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

This study is currently recruiting participants.

Verified by Syndax Pharmaceuticals, September 2008

Sponsored by:	Syndax Pharmaceuticals
Information provided by:	Syndax Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00754312

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.

Condition	Intervention	Phase
Breast Cancer	Drug: SNDX-275	Phase I

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Bio-availability Study
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

Further study details as provided by Syndax Pharmaceuticals:

Primary Outcome Measures:

Evaluate changes in the expression of targeted biomarkers in invasive breast cancer tissue before and after SNDX-275 administration [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Evaluate safety and tolerability of SNDX-275 as measured by adverse events and changes in laboratory safety parameters [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	June 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental ER positive	Drug: SNDX-275
2: Experimental ER negative and/or PR negative histology	Drug: SNDX-275
3: Experimental triple negative histology (for ER, PR, HER-2)	Drug: SNDX-275

Eligibility

Ages Eligible for Study:	18 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754312

Contacts

Contact: Judy Billingsley

781-419-1408

jbillingsley@syndax.com

Locations

United States, Indiana
Monet Bowling, MD	Recruiting
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

More Information

Responsible Party:	Syndax Pharmaceuticals, Inc. ( Judy Billingsley, Clinical Program Manager )
Study ID Numbers:	SNDX-275-0302
Study First Received:	September 15, 2008
Last Updated:	September 15, 2008
ClinicalTrials.gov Identifier:	NCT00754312
Health Authority:	United States: Food and Drug Administration

Keywords provided by Syndax Pharmaceuticals:

breast cancer

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 13, 2009