BKM120 as Second-line Therapy for Advanced Endometrial Cancer

A Phase II, Single-arm Study of Orally Administered BKM120 as Second-line Therapy in Patients With Advanced Endometrial Carcinoma

This is a prospective multi-center, open-label, single arm, Phase II study to investigate the safety and efficacy of BKM120 in patients with advanced endometrial carcinoma whose disease progressed on or after a first-line antineoplastic treatment. Patients will receive BKM120 orally at a dose of 100 mg/day. Availability of tumor specimen (either archival tissue or a fixed fresh biopsy) is mandatory for assessment of the PI3K (Phosphatidylinositol 3 Kinase (PI3K) pathway activation status.

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