EUCTR2011-002576-16-FR进行中（未招募）不适用
Phase 2 multicenter study to assess the safety and efficacy of BKM120 as monotherapy in the treatment of initial or recurrent metastatic endometrial cancer after first line therapy in patients who cannot undergo local surgery and/or radiotherapy. - ENDOPIK
ARCAGY0 个研究点开始时间: 2011年7月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Female = 18 years old.
- •ECOG performance index 0-2.
- •Patient with histological confirmed endometrial cancer.
- •Patient who is not eligible for exclusive curative treatment by surgery and/or radiotherapy.
- •Patient with initial metastatic endometrial cancer that has not been treated with chemotherapy or radiotherapy prior to inclusion
- •Patient with recurrent endometrial cancer previously treated with adjuvant chemotherapy and radiotherapy, presenting with a disease-free interval (period between the date of the last dose of chemotherapy and relapse) of at least 12 months.
- •Presence of one or more measurable lesion(s) outside the irradiated areas.
- •Availability at the time of inclusion of samples of tumor tissue, in the form of archived tissue (a block or at least 20 unstained slides) for tumor sub-classification (low grade = stratum 1; high grade = stratum 2) and for routine molecular analysis.
- •Satisfactory biological functions
- •Life expectancy 3 months.
- •The Information Consent Form (ICF) must be signed by the patient before any procedure is carried out.
- •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 56
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Previous treatment with PI3K inhibitors and/or mTOR.
- •Presence of symptomatic central nervous system (CNS) metastases.
- •Concomitant presence or history of another malignant tumor in the past 3 years prior to inclusion in the study (with the exception of spinocellular or cutaneous basal cell epithelioma or non-melanomatous skin cancer treated successfully).
- •Patient suffering from one of the following mood disorders based on an evaluation by the investigator or a psychiatrist OR with a limit score of = 10 on the PHQ-9 (Patient Health Questionnaire) OR a limit score of = 15 on the GAD-7 mood evaluation scale, respectively, OR with a positive response of 1, 2, or 3 to question number 9 relating to suicidal ideation in the PHQ-9 questionnaire (regardless of the overall score obtained in PHQ-9).
- •o Medically documented earlier or active major depressive episodes, bipolar disorders (I or II), compulsive obsessive disorders, schizophrenia, history of suicide attempts or suicidal ideation or homicidal ideation (immediate risk of harming another person).
- •o Anxiety = grade 3 CTCAE
- •Concomitant administration of another approved or investigational anticancer agent (hormonal agents included).
- •Pelvic and/or para-aortic radiotherapy within = 28 days prior to inclusion in the study or persistent side effects from this treatment on implementation of the selection procedures.
- •Major surgery during the 28 days prior to starting the investigational drug or persistent side effects from surgery.
- •Uncontrolled diabetes (HbA1c > 8 %).
- •Presence of an active heart disease
- •History of heart disease
- •Currently receiving treatment to prolong the QT interval accompanied by a known risk of triggering wave burst arrhythmia.
- •Gastrointestinal dysfunction (GI) or gastrointestinal disease (GD) that could significantly interfere with absorption of BKM120.
- •Chronic treatment with corticosteroids or other immunosuppressants.
- •Any other severe and/or uncontrolled concomitant disease
- •Currently receiving treatment known to be inhibitors or moderate and strong inducers of isoenzyme CYP3A.
- •Severe pneumonitis.
- •Grade = 3 biological anomalies.
- •Known history of HIV infection.
- •Pregnant woman or nursing mother
- •Woman of child-bearing potential must use highly effective contraception and must have a negative serum pregnancy test = 72 hours prior to initiating treatment.
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