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TerminatedNCT00754312Updated Jun 6, 2022

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

A Phase 1 interventional study of SNDX-275 in Breast Cancer, sponsored by Syndax Pharmaceuticals. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-06.

Sponsored by Syndax Pharmaceuticals · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
1
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Breast Cancer

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Keywords

  • breast cancer
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 1 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Syndax Pharmaceuticals is the lead sponsor of 29 studies on the registry; 3 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 6 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • 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

Interventions

  • DrugSNDX-275
06

What researchers measure

Primary outcomes

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

    Time frame: 14 days

Secondary outcomes

  1. 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

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

    Time frame: 14 days

07

Study locations

1 site
  • Monet Bowling, MD
    Indianapolis, Indiana, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00754312
Lead sponsor
Syndax Pharmaceuticals
Responsible party
Sponsor
First posted
Sep 17, 2008
Start date
Jun 2008
Primary completion
Feb 28, 2009
Completion
Feb 28, 2009
Last update
Jun 6, 2022

Study contacts

Monet Bowling, MD
principal investigator · Indiana University
Andrew Baildam, MD
study chair · Christie Hospital, UK

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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