BKM120 as Second-line Therapy for Advanced Endometrial Cancer



Status:Completed
Conditions:Cervical Cancer, Cancer, Cancer, Endometrial Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/30/2013
Start Date:February 2011
End Date:April 2013
Contact:Novartis Pharmaceuticals
Phone:+1(800)340-6843

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


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.


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
We found this trial at
22
sites
Bedford, Texas 76022
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Bedford, Texas 76022
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Bedford, TX
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Charlotte, NC
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Dallas, TX
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Dallas, Texas 75246
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Danville, Pennsylvania 17822
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Danville, PA
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Detroit, Michigan 48202
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Detroit, MI
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Duarte, CA
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Fayetteville, AR
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Morristown, New Jersey 07962
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Morristown, NJ
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Nashville, Tennessee 37203
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Nashville, TN
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Oklahoma City, OK
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Phoenix, AZ
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Portland, OR
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Portland, OR
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Raleigh, NC
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San Antonio, TX
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Seattle, Washington 98104
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Seattle, WA
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Silver Spring, Maryland 20910
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Silver Spring, MD
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Spokane, WA
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St. Louis, MO
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Tampa, FL
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