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Sponsored by: |
Syndax Pharmaceuticals |
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Information provided by: | Syndax Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00828854 |
The addition of SNDX-275 to an AI will result in a maximal abrogation of estrogen receptor-α mediated activity and inhibit mechanisms of resistance to the aromatase inhibitor.
It is hypothesized that SNDX-275 with continued AI will increase the estimated AI clinical benefit rate (CBR) from 5% to 25% with an acceptable safety profile.
Condition | Intervention | Phase |
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ER+ Breast Cancer |
Drug: entinostat (SNDX-275) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, Multicenter Study of the Effect of the Addition of SNDX-275 to Continued Aromatase Inhibitor (AI) Therapy in Postmenopausal Women With ER+ Breast Cancer Whose Disease is Progressing |
Estimated Enrollment: | 25 |
Study Start Date: | April 2008 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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treatment: Experimental
Continued treatment with same AI at labeled dose and schedule, plus Entinostat (5mg PO every week)
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Drug: entinostat (SNDX-275)
5 mg PO every week
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Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Laboratory parameters:
Exclusion Criteria:
Rapidly progressive, life-threatening metastases, including any of the following:
Any concomitant medical condition that precludes adequate study treatment compliance or assessment, or increases patient risk in the opinion of the investigator:
Ireland | |
St. Vincent's University Hospital | |
Dublin, Ireland | |
United Kingdom | |
Christie Hospital, Manchester Breast Centre | |
Manchester, United Kingdom | |
University College London Hospitals | |
London, United Kingdom | |
Velindre Hospital - Whitchurch | |
Cardiff, United Kingdom | |
The University of Birmingham | |
Birmingham, United Kingdom | |
Whiston Hospital; Clatterbridge Centre for Oncology | |
Liverpool, United Kingdom |
Responsible Party: | Syndax Pharmaceuticals, Inc. ( Judy Billingsley, RN, BSN, OCN ) |
Study ID Numbers: | SNDX-275-0303 |
Study First Received: | January 23, 2009 |
Last Updated: | July 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00828854 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; Ireland: Irish Medicines Board |
breast cancer estrogen receptor postive |
Estrogens Skin Diseases Breast Neoplasms Aromatase Inhibitors Breast Diseases |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Skin Diseases Breast Neoplasms |
Enzyme Inhibitors Aromatase Inhibitors Pharmacologic Actions Breast Diseases |