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

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: SNDX-275

• Registration Number: NCT00754312
• Lead Sponsor: Syndax Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-09-15
• Study First Submitted QC: 2008-09-15
• Study First Posted: 2008-09-17
• Primary Completion: 2009-02-28
• Study Completion: 2009-02-28
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-01
• Last Update Posted: 2022-06-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 1

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	SNDX-275	ER negative and/or PR negative histology
1	SNDX-275	ER positive
3	SNDX-275	triple negative histology (for ER, PR, HER-2)

Primary Outcome Measures

Name	Time	Method
Evaluate changes in the expression of targeted biomarkers in invasive breast cancer tissue before and after SNDX-275 administration	14 days

Secondary Outcome Measures

Name	Time	Method
Evaluate safety and tolerability of SNDX-275 as measured by adverse events and changes in laboratory safety parameters	14 days
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

Trial Locations

Locations (1)

Monet Bowling, MD; 🇺🇸 Indianapolis, Indiana, United States