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An Open Label Two-stage Study of Orally Administered BKM120 in Patients With Metastatic Non-small Cell Lung Cancer With Activated PI3K Pathway


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer

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Trial Information

An Open Label Two-stage Study of Orally Administered BKM120 in Patients With Metastatic Non-small Cell Lung Cancer With Activated PI3K Pathway


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS) as measured using RECIST 1.1

Outcome Time Frame:

Every 6 weeks

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CBKM120D2201

NCT ID:

NCT01297491

Start Date:

May 2011

Completion Date:

February 2015

Related Keywords:

  • Non-Small Cell Lung Cancer
  • NSCLC,
  • PI3K
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Northwest Cancer Specialists Vancouver LocationPortland, Oregon  97210
US Oncology Central MonitoringDallas, Texas  75246
Ironwood Cancer and Research Centers IronwoodChandler, Arizona  85224
Highlands Oncology Group Dept of Highlands Oncology GrpFayetteville, Arkansas  72703
Nevada Cancer Institute Dept. of Nevada Cancer (3)Las Vegas, Nevada  89135
Hematology Oncology Associates of Northern New Jersey PA DeptofHem-OncofNorthern NJ (2)Morristown, New Jersey  07962
Overlook Hospital - Carol G Simon Cancer Center Carol G SimonSummit, New Jersey  07901
Medical University of South Carolina MUSCCharleston, South Carolina  29425
Arizona Oncology Associates Tucson (Rudasill & La Cholla)Phoenix, Arizona  
Cedars Sinai Medical Center Dept.of Cedars-Sinai Med. Ctr.Los Angeles, California  90048
University of Kansas Cancer Center Univ of KSKansas City, Kansas  66160
Kansas City Cancer Center KCCC - SouthwestOverland Park, Kansas  66210
Virginia Oncology Associates VOA - Lake Wright (2)*see Various Departments*, Virginia  
Massachusetts General Hospital Mass GeneralBoston, Massachusetts  02114
Mayo Clinic - Arizona Mayo Scottsdale AZ*see Various Departments*, Arizona  
University of Colorado Univ COAurora, Colorado  80045
Rocky Mountain Cancer Centers Dept. of Rocky Mountain CancerGreenwood Village, Colorado  
H. Lee Moffitt Cancer Center/University of South Florida H Lee MoffittTampa, Florida  33612
Emory University School of Medicine/Winship Cancer Institute Emory 2Atlanta, Georgia  30322
University of Chicago Medical Center Unvi ChiChicago, Illinois  60546
Rush University Medical Center SCChicago, Illinois  60612
Indiana University Indiana Univ 2Indianapolis, Indiana  46202
Horizon Oncology Center Horizon OncLafayette, Indiana  47905
Fallon Clinic at Worcester Medical Center Fallon Clinic Worcester MedWorcester, Massachusetts  01608
Wayne State University/Karmanos Cancer Institute Wayne St KarmanosDetroit, Michigan  48201
Mayo Clinic - Rochester Mayo - Roch.Rochester, Minnesota  55905
Washington University School Of Medicine-Siteman Cancer Ctr Wash UniSt. Louis, Missouri  63110
University of Nebraska Medical Center CBKM120D2201Omaha, Nebraska  68198
The Center for Cancer and Hematologic Disease Dept. of the CCHDCherry Hill, New Jersey  08003
Roswell Park Cancer Institute RosewellBuffalo, New York  14263
Memorial Sloan Kettering Cancer Center Sloan KetteringNew York, New York  10021
Duke University Medical Center Duke 2Durham, North Carolina  27710
MetroHealth Medical Center Dept.ofMetroHealthMedCtr.(2)Cleveland, Ohio  44109-1998
University of Oklahoma Health Sciences Center Dept. of Oklahoma Univ. HSCOklahoma City, Oklahoma  73104
Vanderbilt University Medical Center, Clinical Trials Center Vanderbilt 2Nashville, Tennessee  37212
Texas Oncology, P.A. Austin LocationDallas, Texas  75251
U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research OfficeDallas, Texas  75390-9151
MD Anderson Cancer Center/University of Texas UT/MDHouston, Texas  77030-4009
Cancer Therapy & Research Center / UT Health Science Center CTRC 2San Antonio, Texas  78229
Oncology Hematology Associates of Southest Virginia Roanoke LocRoanoke, Virginia  24014
University of Wisconsin Univ WIsc 2Madison, Wisconsin  53792
Baylor College of Medicine Baylor Texas OncologyDallas, Texas  75246
University of California at San Diego, Moores Cancer Ctr SCSan Diego, California  92103
Georgia Regents University GHSUAugusta, Georgia  30912
University of Pittsburgh Medical Center SC-2Pittsburgh, Pennsylvania  
University of Virginia Health Systems SC-1Charlottesville, Virginia  22908-0334