Description
SNDX-275-0130 is a Phase 1, two-cohort, open-label, drug-drug interaction study of entinostat
and exemestane. All patients will be enrolled into one of two cohorts to receive either
entinostat monotherapy followed by entinostat plus exemestane (Cohort 1), or exemestane
monotherapy followed by exemestane plus entinostat (Cohort 2).
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Cohort 1 | Active Comparator | Cohort 1 will evaluate exemestane's effect on the PK of entinostat. Each treatment cycle is 28 days. | |
Cohort 2 | Active Comparator | 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. | |
Eligibility Criteria
Inclusion Criteria:
- Postmenopausal female patients
- 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:
- Rapidly progressive or life-threatening metastases
- 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
Maximum Eligible Age: | 85 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Cmax, maximum plasma concentration |
Time Frame: | Approximately 1 year |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Best overall tumor response |
Time Frame: | Approximately 2 years |
Safety Issue: | |
Description: | |
Measure: | Overall survival |
Time Frame: | Approximately 2 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Unknown status |
Lead Sponsor: | Syndax Pharmaceuticals |
Trial Keywords
- Breast Neoplasms
- Breast Diseases
- Exemestane
- Protein Kinase Inhibitors
- Aromatase Inhibitors
- entinostat
- Cancer of the Breast
- Metastatic Breast Cancer
- Hormone Receptor Positive Breast Cancer
- Estrogen Receptor
- ER+ Breast Cancer
- Breast Tumor
Last Updated
June 21, 2018