BKM120 as Second-line Therapy for Advanced Endometrial Cancer

Inclusion Criteria:

- ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2

- histologically confirmed diagnosis of advanced endometrial carcinoma with available
tissue specimen for identification of PI3K pathway activation (archival tissue or a
fixed fresh biopsy)

- one prior line of antineoplastic treatment with a cytotoxic agent

- objective progression of disease after prior treatment and at least one measurable
lesion as per RECIST criteria

- adequate bone marrow and organ function

Exclusion Criteria:

- previous treatment with PI3K and/or mTOR inhibitors

- symptomatic CNS metastases

- concurrent malignancy or malignancy within 3 years of study enrollment

- Active mood disorder as judged by investigator or medically documented history of
mood disorder (e.g. major depressive episode, bipolar disorder, obsessive-compulsive
disorder, schizophrenia, etc.), ≥ CTCAE grade 3 anxiety

- pelvic and/or para-aortic radiotherapy ≤ 28 days prior to enrollment in the study

- poorly controlled diabetes mellitus (HbA1c > 8 %)

- history of cardiac dysfunction or active cardiac disease as specified in the protocol

- impairment of gastrointestinal (GI) function or GI disease that may significantly
alter the absorption of BKM120

Other protocol-defined inclusion/exclusion criteria may apply