BEZ235 Trial in Patients With Advanced Endometrial Carcinoma
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This is an open label and single arm study to investigate the safety and efficacy of BEZ235 in adult women with endometrial carcinoma whose disease progressed (or recurred) while on or after first-line antineoplastic treatment for advanced endometrial carcinoma.
assess the efficacy of BEZ235 as measured by Overall Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: every 8 weeks ]
Secondary Outcome Measures
evaluate additional efficacy parameters (e.g. Disease Control Rate, Progression-Free Survival) [ Time Frame: every 8 weeks ]
evaluate safety of BEZ235. Safety assessments will include vital signs, laboratory tests, and frequency of adverse events (non-serious and serious). [ Time Frame: Treatment start until 30 days after the last dose ]
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Female ≥ 18 years
Histological confirmed diagnosis of advanced endometrial carcinoma with available tissue specimen, either archival tissue or fresh formalin fixed tumor biopsy
Objective and radiologically confirmed progression of disease after prior first-line treatment
Recovery (to grade ≤ 1) from all clinically significant toxicities related to prior therapies (except alopecia) with adequate bone marrow and organ functions
At least one measurable lesion as per RECIST
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Previous treatment with PI3K and/or mammalian Target Of Rapamycin (mTOR) inhibitors
More than one line of prior treatment for advanced or metastatic disease
Active uncontrolled or symptomatic Central Nervous System (CNS) metastases
Concurrent malignancy or malignancy in the last 3 years prior to start of study treatment
Wide field radiotherapy ≤ 28 days or limited field radiation for palliation ≤ 14 days prior to enrollment in this study
Active cardiac disease (e.g. Left Ventricular Ejection Fraction (LVEF) < 50%, Q-T interval corrected for heart rate (QTcF) > 480 msec on screening Electrocardiogram (ECG), unstable angina pectoris, ventricular, supraventricular or nodal arrhythmias)
Inadequately controlled hypertension
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BEZ235
Drugs with a known risk to induce Torsades de Pointes, moderate and strong inhibitors or inducers of CYP3A4, warfarin and coumadin analogues, Luteinizing Hormone-Releasing Hormone (LHRH) agonists
Pregnant or nursing (lactating) woman
Other protocol-defined inclusion/exclusion criteria may apply