NCT01290406撤回2 期
A Phase II, Single-arm Study of Orally Administered BEZ235 as Second-line Therapy in Patients With Advanced or Metastatic Endometrial Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 17
- 主要终点
- assess the efficacy of BEZ235 as measured by Overall Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST)
研究概览
简要总结
This is an open label and single arm study to investigate the safety and efficacy of BEZ235 in adult women with endometrial carcinoma whose disease progressed (or recurred) while on or after first-line antineoplastic treatment for advanced endometrial carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Female ≥ 18 years
- •Histological confirmed diagnosis of advanced endometrial carcinoma with available tissue specimen, either archival tissue or fresh formalin fixed tumor biopsy
- •Objective and radiologically confirmed progression of disease after prior first-line treatment
- •Recovery (to grade ≤ 1) from all clinically significant toxicities related to prior therapies (except alopecia) with adequate bone marrow and organ functions
- •At least one measurable lesion as per RECIST
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
排除标准
- •Previous treatment with PI3K and/or mammalian Target Of Rapamycin (mTOR) inhibitors
- •More than one line of prior treatment for advanced or metastatic disease
- •Active uncontrolled or symptomatic Central Nervous System (CNS) metastases
- •Concurrent malignancy or malignancy in the last 3 years prior to start of study treatment
- •Wide field radiotherapy ≤ 28 days or limited field radiation for palliation ≤ 14 days prior to enrollment in this study
- •Active cardiac disease (e.g. Left Ventricular Ejection Fraction (LVEF) < 50%, Q-T interval corrected for heart rate (QTcF) > 480 msec on screening Electrocardiogram (ECG), unstable angina pectoris, ventricular, supraventricular or nodal arrhythmias)
- •Inadequately controlled hypertension
- •Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BEZ235
- •Drugs with a known risk to induce Torsades de Pointes, moderate and strong inhibitors or inducers of CYP3A4, warfarin and coumadin analogues, Luteinizing Hormone-Releasing Hormone (LHRH) agonists
- •Pregnant or nursing (lactating) woman
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
BEZ235
Experimental
干预措施: BEZ235 (Drug)
结局指标
主要结局
assess the efficacy of BEZ235 as measured by Overall Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST)
时间窗: every 8 weeks
次要结局
- evaluate additional efficacy parameters (e.g. Disease Control Rate, Progression-Free Survival)(every 8 weeks)
- evaluate safety of BEZ235. Safety assessments will include vital signs, laboratory tests, and frequency of adverse events (non-serious and serious).(Treatment start until 30 days after the last dose)
研究者
研究点 (17)
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