- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00754312
A Phase I, Multicenter, Open Label Study on the Effects of SNDX-275 on Expression of Biomarkers in Subjects With Newly Diagnosed Breast Cancer
June 1, 2022 updated by: Syndax Pharmaceuticals
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
1
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Indiana
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Indianapolis, Indiana, United States
- Monet Bowling, MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
ER positive
|
|
EXPERIMENTAL: 2
ER negative and/or PR negative histology
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|
EXPERIMENTAL: 3
triple negative histology (for ER, PR, HER-2)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluate changes in the expression of targeted biomarkers in invasive breast cancer tissue before and after SNDX-275 administration
Time Frame: 14 days
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
14 days
|
Evaluate safety and tolerability of SNDX-275 as measured by adverse events and changes in laboratory safety parameters
Time Frame: 14 days
|
14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Andrew Baildam, MD, Christie Hospital, UK
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (ACTUAL)
February 28, 2009
Study Completion (ACTUAL)
February 28, 2009
Study Registration Dates
First Submitted
September 15, 2008
First Submitted That Met QC Criteria
September 15, 2008
First Posted (ESTIMATE)
September 17, 2008
Study Record Updates
Last Update Posted (ACTUAL)
June 6, 2022
Last Update Submitted That Met QC Criteria
June 1, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SNDX-275-0302
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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