NCT01285466已完成1 期
A Phase Ib Multi-center, Open-label, 4-arm Dose-escalation Study of Oral BEZ235 and BKM120 in Combination With Weekly Paclitaxel in Patients With Advanced Solid Tumors and Weekly Paclitaxel/Trastuzumab in Patients With HER2+ Metastatic Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Incidence of Dose limiting toxicities during the first cycle of treatment.
研究概览
简要总结
The purpose of the trial is to determine the maximum tolerated dose (MTD) of BEZ235 and BKM120 in combination with weekly paclitaxel and weekly paclitaxel/trastuzumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with metastatic or locally advanced solid tumors, for whom weekly paclitaxel treatment is indicated (BEZ235-paclitaxel /BKM120-paclitaxel treatment)
- •HER2+ metastatic or locally advanced breast cancer patients eligible for weekly paclitaxel and trastuzumab (BEZ235-paclitaxel-trastuzumab /BKM120-paclitaxel-trastuzumab treatment)
- •Adult patients (≥ 18 years) (males, females)
- •World Health Organization (WHO) performance status ≤ 2
- •Adequate bone marrow function:
- •Adequate hepatic and renal function:
排除标准
- •Patients with primary central nervous system (CNS) tumor or CNS tumor involvement. However, patients with a metastatic CNS lesion may participate in this trial, if the patient is > 4 weeks from therapy (including radiation and/or surgery) completion, clinically stable with respect to the tumor at the time of study entry, and not receiving enzyme-inducing antiepileptic drugs or corticosteroid therapy or taper, as treatment of the brain metastases
- •Patients who have received prior systemic anticancer therapy within the following time frames
- •Cyclical chemotherapy: ≤ 3 weeks before study treatment (6 weeks for patients treated with nitrosoureas)
- •Biological therapy: ≤ 4 weeks before study treatment, except treatment with trastuzumab (both parts of the trial)
- •Investigational drug: ≤ 4 weeks before study treatment
- •Patients who have undergone major surgery ≤ 4 weeks before study treatment
- •Patients receiving chronic treatment with corticosteroids or other immunosuppressive agents
- •Patients with uncontrolled, unmanageable, treatment-refractory diabetes mellitus
- •Active or history of major depressive episode, bipolar disorder, obsessive-compulsive disorder, schizophrenia, history of suicide attempt or ideation, or homicide, as judged by the investigator and/or based on recent psychiatric assessment
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
BEZ235 + paclitaxel
Experimental
干预措施: BEZ235 + paclitaxel (Drug)
BKM120 + paclitaxel
Experimental
干预措施: BKM120 + paclitaxel (Drug)
BEZ235 + paclitaxel + trastuzumab
Experimental
干预措施: BEZ235 + paclitaxel + trastuzumab (Drug)
BKM120 + paclitaxel + trastuzumab
Experimental
干预措施: BKM120 + paclitaxel + trastuzumab (Drug)
结局指标
主要结局
Incidence of Dose limiting toxicities during the first cycle of treatment.
时间窗: First treatment cycle (4 weeks)
次要结局
- Treatment efficacy (response to treatment according to RECIST criteria)(From start of treatment until disease progression)
- Incidence of safety events during the whole treatment period (until progression of disease).(From start of treatment until disease progression)
- pharmacokinetics of BEZ235, BKM120 and paclitaxel given in combination, on Day 1, 8 and 22.(First treatment cycle (4 weeks))
- Impact of treatment on biomarkers of Pi3 Kinase pathway (analyses of skin biopsies, circulating markers)(From start of treatment until disease progression)
研究者
研究点 (1)
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