MedTrace Logo

Study to Assess Food Effect on Pharmacokinetics of Entinostat in Subjects With Breast Cancer or Non-Small Cell Lung Cancer

NCT01594398 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2021-11-19

No results posted yet for this study

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.

Conditions

Interventions

DRUG

entinostat

10 mg, po, q14 days, until progression or intolerable toxicity

DRUG

entinostat

10 mg, po, q14 days, until progression or intolerable toxicity

DRUG

Erlotinib

Erlotinib: NSCLC pts beginning C2D1,150 mg, po, qd.

DRUG

Erlotinib

Erlotinib: NSCLC pts beginning C2D1,150 mg, po, qd.

DRUG

Exemestane

Exemestane: Breast cancer pts beginning C2D1,25 mg, po, qd.

DRUG

Exemestane

Exemestane: Breast cancer pts beginning C2D1,25 mg, po, qd.

Sponsors & Collaborators

Principal Investigators

  • William McCulloch, M.D. · Syndax Pharmaceuticals

  • Howard A Burris, M.D. · Tennessee Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2014-04-30
Completion
2014-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01594398 on ClinicalTrials.gov