BKM120 as Second-line Therapy for Advanced Endometrial Cancer
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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.
Best Overall Response Rate (BORR) According to PI3K Activation Pathway Status [ Time Frame: 24 months ]
BOR was determined based on investigator assessment of overall lesion response using RECIST criteria guidelines.
BOR = objective responses rate (ORR), disease control rate (DCR) or clinical benefit rate (CBR). ORR = (complete response (CR) or partial response(PR); DCR = (CR or PR or Stable disease (SD); CBR = (CR or PR od SD >= 24 weeks)
Secondary Outcome Measures
Progression Free Survival (PFS) According to PI3K Activation Pathway Status [ Time Frame: 24 months ]
PFS is defined as the time from start of treatment to the date of first documented progression or death due to any cause. If a patient has not had an event, PFS will be censored at the date of last adequate tumor assessment.
Overall Survival (OS) According to PI3K Activation Pathway Status [ Time Frame: every 3 months ]
Overall survival (OS) was defined as the time from start of treatment to the date of death due to any cause. If a patient is not known to have died, survival was censored at the last date of contact. OS was to be reported at extension and after 3-year follow-up. The Kaplan-Meier median was used to analyze the OS.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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