Status:
TERMINATED
A Phase I, Multicenter, Open Label Study on the Effects of SNDX-275 on Expression of Biomarkers in Subjects With Newly Diagnosed Breast Cancer
Lead Sponsor:
Syndax Pharmaceuticals
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2009
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00754312
Start Date
June 1 2008
End Date
February 28 2009
Last Update
June 6 2022
Active Locations (1)
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1
Monet Bowling, MD
Indianapolis, Indiana, United States