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Sponsored by: |
Syndax Pharmaceuticals |
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Information provided by: | Syndax Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00754312 |
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 |
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 |
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
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Drug: SNDX-275 |
2: Experimental
ER negative and/or PR negative histology
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Drug: SNDX-275 |
3: Experimental
triple negative histology (for ER, PR, HER-2)
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Drug: SNDX-275 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contact: Judy Billingsley | 781-419-1408 | jbillingsley@syndax.com |
United States, Indiana | |
Monet Bowling, MD | Recruiting |
Indianapolis, Indiana, United States |
Principal Investigator: | Monet Bowling, MD | Indiana University |
Study Chair: | Andrew Baildam, MD | Christie Hospital, UK |
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 |
breast cancer |
Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site |