NCT01195376已完成1 期
A Phase I Study of BEZ235, Administered Orally in Adult Japanese Patients With Advanced Solid Tumors
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
- 35
- 试验地点
- 1
- 主要终点
- To establish Maximum tolerate dose (MTD)
研究概览
简要总结
In this study, BEZ235 will be administered to adult patients with advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will confirmed the safety and tolerability and determine the MTD of BEZ235 in Japanese patients.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically-confirmed, advanced unresectable solid tumors who have progressed on (or not been able to tolerate) standard therapy or for whom no standard anticancer therapy exists.
- •At least one measurable lesion as defined by RECIST criteria for solid tumors.
- •Eastern Cooperative Oncology Group Performance Status (ECOG P.S.) of ≤ 2
- •Life expectancy of ≥ 12 weeks
- •Patients must have the laboratory values Patients in the expansion part of this study have to meet the following criteria in addition to the criteria described above.
- •Availability of a representative tumor tissue specimen (either archival tumor or fresh tumor biopsy) for pre-screening.
- •Patients whose molecular status proved to meet the criteria (PIK3CA mutation/amplification and/or PTEN mutation and/or low/null PTEN expression) during pre-screening.
排除标准
- •Patients who have brain metastases or who have signs/symptoms attributable and have not been assessed with radiologic imaging to rule out the presence of brain metastases
- •Patients with any peripheral neuropathy ≥ CTCAE grade 2
- •Patients with unresolved diarrhea ≥ CTCAE grade 2
- •Patients with a history of photosensitivity reactions to other drugs
- •Women of child-bearing potential who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control. Barrier contraceptives must be used throughout the trial in both sexes. Women of child-bearing potential, defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least consecutive 1 years (i.e., who has had menses any time in the preceding consecutive 2 years), must have a negative serum pregnancy test ≤ 7 days prior to starting BEZ
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
BEZ235 Dose Escalation once daily
Experimental
oral BEZ235 once daily (q.d.)
干预措施: BEZ235 (Drug)
BEZ Dose escalation twice daily
Experimental
oral BEZ235 twice daily (b.i.d.)
干预措施: BEZ235 (Drug)
结局指标
主要结局
To establish Maximum tolerate dose (MTD)
时间窗: Every week
次要结局
- Safety assessed by type, frequency and severity of adverse events(Every week)
- Efficacy assessed by RECIST(Every 2 months)
- To characterize the PK profiles(Every 2 weeks)
- To assess the biomarkers(Every 2 months)
研究者
研究点 (1)
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