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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

This study has been withdrawn prior to enrollment.
(This study has been transfered from a sponsored trial to an investigator initiated trial.)
Sponsor:
Information provided by:
Syndax Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00754312
First received: September 15, 2008
Last updated: February 2, 2010
Last verified: February 2010
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
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

Resource links provided by NLM:

U.S. FDA Resources

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
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

  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

Locations
United States, Indiana
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
  More Information

No publications provided

Responsible Party: Judy Billingsley, Clinical Program Manager, Syndax Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00754312     History of Changes
Other Study ID Numbers: SNDX-275-0302
Study First Received: September 15, 2008
Last Updated: February 2, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Syndax Pharmaceuticals:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 22, 2013