NCT01658176撤回2 期
An Open-Label Randomized Phase 2 Study Of PF-04691502 (PI3K/mTOR Inhibitor) In Combination With Exemestane Compared With Exemestane Alone In Patients With Estrogen Receptor Positive, Her-2 Negative Advanced Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- Progression-Free Survival
研究概览
简要总结
PF-04691502 is an inhibitor of PI3K and mTOR kinase. Exemestane is an aromatase inhibitor for the treatment of advanced breast cancer in women whose disease has progressed following tamoxifen therapy. The combination of PF-04691502 and exemestane might mitigate resistance to hormonal therapy and result in greater clinical benefit than exemestane alone in women with estrogen receptor positive 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
- None
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
- •Inoperable estrogen receptor positive, Her-2 negative advanced breast cancer
- •Previously treated with an aromatase inhibitor
- •Primary or secondary hormone resistance
- •Acceptable glucose control, bone marrow, liver and kidney function
排除标准
- •Inflammatory breast carcinoma
- •Prior therapy with an agent active on PI3K, Akt, and/or mTOR
- •Known hypersensitivity to exemestane
- •Significant gastrointestinal abnormalities which may impair intake, transit, or absorption of the study drugs
- •Current or anticipated need for food or drugs that are known inhibitors or inducers of CYP3A4
研究组 & 干预措施
PF-04691502 + Exemestane
Experimental
PF-04691502 in combination with Exemestane
干预措施: PF-04691502 (Drug)
PF-04691502 + Exemestane
Experimental
PF-04691502 in combination with Exemestane
干预措施: Exemestane (Drug)
Exemestane
Active Comparator
Exemestane alone
干预措施: Exemestane (Drug)
结局指标
主要结局
Progression-Free Survival
时间窗: Baseline up to month 12
次要结局
- Objective tumor response using RECIST(Baseline up to month 12)
- Duration of tumor response(Baseline up to month 12)
- Clinical benefit response(Baseline up to month 12)
- Overall Survival(2 years)
- Biomarkers related to PI3K/mTOR signal deregulation and markers of cellular proliferation and apoptosis in primary tumor tissue(Baseline)
- Maximum concentration (Cmax) of single dose of PF-04691502(Day 2 Pre-dose, and 1 , 2, 4 and 24 hours post-dose)
- Maximum concentration (Cmax) of single dose exemestane(Day 1 pre-dose, and 1, 2, 4 and 24 hours post-dose)
- Maximum concentration (Cmax) of PF-04691502 and exemestane when administered in combination(Day 8 Pre-dose, and 1, 2, 4 and 24 hours post-dose, Weel 5, 9, 13, 17, 21, and 25)
- Pharmacodynamic endpoints including serum glucose, insulin, HbA1c, cholesterol and triglycerides(12 months)
- Heath related quality of life measured by Functional Assessment of Cancer Therapy- Breast(12 months)
- Area under the plasma concentration versus time curve (AUC) of single dose of PF-04691502(Day 2 Pre-dose, and 1 , 2, 4 and 24 hours post-dose)
- Area under the plasma concentration versus time curve (AUC) of single dose exemestane(Day 1 pre-dose, and 1, 2, 4 and 24 hours post-dose)
- Area under the plasma concentration versus time curve (AUC) of PF-04691502 and exemestane when administered in combination(Day 8 Pre-dose, and 1, 2, 4 and 24 hours post-dose, Weel 5, 9, 13, 17, 21, and 25)
研究者
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