Safety and Efficacy of BKM120 in Patients With Metastatic Non-small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: BKM120
Intervention description: Buparlisib was supplied as 10mg or 50mg capsules. It was administered on a continuous once daily dosing schedule at a dose of 100 mg. The patient was dosed on a flat scale of mg/day and not adjusted to body weight or body surface area.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NSCLC; PI3K

Summary:

      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.
    

Eligibility criteria:

        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