GINECO-EN102b - BKM120 as Monotherapy in the Treatment of Initial or Recurrent Metastatic Endometrial Cancer

Inclusion Criteria: * Female ≥ 18 years * ECOG ≤ 2 * Histologically confirmed endometrial cancer * Not eligible for exclusive curative treatment by surgery and/or radiotherapy * Initial metastatic endometrial cancer not treated with chemotherapy or radiotherapy prior to inclusion OR * Recurrent endometrial cancer previously treated with adjuvant CT and RT, presenting with a disease-free interval of at least 12 months * Presence of one or more measurable lesion(s) outside the irradiated areas * Availability at inclusion of samples of tumor tissue (a block or at least 20 unstained slides) for tumor sub-classification and for routine molecular analysis * Satisfactory biological functions: PNN ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, hemoglobin ≥ 9.0 g/dL, INR ≤ 2, standard normal values for potassium, calcium and magnesium, serum creatinine ≤ 1.5 x ULN or creatinine clearance \> 50 mL/min, ALT and AST within normal range (or ≤ 3.0 x ULN if liver metastases present), Alkaline phosphatase ≤ 2.5 x ULN, serum bilirubin within normal range (or ≤ 1.5 x ULN if liver metastases present; or total bilirubin ≤ 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert Syndrome), fasting glycemia ≤ 120 mg/dL or ≤ 6.7 mmol/L * Life expectancy 3 months * Post menopausal woman with at least 12 months of natural (spontaneous) amenorrhea * Negative serum pregnancy test ≤ 72 hours prior to initiating treatment for woman of child-bearing potential * Consent form signed before any procedure performed Exclusion Criteria: * Previous treatment with PI3K inhibitors and/or mTOR * Presence of symptomatic CNS metastases. Patient must have completed any prior treatment for CNS metastases ≥ 28 days and, if on corticosteroid therapy, should be receiving a stable low dose * Concomitant presence or history of another malignant tumor in the past 3 years prior to inclusion (except spinocellular or cutaneous basal cell epithelioma or non-melanomatous skin cancer treated successfully) * Suffering from mood disorders based on an evaluation by the investigator or a psychiatrist OR with a given score according to the PHQ-9 or GAD-7 mood evaluation scale (cf protocol) * Concomitant administration of another approved or investigational anticancer agent * Pelvic and/or para-aortic radiotherapy within ≤ 28 days prior to inclusion or persistent side effects from this treatment on implementation of the selection procedures * Major surgery during the 28 days prior to starting investigational drug or persistent side effects from surgery * Uncontrolled diabetes (HbA1c \> 8 %) * Presence of an active heart disease, especially: LVEF \< 50 % determined by MUGA or ECHO, QTc \> 480 msec on ECG recorded during selection (with QTcF formula), angina warranting the administration of anti-angina treatment, ventricular arrhythmia except for benign premature ventricular contractions, supraventricular and nodal arrhythmias warranting a pacemaker or not controlled by a treatment, conduction anomalies warranting a pacemaker, valvular disease with documented involvement of cardiac function, symptomatic pericarditis * History of heart disease * Currently receiving treatment to prolong QT interval accompanied by a known risk of triggering wave burst arrhythmia. Impossible to stop treatment or to replace it before starting study medication * GI dysfunction or disease that could significantly interfere with absorption of BKM120 * Chronic treatment with corticosteroids or other immunosuppressants * Any other severe and/or uncontrolled concomitant disease, which is likely to contraindicate the patient's participation * Known treatment non-compliance * Currently receiving treatment known to be inhibitors or moderate and strong inducers of isoenzyme CYP3A. Impossible to stop this treatment or to replace it with a different treatment before starting the study product * Severe pneumonitis * Grade ≥ 3 biological anomalies * Known history of HIV infection * Pregnant woman or nursing mother