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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Mar 11, 2016 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
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
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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/
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.