BEZ235 Trial in Patients With Advanced Endometrial Carcinoma

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II, Single-arm Study of Orally Administered BEZ235 as Second-line Therapy in Patients With Advanced or Metastatic Endometrial Carcinoma

Conditions
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Endometrial Cancer

Intervention / Treatment
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* Drug: BEZ235


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BEZ235<br> | Drug: BEZ235<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess the efficacy of BEZ235 as measured by Overall Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) |  | every 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate additional efficacy parameters (e.g. Disease Control Rate, Progression-Free Survival) |  | every 8 weeks | 
| evaluate safety of BEZ235. Safety assessments will include vital signs, laboratory tests, and frequency of adverse events (non-serious and serious). |  | Treatment start until 30 days after the last dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometrial cancer,, uterine cancer,, PI3K,, mTOR,, targeted therapy