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

Completed · Phase 2

Conditions studied: Non-small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT01297491

Run by

Novartis Pharmaceuticals

People needed

63

Starts

2011-05-01

Expected to finish

2014-10-01

Last updated by the study team

2016-03-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arizona Oncology Associates Tucson (Rudasill & La Cholla) — Phoenix, Arizona, United States
• Mayo Clinic - Arizona Mayo Scottsdale AZ — Scottsdale, Arizona, United States
• Highlands Oncology Group Dept of Highlands Oncology Grp — Fayetteville, Arkansas, United States
• Cedars Sinai Medical Center Dept.of Cedars-Sinai Med. Ctr. — Los Angeles, California, United States
• University of California at San Diego, Moores Cancer Ctr SC — San Diego, California, United States
• University of Colorado Univ CO — Aurora, Colorado, United States
• Rocky Mountain Cancer Centers Dept. of Rocky Mountain Cancer — Greenwood Village, Colorado, United States
• H. Lee Moffitt Cancer Center & Research Institute H Lee Moffitt — Tampa, Florida, United States
• Emory University School of Medicine/Winship Cancer Institute Emory 2 — Atlanta, Georgia, United States
• Rush University Medical Center SC — Chicago, Illinois, United States
• University of Chicago Medical Center Unvi Chi — Chicago, Illinois, United States
• University of Kansas Cancer Center Univ of KS — Kansas City, Kansas, United States
• Massachusetts General Hospital Mass General — Boston, Massachusetts, United States
• Fallon Clinic at Worcester Medical Center Fallon Clinic Worcester Med — Worcester, Massachusetts, United States
• Karmanos Cancer Institute Wayne St Karmanos — Detroit, Michigan, United States
• Washington University School of Medicine Washington University (16) — St Louis, Missouri, United States
• Hematology Oncology Associates of Northern New Jersey PA DeptofHem-OncofNorthern NJ (2) — Morristown, New Jersey, United States
• Overlook Hospital - Carol G Simon Cancer Center Carol G Simon — Summit, New Jersey, United States
• Roswell Park Cancer Institute Rosewell — Buffalo, New York, United States
• Memorial Sloan Kettering Cancer Center Sloan Kettering — New York, New York, United States
• Duke University Medical Center Duke 2 — Durham, North Carolina, United States
• MetroHealth Medical Center Dept.ofMetroHealthMedCtr.(2) — Cleveland, Ohio, United States
• University of Oklahoma Health Sciences Center Dept. of Oklahoma Univ. HSC — Oklahoma City, Oklahoma, United States
• Northwest Cancer Specialists Compass Oncology -BKM — Portland, Oregon, United States
• Ironwood Cancer and Research Centers SC — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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