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

June 1, 2022 updated by: Syndax Pharmaceuticals
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States
        • Monet Bowling, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
ER positive
Drug: SNDX-275
EXPERIMENTAL: 2
ER negative and/or PR negative histology
Drug: SNDX-275
EXPERIMENTAL: 3
triple negative histology (for ER, PR, HER-2)
Drug: SNDX-275

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate changes in the expression of targeted biomarkers in invasive breast cancer tissue before and after SNDX-275 administration
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 14 days
14 days
Evaluate safety and tolerability of SNDX-275 as measured by adverse events and changes in laboratory safety parameters
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Syndax Pharmaceuticals

Investigators

  • Study Chair: Andrew Baildam, MD, Christie Hospital, UK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (ACTUAL)

February 28, 2009

Study Completion (ACTUAL)

February 28, 2009

Study Registration Dates

First Submitted

September 15, 2008

First Submitted That Met QC Criteria

September 15, 2008

First Posted (ESTIMATE)

September 17, 2008

Study Record Updates

Last Update Posted (ACTUAL)

June 6, 2022

Last Update Submitted That Met QC Criteria

June 1, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNDX-275-0302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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