BKM120 as Second-line Therapy for Advanced Endometrial Cancer
NCT ID: NCT01289041
Last Updated: 2019-05-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
70 participants
INTERVENTIONAL
2011-02-28
2014-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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All Patients
BKM120
Interventions
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BKM120
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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St. Joseph's Hospital & Medical Center St Joseph's
Phoenix, Arizona, United States
Highlands Oncology Group Dept of Highlands Oncology Grp
Fayetteville, Arkansas, United States
Morristown Memorial Hospital MMH
Morristown, New Jersey, United States
Carolinas HealthCare Systems Blumenthal Cancer Center
Charlotte, North Carolina, United States
University of Oklahoma Health Sciences Center OU Health
Oklahoma City, Oklahoma, United States
Sarah Cannon Research Institute SCRI (2)
Nashville, Tennessee, United States
Texas Oncology, P.A. Austin
Bedford, Texas, United States
South Texas Oncology and Hematology, PA South Tex Onc
San Antonio, Texas, United States
Cancer Care Northwest CC Northwest- Spokane South(3)
Spokane, Washington, United States
Novartis Investigative Site
Parkville, Victoria, Australia
Novartis Investigative Site
Leuven, , Belgium
Novartis Investigative Site
Liège, , Belgium
Novartis Investigative Site
Wilrijk, , Belgium
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Rio de Janeiro, Rio de Janeiro, Brazil
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Vancouver, British Columbia, Canada
Novartis Investigative Site
Hamilton, Ontario, Canada
Novartis Investigative Site
Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Le Mans, , France
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Lyon, , France
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Nice, , France
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Toulouse, , France
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Berlin, , Germany
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Berlin, , Germany
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Cologne, , Germany
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Mainz, , Germany
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Milan, MI, Italy
Novartis Investigative Site
Aviano, PN, Italy
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Bologna, , Italy
Novartis Investigative Site
Napoli, , Italy
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Chuo-ku, Tokyo, Japan
Novartis Investigative Site
Minato-ku, Tokyo, Japan
Novartis Investigative Site
Warsaw, , Poland
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Saint Petersburg, , Russia
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Singapore, , Singapore
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Valencia, Valencia, Spain
Novartis Investigative Site
Valencia, Valencia, Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Madrid, , Spain
Countries
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Other Identifiers
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2010-022015-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CBKM120C2201
Identifier Type: -
Identifier Source: org_study_id
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