A Phase Ib, Open-label, Two Arm Study of i.v. and Oral Panobinostat (LBH589) in Combination With i.v. Trastuzumab (Herceptin®) and i.v. Paclitaxel as Treatment for Adult Female Patients With HER2 Overexpressing Metastatic Breast Cancer (MBC)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Determine the maximum tolerated dose of oral panobinostat in combination with trastuzumab and paclitaxel. Determine the maximum tolerated dose of iv LBH in combination with trastuzumab and paclitaxel.
研究概览
简要总结
The primary purpose of this study is to identify the maximum tolerated dose (MTD) of both intravenous and oral panobinostat when given in combination with trastuzumab and paclitaxel. The study will evaluate safety and efficacy of the combination in adult female patients with HER2+ metastatic breast cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Age > 18 year old
- •Confirmed HER2+ metastatic breast cancer
- •Prior treatment and progression on trastuzumab
- •Patients must have adequate organ functions
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
排除标准
- •Patients who have had surgery within last 2 weeks prior to starting the treatment
- •Patients who receive concurrent therapy for brain metastases
- •Impaired heart function or clinically significant heart disease
- •Ongoing diarrhea
- •Liver or renal disease with impaired hepatic or renal functions
- •Concomitant use of any anti-cancer therapy or certain drugs
- •Female patients who are pregnant or breast feeding
- •Patients not willing to use an effective method of birth control Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
IV LBH589 + trastuzumab + paclitaxel
i.v. panobinostat
干预措施: IV LBH589 (Drug)
IV LBH589 + trastuzumab + paclitaxel
i.v. panobinostat
干预措施: trastuzumab (Drug)
IV LBH589 + trastuzumab + paclitaxel
i.v. panobinostat
干预措施: paclitaxel (Drug)
Oral LBH589 + trastuzumab + paclitaxel
oral panobinostat
干预措施: IV LBH589 (Drug)
Oral LBH589 + trastuzumab + paclitaxel
oral panobinostat
干预措施: Oral LBH589 (Drug)
Oral LBH589 + trastuzumab + paclitaxel
oral panobinostat
干预措施: trastuzumab (Drug)
Oral LBH589 + trastuzumab + paclitaxel
oral panobinostat
干预措施: paclitaxel (Drug)
结局指标
主要结局
Determine the maximum tolerated dose of oral panobinostat in combination with trastuzumab and paclitaxel. Determine the maximum tolerated dose of iv LBH in combination with trastuzumab and paclitaxel.
时间窗: At least 21 day cycle for both arms
次要结局
- Safety and tolerability throughout the study for both IV and oral arms to determine the recommended dose for phase ll trials.(4 weeks after end of treatment)
- To evaluate the efficacy in the expansion phase of the trial when the MTD is defined.(throughout the study and 4 weeks after end of treatment)