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

Status: Recruiting
Phase: Phase 2
Diagnosis: Lung Cancer
NCT ID: NCT01297491 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-231

 

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.

 

Conducting Institutions:
Massachusetts General Hospital, Brigham and Women's Hospital, Dana-Farber Cancer Institute

Overall PI:
Jeffrey Engelman, MD, PhD, Massachusetts General Hospital

Site-responsible Investigators:
Bruce Johnson, MD, Dana-Farber Cancer Institute

Contacts:
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute: Kelly Masone, 617-632-3383, kmasone@partners.org

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
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