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
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 10
- 主要终点
- Best Overall Response Rate (BORR) According to PI3K Activation Pathway Status
研究概览
简要总结
This is a prospective multi-center, open-label, single arm, Phase II study to investigate the safety and efficacy of BKM120 in patients with advanced endometrial carcinoma whose disease progressed on or after a first-line antineoplastic treatment. Patients will receive BKM120 orally at a dose of 100 mg/day. Availability of tumor specimen (either archival tissue or a fixed fresh biopsy) is mandatory for assessment of the PI3K (Phosphatidylinositol 3 Kinase (PI3K) pathway activation status.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •ECOG (Eastern Cooperative Oncology Group) performance status ≤ 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)
- •one prior line of antineoplastic treatment with a cytotoxic agent
- •objective progression of disease after prior treatment and at least one measurable lesion as per RECIST criteria
- •adequate bone marrow and organ function
排除标准
- •previous treatment with PI3K and/or mTOR inhibitors
- •symptomatic CNS metastases
- •concurrent malignancy or malignancy within 3 years of study enrollment
- •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
- •pelvic and/or para-aortic radiotherapy ≤ 28 days prior to enrollment in the study
- •poorly controlled diabetes mellitus (HbA1c > 8 %)
- •history of cardiac dysfunction or active cardiac disease as specified in the protocol
- •impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BKM120
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
All Patients
干预措施: BKM120 (Drug)
结局指标
主要结局
Best Overall Response Rate (BORR) According to PI3K Activation Pathway Status
时间窗: 24 months
BOR was determined based on investigator assessment of overall lesion response using RECIST criteria guidelines. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
次要结局
- Progression Free Survival (PFS) According to PI3K Activation Pathway Status(24 months)
- Overall Survival (OS) According to PI3K Activation Pathway Status(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months)