Status:
COMPLETED
Study of the Effect of the Addition of SNDX-275 (Entinostat) to Continued Aromatase Inhibitor (AI) Therapy in Postmenopausal Women With ER+ Breast Cancer Whose Disease is Progressing
Lead Sponsor:
Syndax Pharmaceuticals
Conditions:
ER+ Breast Cancer
Eligibility:
FEMALE
Phase:
PHASE2
Brief Summary
The addition of entinostat 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 th...
Eligibility Criteria
Inclusion
- Postmenopausal female patients.
- Histologically or cytologically confirmed estrogen receptor-positive (ER+) breast cancer.
- Progressive disease (PD) after at least 3 months on treatment with a 3rd generation AI in the advanced disease setting as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- At least 1 measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral computed tomography (CT) scan with the last imaging performed within 4 weeks prior to study entry. If there is only one measurable lesion and it is located in previously irradiated field, it must have demonstrated progression according to RECIST criteria.
- Eastern Cooperative Oncology Group (ECOG) 0-1.
- Laboratory parameters:
- Hemoglobin ≥ 9.0 g/dL; platelets ≥ 100 x10\^9/L; absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L without the use of hematopoietic growth factors.
- Creatinine less than 2.5 times the upper limit of normal for the institution.
- aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 2.5 times the upper limit of normal for the institution.
- Able to understand and give written informed consent and comply with study procedures.
Exclusion
- Discontinuation of AI therapy prior to study entry.
- Less than 3 months treatment with most recent AI.
- Rapidly progressive, life-threatening metastases, including any of the following:
- Symptomatic lymphangitic metastases.
- Patients with known active brain or leptomeningeal involvement.
- More than one prior chemotherapy for metastatic disease.
- Any chemotherapy within 3 months prior to study.
- Radiotherapy to measurable lesion within 2 months prior to study.
- Bisphosphonates initiated within 4 weeks prior to study start.
- Allergy to benzamides or inactive components of study drug.
- Previous treatment with entinostat or any other histone deacetylase (HDAC) inhibitor including valproic acid.
- Patient is currently receiving treatment with any agent listed on the prohibited medication list such as valproic acid or other systemic cancer agents
- Any concomitant medical condition that precludes adequate study treatment compliance or assessment, or increases patient risk in the opinion of the investigator:
- Myocardial infarction or arterial thromboembolic events within 6 months, or experiencing severe or unstable angina, New York Heart Association (NYHA) Class III or IV disease and a QTc interval \>0.47 second.
- Uncontrolled heart failure or hypertension, uncontrolled diabetes mellitus, uncontrolled systemic infection,
- Other active malignancy within 5 years excluding basal cell carcinoma or cervical intraepithelial neoplasia \[CIN / cervical carcinoma in situ\] or melanoma in situ).
- Patient currently is enrolled in (or completed within 30 days before study drug administration) another investigational drug study.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 24 2009
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00828854
Start Date
October 1 2008
End Date
November 24 2009
Last Update
June 30 2022
Active Locations (6)
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1
St. Vincent's University Hospital
Dublin, Ireland
2
The University of Birmingham
Birmingham, United Kingdom
3
Velindre Hospital - Whitchurch
Cardiff, United Kingdom
4
Whiston Hospital; Clatterbridge Centre for Oncology
Liverpool, United Kingdom