A Phase 2, Randomized, Double-Blind, Multicenter Study of Exemestane With and Without SNDX-275 in Postmenopausal Women With Locally Recurrent or Metastatic Estrogen Receptor-Positive Breast Cancer, Progressing on Treatment With a Non-Steroidal Aromatase Inhibitor
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 38
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Exemestane 25 mg + Entinostat 5 mg
Exemestane (Aromasin®) 25 mg tablets orally once daily plus an entinostat 5 mg tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.
干预措施: entinostat (Drug)
Exemestane 25 mg + Entinostat 5 mg
Exemestane (Aromasin®) 25 mg tablets orally once daily plus an entinostat 5 mg tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.
干预措施: exemestane (Drug)
Exemestane 25 mg + Placebo
Exemestane (Aromasin®) 25 mg tablets orally once daily plus a placebo-matching entinostat tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.
干预措施: exemestane (Drug)
Exemestane 25 mg + Placebo
Exemestane (Aromasin®) 25 mg tablets orally once daily plus a placebo-matching entinostat tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.
干预措施: Placebo (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: From date of randomization to discontinuation due to disease progression or death up to primary completion date (Median follow-up 6 months)
PFS is defined as the number of months from the date of randomization to the earlier of progressive disease (PD) or death due to any cause.
次要结局
- Objective Response Rate (ORR)(From date of randomization to discontinuation due to disease progression or intolerable Adverse Event (AE) up to primary completion date (Median follow-up 6 months))
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(First dose to within 30 days of last dose of study drug (Up to Approximately 2 Years))
- Clinical Benefit Rate (CBR)(From date of randomization to discontinuation due to disease progression or intolerable AE up to primary completion date (Median follow-up 6 months))