BKM120 as Second-line Therapy for Advanced Endometrial Cancer

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.

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Key information

Conditions

Advanced Endometrial Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Parkville, Victoria, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BKM120

Drug

Other names: Buparlisib

Primary outcomes

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. 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 outcomes

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. 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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Feb 3, 2011
Registry last updated: May 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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