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

Syndax Pharmaceuticals

Status and phase: Terminated; Phase 1

Conditions: Breast Cancer

Treatments: Drug: SNDX-275

Study type: Interventional

Funder types: Industry

Identifiers

NCT00754312

SNDX-275-0302

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 3 patient groups

1

Experimental group

Description:

ER positive

Treatment:

Drug: SNDX-275

2

Experimental group

Description:

ER negative and/or PR negative histology

Treatment:

Drug: SNDX-275

3

Experimental group

Description:

triple negative histology (for ER, PR, HER-2)

Treatment:

Drug: SNDX-275