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

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