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A Phase I, Multicenter, Open Label Study on the Effects of SNDX-275 on Expression of Biomarkers in Subjects With Newly Diagnosed Breast Cancer


Phase 1
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

A Phase I, Multicenter, Open Label Study on the Effects of SNDX-275 on Expression of Biomarkers in Subjects With Newly Diagnosed Breast Cancer

Inclusion Criteria


Inclusion criteria:

- Is scheduled for breast biopsy due to a suspicious mass palpable or ≥1 cm on
mammogram

- Must be able to receive two doses of study medication 7 days apart prior to surgery

- Has histologically confirmed invasive breast cancer with ER positive, ER and/or PR
negative histology or triple negative (for ER, PR, HER-2) histology

- Has an ECOG performance status ≤ 2

- Has no clinically significant laboratory or cardiac abnormalities

- Has a negative serum pregnancy test at Screening as is either post menopausal,
sterile or willing to use an approved method of contraception.

- Is able to swallow and retain oral medication

Exclusion criteria:

- Has a concomitant medical condition that precludes adequate study treatment
compliance or assessment, such as: a.
Bleeding disorders that would increase risks of additional core biopsy for biomarkers
b. Morbid obesity

- Is currently receiving treatment with a medication on the prohibited medication list

- Has allergy to benzamides or inactive components of study drug

- Is participating in another clinical trial or has received another investigational
agent within 30 days prior to informed consent

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

Evaluate changes in the expression of targeted biomarkers in invasive breast cancer tissue before and after SNDX-275 administration

Outcome Time Frame:

14 days

Safety Issue:

No

Principal Investigator

Monet Bowling, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University

Authority:

United States: Food and Drug Administration

Study ID:

SNDX-275-0302

NCT ID:

NCT00754312

Start Date:

June 2008

Completion Date:

April 2009

Related Keywords:

  • Breast Cancer
  • breast cancer
  • Breast Neoplasms

Name

Location

Monet Bowling, MD Indianapolis, Indiana