BKM120 as Second-line Therapy for Advanced Endometrial Cancer

Phase 2

Completed

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
All Patients	BKM120	-

Primary Outcome Measures

Name	Time	Method
Best Overall Response Rate (BORR) According to PI3K Activation Pathway Status	24 months	BOR was determined based on investigator assessment of overall lesion response using RECIST criteria guidelines. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS) According to PI3K Activation Pathway Status	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. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Overall Survival (OS) According to PI3K Activation Pathway Status	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 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. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months

Locations (10): St. Joseph's Hospital & Medical Center St Joseph's
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Phoenix, Arizona, United States
University of Oklahoma Health Sciences Center OU Health
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Oklahoma City, Oklahoma, United States
Sarah Cannon Research Institute SCRI (2)
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Nashville, Tennessee, United States
South Texas Oncology and Hematology, PA South Tex Onc
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San Antonio, Texas, United States
Carolinas HealthCare Systems Blumenthal Cancer Center
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Charlotte, North Carolina, United States
Highlands Oncology Group Dept of Highlands Oncology Grp
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Fayetteville, Arkansas, United States
Morristown Memorial Hospital MMH
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Morristown, New Jersey, United States
Texas Oncology, P.A. Austin
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Bedford, Texas, United States
Cancer Care Northwest CC Northwest- Spokane South(3)
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Spokane, Washington, United States
Novartis Investigative Site
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Madrid, Spain