BKM120 as Second-line Therapy for Advanced Endometrial Cancer

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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