A Phase I, Multicenter, Open Label Study on the Effects of SNDX-275 on Expression of Biomarkers in Subjects With Newly Diagnosed Breast Cancer
Stopped early · Phase 1
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT00754312
- Run by
- Syndax Pharmaceuticals
- People needed
- 1
- Starts
- 2008-06-01
- Expected to finish
- 2009-02-28
- Last updated by the study team
- 2022-06-06
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Monet Bowling, MD — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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