Safety and Efficacy of BKM120 in Patients With Metastatic Non-small Cell Lung Cancer
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.
Checked against the public recordLast updated Mar 11, 2016 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Novartis Pharmaceuticals
- Interventions being studied
- Drug: BKM120
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Ironwood Cancer and Research Centers SCChandler, Arizona
- Arizona Oncology Associates Tucson (Rudasill & La Cholla)Phoenix, Arizona
- Mayo Clinic - Arizona Mayo Scottsdale AZScottsdale, Arizona
- Highlands Oncology Group Dept of Highlands Oncology GrpFayetteville, Arkansas
- Cedars Sinai Medical Center Dept.of Cedars-Sinai Med. Ctr.Los Angeles, California
- University of California at San Diego, Moores Cancer Ctr SCSan Diego, California
- University of Colorado Univ COAurora, Colorado
- Rocky Mountain Cancer Centers Dept. of Rocky Mountain CancerGreenwood Village, Colorado
- H. Lee Moffitt Cancer Center & Research Institute H Lee MoffittTampa, Florida
- Emory University School of Medicine/Winship Cancer Institute Emory 2Atlanta, Georgia
- Rush University Medical Center SCChicago, Illinois
- University of Chicago Medical Center Unvi ChiChicago, Illinois
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 11, 2016. Always confirm current availability with the study team.