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

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