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

NCT00754312 | Terminated Phase 1

• 1 other identifier: SNDX-275-0302
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast cancer

Outcome Measures

Primary Outcomes (1)

• Evaluate changes in the expression of targeted biomarkers in invasive breast cancer tissue before and after SNDX-275 administration

  14 days

Secondary Outcomes (2)

• 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

• Evaluate safety and tolerability of SNDX-275 as measured by adverse events and changes in laboratory safety parameters

  14 days

Study Arms (3)

1

EXPERIMENTAL

ER positive

Drug: SNDX-275

2

EXPERIMENTAL

ER negative and/or PR negative histology

Drug: SNDX-275

3

EXPERIMENTAL

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

Drug: SNDX-275

Interventions

SNDX-275 DRUG

1; 2; 3

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Syndax Pharmaceuticals: lead

Study Sites (1)

Monet Bowling, MD

Indianapolis, Indiana, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

entinostat

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Monet Bowling, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

• Andrew Baildam, MD

  Christie Hospital, UK

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2008
• First Posted: September 17, 2008
• Study Start: June 1, 2008
• Primary Completion: February 28, 2009
• Study Completion: February 28, 2009
• Last Updated: June 6, 2022

Record last verified: 2022-06

Locations

US (1)