An Open Label Study to Evaluate the Safety, Tolerability and Effect on Tumor Response of R1507 in Combination With Letrozole in Postmenopausal Women With Advanced Breast Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 主要终点
- Objective Tumor Response (Part 2)
研究概览
简要总结
This study aim was to determine the safety and efficacy of R1507 in combination with letrozole in patients with advanced breast cancer. In the first part of the study a cohort of patients with advanced breast cancer received letrozole 2.5mg po daily in combination with R1507 16mg/kg every 3 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •postmenopausal female patients;
- •stage IV or locally advanced breast cancer;
- •measurable disease;
- •letrozole failure (Part 2);
- •Eastern Cooperative Oncology Group (ECOG) performance status <=2.
排除标准
- •previous chemotherapy for metastatic breast cancer;
- •concurrent antibody or immunotherapy for advanced disease, within 4 weeks prior to receipt of study drug;
- •history of primary malignancy in 5 years prior to study, excluding adequately treated basal or squamous cell cancer of skin, or cancer in situ of cervix;
- •concurrent radiotherapy, or radiotherapy within 28 days prior to receipt of study drug.
研究组 & 干预措施
R1507 in Combination With Letrozole
Participants received a full daily dose of 2.5 mg of orally administered Letrozole along with 16 mg/kg of intravenous R1507 administered q3w, and observed for dose limiting toxicity for the first 2 cycles of treatment.
干预措施: RG1507 (Drug)
R1507 in Combination With Letrozole
Participants received a full daily dose of 2.5 mg of orally administered Letrozole along with 16 mg/kg of intravenous R1507 administered q3w, and observed for dose limiting toxicity for the first 2 cycles of treatment.
干预措施: Letrozole (Drug)
结局指标
主要结局
Objective Tumor Response (Part 2)
时间窗: Up to 14 months
次要结局
- Progression-free Survival (Part 2)(Up to 14 months)
- Pharmacokinetics (PK) Profile (Part 2)(Up to 14 months)
- Number of Participants With Adverse Events (Part 2)(Up to 14 months)