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

• Status: Withdrawn
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

The primary objective of the study is to evaluate changes in the expression of targeted biomarkers in invasive breast cancer tissue before and after SNDX-275 administration.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Syndax Pharmaceuticals
• Treatments: Entinostat

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