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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00754312
• Other study ID #: SNDX-275-0302
• Status: Terminated
• Phase: Phase 1
• Start date: June 2008
• Est. completion date: February 28, 2009

Study information

• Verified date: June 2022
• Source: Syndax Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: February 28, 2009
• Est. primary completion date: February 28, 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• SNDX-275

Locations

Country	Name	City	State
United States	Monet Bowling, MD	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Syndax Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate changes in the expression of targeted biomarkers in invasive breast cancer tissue before and after SNDX-275 administration		14 days
Secondary	Evaluate changes in gene and/or protein expression of exploratory biomarkers in invasive breast cancer tissue before and after SNDX-275 administration, as tissue sample permits.		14 days
Secondary	Evaluate safety and tolerability of SNDX-275 as measured by adverse events and changes in laboratory safety parameters		14 days