Study to Assess Food Effect on Pharmacokinetics of Entinostat in Subjects With Breast Cancer or Non-Small Cell Lung Cancer
Condition: Lung Cancer; Non Small Cell Lung Cancer (NSCLC); Breast Cancer; Estrogen Receptor Breast Cancer
MeSH terms: Breast Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of food on the pharmacokinetics (PK) of
      the experimental drug, entinostat, in women with breast cancer and men and women with
      non-small cell lung cancer. The safety and tolerability of entinostat will also be evaluated
      when entinostat is given by itself as well as with the approved drugs, exemestane (Aromasin®)
      or erlotinib (Tarceva®). A biomarker (chemical "marker" in the blood/tissue that may be
      related to your response to the study drug) will also be tested.
    

Detailed description: 
      This is Phase 1, randomized, open-label, study of entinostat. The study is designed to
      evaluate any food effect on the pharmacokinetics of entinostat.

      Patients will be randomized to receive entinostat with or without food on Cycle 1 Day 1
      (C1D1). Patients randomized to receive entinostat with food on C1D1 will receive a second
      dose of entinostat without food on Cycle 1 Day 15 (C1D15). Patients randomized to receive
      entinostat without food on C1D1 will receive a second dose of entinostat with food on C1D15.
      Each cycle in the study will be for 28 days duration. Blood samples will be obtained pre-dose
      and serial blood samples will be taken after each dose to assess pharmacokinetics. For Cycle
      2 and all subsequent cycles, all patients will continue to receive entinostat on Days 1 and
      15 of each cycle. Those with breast cancer will also receive exemestane orally once daily
      starting on Cycle 2 Day 1. Those with NSCLC will also receive erlotinib starting on Cycle 2
      Day 1.

      Patients will be assessed at screening and at pre-prescribed times during study enrollment
      using standard assessments. Patients will also be assessed for tumor response after each 2
      cycles. Patients will continue receiving study treatment until tumor progression or adverse
      events occur which necessitate discontinuing therapy as determined by the Investigator.
    

Intervention name(s): entinostat; entinostat; Erlotinib; Erlotinib; Exemestane; Exemestane
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 10 mg, po, q14 days, until progression or intolerable toxicity; 10 mg, po, q14 days, until progression or intolerable toxicity; Erlotinib: NSCLC pts beginning C2D1,150 mg, po, qd.; Erlotinib: NSCLC pts beginning C2D1,150 mg, po, qd.; Exemestane: Breast cancer pts beginning C2D1,25 mg, po, qd.; Exemestane: Breast cancer pts beginning C2D1,25 mg, po, qd.
Other intervention name(s): SNDX-275, MS-275; SNDX-275, MS-275; Tarceva; Tarceva; Aromasin; Aromasin
Intervention MeSH terms: Erlotinib Hydrochloride; Exemestane; Entinostat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: carcinoma,non small cell lung; lung diseases; lung neoplasms; Respiratory; Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Respiratory Tract Diseases; Erlotinib; Protein Kinase Inhibitors; Breast Neoplasms; Neoplasms; Breast Diseases; Exemestane; Aromatase Inhibitors