Safety and Efficacy of BKM120 in Patients With Metastatic Non-small Cell Lung Cancer



Status:Completed
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:May 2011
End Date:October 2014

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An Open Label Two-stage Study of Orally Administered BKM120 in Patients With Metastatic Non-small Cell Lung Cancer With Activated PI3K Pathway

The purpose of this two-stage phase II study is to assess the efficacy of BKM120, as
measured by determining the progression free survival (PFS), in patients with pretreated
metastatic Non-small Cell Lung Cancer (NSCLC) that exhibits PI3K pathway activation. BKM120
will be investigated in two groups of NSCLC patients according to the histology of the
cancer: squamous and non-squamous.


Inclusion Criteria:

- Histologically confirmed NSCLC with activated PI3K pathway

- Progressive disease after prior systemic antineoplastic treatment(s) for advanced
NSCLC

- Archival or fresh tumor biopsy must be available for profiling

- Measurable and/or non-measurable disease as per RECIST 1.1 criteria

- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

- Adequate organ function as assessed by laboratory tests

Exclusion Criteria:

- Patient has received previous treatment with PI3K inhibitors

- Patient with squamous NSCLC has received more than one line of chemotherapy treatment
for metastatic disease; patient with non-squamous NSCLC has received more than two
lines of systemic antineoplastic treatment for metastatic disease

- Uncontrolled or symptomatic CNS metastases

- Concurrent use of any other approved or investigational antineoplastic agent

- Radiotherapy ≤ 28 days prior to starting study drug

- Major surgery within 28 days prior to starting study drug

- History of clinically significant cardiac dysfunction, mood disorders, or poorly
controlled diabetes mellitus

- Current treatment with medication that has a known risk to prolong the QT interval or
inducing Torsades de Pointes

- Impairment of gastrointestinal (GI) function

- Chronic treatment with steroids or another immunosuppressive agent.

- Concurrent severe and/or uncontrolled medical condition

- Currently receiving Warfarin or another coumarin derivative

- Known history of HIV infection

- Sensory neuropathy with functional impairment (CTC grade 2 neuropathy, regardless of
causality)

- Pregnancy, lactation, or breastfeeding

- Woman of child-bearing potential

Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
33
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Fayetteville, AR
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*see Various Departments*, Virginia
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*see Various Departments*, VA
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Atlanta, GA
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Aurora, Colorado 80045
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Aurora, CO
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Boston, Massachusetts 02114
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Boston, MA
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Buffalo, New York 14263
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Buffalo, NY
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Chandler, Arizona 85224
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Chandler, AZ
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Charleston, South Carolina 29425
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Charleston, SC
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Chicago, IL
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Chicago, Illinois 60612
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Chicago, IL
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Cleveland, OH
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Detroit, MI
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Durham, North Carolina 27710
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Greenwood Village, CO
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Kansas City, KS
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Los Angeles, CA
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Madison, Wisconsin 53792
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Morristown, NJ
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NY, NY
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Oklahoma City, OK
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Portland, OR
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Rio Negro, Viedma
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Rio Negro,
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San Diego, CA
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Scottsdale, Arizona 85259
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Summit, NJ
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Worcester, MA
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