Expired Study
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Indianapolis, Indiana


Purpose:

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.


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


Study is Available At:


Original ID:

SNDX-275-0302


NCT ID:

NCT00754312


Secondary ID:


Study Acronym:


Brief 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


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


Overall Status:

Withdrawn


Study Phase:

Phase 1


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Syndax Pharmaceuticals


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:

This study has been transfered from a sponso


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

30


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Monet Bowling, MD
Principal Investigator
Indiana University

Study Dates

Start Date:June 2008
Completion Date:April 2009
Completion Type:Anticipated
Primary Completion Date:April 2009
Primary Completion Type:Anticipated
Verification Date:February 2010
Last Changed Date:February 2, 2010
First Received Date:September 15, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Evaluate safety and tolerability of SNDX-275 as measured by adverse events and changes in laboratory safety parameters
Time Frame:14 days
Safety Issues:True
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Evaluate changes in the expression of targeted biomarkers in invasive breast cancer tissue before and after SNDX-275 administration
Time Frame:14 days
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:SNDX-275
Arm Name:1

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:ER positive
Study Arm Type:Experimental
Arm Name:2
Description:ER negative and/or PR negative histology
Study Arm Type:Experimental
Arm Name:3
Description:triple negative histology (for ER, PR, HER-2)

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Syndax Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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