We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00754312
Recruitment Status : Terminated
First Posted : September 17, 2008
Last Update Posted : June 6, 2022
Sponsor:
Information provided by (Responsible Party):
Syndax Pharmaceuticals

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Breast Cancer Drug: SNDX-275 Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : June 2008
Actual Primary Completion Date : February 28, 2009
Actual Study Completion Date : February 28, 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 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. [ 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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00754312


Locations
Layout table for location information
United States, Indiana
Monet Bowling, MD
Indianapolis, Indiana, United States
Sponsors and Collaborators
Syndax Pharmaceuticals
Investigators
Layout table for investigator information
Principal Investigator: Monet Bowling, MD Indiana University
Study Chair: Andrew Baildam, MD Christie Hospital, UK
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Syndax Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00754312    
Other Study ID Numbers: SNDX-275-0302
First Posted: September 17, 2008    Key Record Dates
Last Update Posted: June 6, 2022
Last Verified: June 2022
Keywords provided by Syndax Pharmaceuticals:
breast cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Entinostat
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action