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

Part of paid clinical trials in Sarasota, Florida.

Sponsor
Syndax Pharmaceuticals
Study ID
NCT01594398
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • entinostat — DRUG
    10 mg, po, q14 days, until progression or intolerable toxicity
  • entinostat — DRUG
    10 mg, po, q14 days, until progression or intolerable toxicity
  • Erlotinib — DRUG
    Erlotinib: NSCLC pts beginning C2D1,150 mg, po, qd.
  • Erlotinib — DRUG
    Erlotinib: NSCLC pts beginning C2D1,150 mg, po, qd.
  • Exemestane — DRUG
    Exemestane: Breast cancer pts beginning C2D1,25 mg, po, qd.
  • Exemestane — DRUG
    Exemestane: Breast cancer pts beginning C2D1,25 mg, po, qd.

Study Details

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.

Key Dates

First listed
May 9, 2012
Start date
May 31, 2012
Status verified
Nov 2021
Primary completion
Apr 30, 2014
Completion
May 31, 2014

Study Design

Enrollment
14 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: entinostat C1D1 fed
    Entinostat: Beginning C1D1 fed; C1D15 fasted. Erlotinib: NSCLC pts beginning C2D1,150 mg, po, qd. Exemestane: Breast cancer pts beginning C2D1,25 mg, po, qd.
  • Experimental: entinostat C1D1 fasted
    Entinostat: Beginning C1D1 fasted; C1D15 fed. Erlotinib: NSCLC pts beginning C2D1,150 mg, po, qd. Exemestane: Breast cancer pts beginning C2D1,25 mg, po, qd.

Primary Outcome Measure

Difference in pharmacokinetics of entinostat when subjects fed or fasted [ Time Frame: C1D1 (sequential), D2, 4, 6, 8, 11; C1D15 (sequential), 16, 18, 20, 22 25; C2D1 ]

Locations (3)

FacilityCityStateZIPSite coordinators
Florida Cancer SpecialistsSarasotaFlorida34232-
Peggy and Charles Stephenson Cancer CenterOklahoma CityOklahoma73104-
Sarah Cannon Research InstituteNashvilleTennessee37203-

Find similar trials in Sarasota, FL

By condition
Breast cancerLung cancer
By specialty
OncologyBreast oncologyWomen's healthLung oncologyLung disease
By research site
Florida Cancer Specialists· Sarasota, FLPeggy and Charles Stephenson Cancer Center· Oklahoma City, OKSarah Cannon Research Institute· Nashville, TN

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