Clinical Trials /

Drug-Drug Interaction Study of Entinostat and Exemestane in Postmenopausal Women With ER+ Breast Cancer

NCT02820961

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Unknown status

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT02820961

Trial Eligibility

Document

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

DrugSynonymsArms
entinostatSNDX-275, MS-275Cohort 1
exemestaneAromasin, FCE-24304Cohort 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

NameTypeDescriptionInterventions
Cohort 1Active ComparatorCohort 1 will evaluate exemestane's effect on the PK of entinostat. Each treatment cycle is 28 days.
  • entinostat
  • exemestane
Cohort 2Active ComparatorCohort 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
  • exemestane

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