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

Sponsor
Syndax Pharmaceuticals (Industry)
Overall Status
Terminated
CT.gov ID
NCT00754312
Collaborator
(none)
1
Enrollment
1
Location
3
Arms
8.9
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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
Study Start Date :
Jun 1, 2008
Actual Primary Completion Date :
Feb 28, 2009
Actual Study Completion Date :
Feb 28, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Evaluate changes in the expression of targeted biomarkers in invasive breast cancer tissue before and after SNDX-275 administration [14 days]

Secondary Outcome Measures

  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. [14 days]

  2. Evaluate safety and tolerability of SNDX-275 as measured by adverse events and changes in laboratory safety parameters [14 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Monet Bowling, MD Indianapolis Indiana United States

Sponsors and Collaborators

  • Syndax Pharmaceuticals

Investigators

  • Principal Investigator: Monet Bowling, MD, Indiana University
  • Study Chair: Andrew Baildam, MD, Christie Hospital, UK

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Syndax Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00754312
Other Study ID Numbers:
  • SNDX-275-0302
First Posted:
Sep 17, 2008
Last Update Posted:
Jun 6, 2022
Last Verified:
Jun 1, 2022
Keywords provided by Syndax Pharmaceuticals
breast cancer
Additional relevant MeSH terms:
Breast Neoplasms
Entinostat

Study Results

No Results Posted as of Jun 6, 2022