NCT01856101终止2 期
A Single Arm, Multicenter, Phase II Study of BEZ235 as Monotherapy in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma (TCC) After Failure of Platinum Based Chemotherapy.
Cliniques universitaires Saint-Luc- Université Catholique de Louvain12 个研究点 分布在 2 个国家目标入组 22 人开始时间: 2013年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 22
- 试验地点
- 12
- 主要终点
- Determine the efficacy of BEZ235 in patients with palliative TCC
研究概览
简要总结
The mTOR (mammalian Target of Rapamycin) protein is the center of the mTOR pathway that plays an important role in cell growth, proliferation, survival and angiogenesis through sensing and integrating energetic signals from cellular environment. The mTOR protein is composed of two complex, mTOR complex 1 (mTOR C1) and mTOR complex 2 (mTOR C2).
In regards of mTOR pathway dysregulations observed in TCC development, there is a rational to test BEZ23 in advanced TCC. BEZ235 is a pan-class I PI3K inhibitor that, in addition, binds to the catalytic site of mTOR, inhibiting mTOR C1 and mTOR C2.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically- or cytologically-confirmed locally advanced or metastatic TCC not amenable to curative surgery or radiation.
- •Documented disease progression (according RECIST 1.1 criteria) after first line platinum-based therapy (given in neoadjuvant/adjuvant or palliative setting).
- •An interval of >4 weeks since last anticancer treatment.
- •Archival paraffin-embedded tumor tissue (block or at least 20 unstained slides) of the primary tumor and/or metastases. The most recent archival tissue is mandatory. Recidive of the disease should lead to perform if possible novel biopsies, as major oncogenic differences are found between primary tumor and secondary lesions.
- •At least one measurable lesion by MRI or CT-scan
- •ECOG performance status 0-1, in stable medical condition
- •Patients must have adequate organ function: Hemoglobin ≥ 9 g/100 ml, neutrophils ≥ 1,000/mm3, platelets ≥ 100,000/mm, INR ≤ 1.5, total serum bilirubin ≤ 1.5 x ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN (or <5.0 x ULN if hepatic metastases are present), creatinine £1.5 x ULN, fasting plasma glucose <140mg/dl, HbA1c < 8%.
- •Patients must be over 18 years old and able to give written informed consent.
- •Signed informed consent prior to beginning protocol specific procedure
排除标准
- •Non- TCC bladder cancer
- •More than 2 prior chemotherapy regimens given for palliation.
- •Concurrent malignancy or previous malignancy in the last 3 years prior to start the study treatment (with the exception of a history of adequately treated cervical carcinoma in situ or non-melanoma skin cancer)
- •Patient with active uncontrolled or symptomatic central nervous system (CNS metastases).
- •Significant active cardiac disease including uncontrolled high blood pressure, unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, or serious cardiac arrhythmias.
- •Other uncontrolled medical condition (active infections requiring antibiotics, bleeding disorders, uncontrolled diabetes ...)
- •Other concomitant anticancer therapy.
- •Previous therapy with PI3K and/or mTOR inhibitors (sirolimus, temsirolimus, everolimus)
- •Concomitant drugs such as coumarin and warfarin, and drugs known to induce torsade de pointe, drugs known to be moderate or strong inhibitors or inducers of CYP3A4
- •Pregnancy or risk of pregnancy.
研究组 & 干预措施
BEZ235, powder
Experimental
- Group 1: patients without PI3K pathway activation; no loss of PTEN and no activating PIK3CA mutation.
- Group 2: patients with PI3K pathway activation as defined by PIK3CA mutation and/or PTEN loss
干预措施: BEZ235 (Drug)
结局指标
主要结局
Determine the efficacy of BEZ235 in patients with palliative TCC
时间窗: at 16 weeks (radiological evaluation every 8 weeks)
o Control disease rate at 16 weeks, including complete responses, partial responses and stable diseases according to RECIST criteria.
次要结局
- Determine the safety profile of BEZ235 in patients with advanced TCC(participants will be followed for the duration of hospital stay, an expected average of 16 weeks)
研究者
研究点 (12)
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