EUCTR2010-022015-19-BE进行中（未招募）1 期
A Phase II, single-arm study of orally administered BKM120 as second-line therapy in patients with advanced endometrial carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 161
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1.ECOG (Eastern Cooperative Oncology Group) performance status = 2
- •2. histologically confirmed diagnosis of advanced endometrial carcinoma
- •with available tissue specimen for identification of PI3K pathway
- •activation (archival tissue or a fixed fresh biopsy)
- •3. one prior line of antineoplastic treatment with a cytotoxic agent
- •4. objective progression of disease after prior treatment and at least one
- •measurable lesion as per RECIST criteria
- •5. adequate bone marrow and organ function
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. previous treatment with PI3K and/or mTOR inhibitors
- •2. symptomatic CNS metastases
- •3. concurrent malignancy or malignancy within 3 years of study
- •4. Active mood disorder as judged by investigator or medically
- •documented history of mood disorder (e.g. major depressive episode,
- •bipolar disorder, obsessive-compulsive disorder, schizophrenia, etc.), =
- •CTCAE grade 3 anxiety
- •5. pelvic and/or para-aortic radiotherapy = 28 days prior to enrollment
- •in the study
- •6.poorly controlled diabetes mellitus (HbA1c > 8 %)
- •7. history of cardiac dysfunction or active cardiac disease as specified in
- •the protocol
- •8. impairment of gastrointestinal (GI) function or GI disease that may
- •significantly alter the absorption of BKM120
研究者
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