NCT01594398

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

A Phase I Study to Assess the Food Effect on the Pharmacokinetics of Entinostat in Postmenopausal Women With Locally Recurrent or Metastatic ER+ Breast Cancer and Men and Women With Progressive Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Syndax Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer
• Non Small Cell Lung Cancer (NSCLC)
• Breast Cancer
• Estrogen Receptor Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-05-01
• Primary completion: 2014-04-01
• Completion: 2014-05-01
• First posted: 2012-05-09
• Last updated: 2021-11-19

Locations

3 sites across 1 country: United States