Overview
Study to Evaluate Exemestane With and Without Entinostat (SNDX-275) in Treatment of Postmenopausal Women With Advanced Breast Cancer
Status:
Completed
Completed
Trial end date:
2012-11-26
2012-11-26
Target enrollment:
0
0
Participant gender:
Female
Female
Summary
The purpose of this study is to evaluate the safety and efficacy of entinostat in combination with exemestane in the treatment of advanced breast cancer.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Syndax PharmaceuticalsTreatments:
Entinostat
Exemestane
Criteria
Inclusion Criteria:- Postmenopausal female patients
- Histologically or cytologically confirmed estrogen receptor positive (ER+) breast
cancer
- Relapsed or progressed on prior treatment with aromatase inhibitor (AI)
- Metastatic disease must be measurable
- Patients receiving palliative radiation at the non-target lesions must have a 2 week
wash out period following completion of the treatment prior to enrollment
- Patient may have had one prior chemotherapy as part of first line therapy as long as
it was received before initiation of prior AI
- Eastern Cooperative Oncology Group (ECOG) performance status: 0 to 1
- Laboratory parameters: a)Hemoglobin ≥ 9.0 g/dL; platelets ≥ 100.0 x 10^9/L; Absolute
Neutrophil Count (ANC ≥) 1.5 x 10^9/L without the use of hematopoietic growth factors
b)Creatinine less than 2.5 times the upper limit of normal for the institution
c)Aspartate transaminase (AST) and alanine transaminase (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 Criteria:
- Relapse on treatment with non-steroidal AI after less than 12 months for patients in
the adjuvant setting
- Progressive disease after less than 3 months treatment with most recent AI for
patients with metastatic disease
- Rapidly progressive, life-threatening metastases
- Any palliative radiotherapy to the measurable lesion
- Previous treatment with SNDX-275 or any other histone deacetylase (HDAC) inhibitor
including valproic acid
- Allergy to benzamides or inactive components of the study drug
- A history of allergies to any active or inactive ingredients of exemestane
- Any concomitant medical condition that precludes adequate study treatment compliance
- Patient is currently enrolled in (or completed within 30 days before study drug
administration) another investigational drug study
- Patient is currently receiving treatment with valproic acid, Zolinza (vorinostat) or
any other HDAC inhibitor or deoxyribonucleic acid (DNA) methyltransferase inhibitor or
any systemic anticancer treatment (with the exception of Lupron)