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Clinical Trial NCT00754312 for Breast Cancer is terminated. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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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 Phase 1 1 Biomarker-Driven Open-Label

Terminated
Clinical Trial NCT00754312 is designed to study Other for Breast Cancer. It is a Phase 1 interventional study that is terminated, having started on June 1, 2008, with plans to enroll 1 participants. Led by Syndax Pharmaceuticals, it is expected to complete by February 28, 2009. The latest data from ClinicalTrials.gov was last updated on June 6, 2022.
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.
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

Conditions
Breast Cancer
Other Study IDs
  • SNDX-275-0302
NCT ID Number
NCT00754312
Start Date (Actual)
2008-06
Last Update Posted
2022-06-06
Completion Date (Estimated)
2009-02-28
Enrollment (Estimated)
1
Study Type
Interventional
PHASE
Phase 1
Status
Terminated
Keywords
breast cancer
Primary Purpose
Other
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Experimental1
ER positive
SNDX-275
Experimental2
ER negative and/or PR negative histology
SNDX-275
Experimental3
triple negative histology (for ER, PR, HER-2)
SNDX-275
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Evaluate changes in the expression of targeted biomarkers in invasive breast cancer tissue before and after SNDX-275 administration
14 days
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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.
14 days
Evaluate safety and tolerability of SNDX-275 as measured by adverse events and changes in laboratory safety parameters
14 days
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
  • 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

  • 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
Syndax Pharmaceuticals logoSyndax Pharmaceuticals
No contact data.
1 Study Locations in 1 Countries

Indiana

Monet Bowling, MD, Indianapolis, Indiana, United States