Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
146 participants
INTERVENTIONAL
2013-03-29
2016-09-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BKM120
BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28- day cycle
BKM120
BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28-day cycle
Interventions
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BKM120
BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28-day cycle
Eligibility Criteria
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Inclusion Criteria
* Patient's tumor was evaluated and pre-identified to have activation of the PI3K pathway, at a CLIA certified laboratory
* Patient must have received at least one prior treatment for recurrent metastatic and /or locally advanced disease and for whom no standard therapy options was anticipated to result in a durable remission.
* Patient must have had progressive and measurable disease as per RECIST 1.1. or other appropriate hematological guidelines
* Patient had an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
Exclusion Criteria
18 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Arizona Oncology Associates HOPE Division
Phoenix, Arizona, United States
Arizona Oncology Associates PC- HAL
Sedona, Arizona, United States
Highlands Oncology Group
Fayetteville, Arkansas, United States
Sarcoma Oncology Center
Santa Monica, California, United States
Rocky Mountain Cancer Centers RMCC - Aurora
Greenwood Village, Colorado, United States
Whittingham Cancer Center Norwalk Hospital
Norwalk, Connecticut, United States
Eastern Connecticut Hematology & Oncology Associates The Norwich Cancer Center
Norwich, Connecticut, United States
Florida Cancer Specialists Dept of Oncology (2)
Fort Myers, Florida, United States
Florida Hospital Cancer Institute FL Hosp. Cancer Instit.
Orlando, Florida, United States
Florida Cancer Specialists
West Palm Beach, Florida, United States
University Cancer & Blood Center, LLC
Athens, Georgia, United States
Southeastern Regional Medical Center
Newnan, Georgia, United States
Lurie Children's Hospital of Chicago Developmental Therapeutics
Chicago, Illinois, United States
Cancer Care Specialists of Central Illinois
Decatur, Illinois, United States
Illinois Cancer Care P.C. IL. Cancer Care
Peoria, Illinois, United States
Illinois Cancer Care P.C.
Peoria, Illinois, United States
Cancer Treatment Centers of America Southwestern Regional Med. Ctr
Schaumburg, Illinois, United States
Northern Indiana Cancer Research Consortium No. Indiana Cancer Res.
South Bend, Indiana, United States
University of Iowa Hospitals & Clinics Regulatory Contact 2
Iowa City, Iowa, United States
Eastern Maine Medical Center Research Center SC
Bangor, Maine, United States
Mount Auburn Hospital
Cambridge, Massachusetts, United States
Michigan Medicine University of Michigan Int. Medicine Oncology
Ann Arbor, Michigan, United States
Cancer and Hematology Centers of West Michigan Dept. of Oncology
Grand Rapids, Michigan, United States
Minnesota Oncology Hematology, P.A. Minnesota Oncology Hematology
Minneapolis, Minnesota, United States
Nebraska Cancer Specialists Oncology Hematology West
Omaha, Nebraska, United States
Comprehensive Cancer Centers
Las Vegas, Nevada, United States
Hematology Oncology Associates of Northern New Jersey PA Regional Cancer Care Assoc.
Morristown, New Jersey, United States
Cancer Center at Presbyterian
Albuquerque, New Mexico, United States
New York Oncology Hematology NY Onc Hem
Albany, New York, United States
Waverly Hematology Oncology
Cary, North Carolina, United States
University of N C at Chapel Hill Physician Office Building
Chapel Hill, North Carolina, United States
Duke University Medical Center Seeley G. Mudd Bldg.
Durham, North Carolina, United States
Cleveland Clinic Foundation Cleveland Clinic (19)
Cleveland, Ohio, United States
Mid Ohio Oncology/Hematology Mark H. Zangmeister Center
Columbus, Ohio, United States
Bend Memorial Clinic Bend Mem. Clinic
Bend, Oregon, United States
Northwest Cancer Specialists Compass Oncology (36)
Portland, Oregon, United States
Oregon Health and Science University Oregon Health & Science U (56)
Portland, Oregon, United States
Salem Health
Salem, Oregon, United States
Gettysburg Cancer Center
Gettysburg, Pennsylvania, United States
West Penn Allegheny Oncology Network
Natrona Heights, Pennsylvania, United States
University of Pittsburgh Medical Center UPMC
Pittsburgh, Pennsylvania, United States
Abington Hematology Oncology Associates, Inc Abington Hem Onc Assoc (5)
Willow Grove, Pennsylvania, United States
Sanford University of South Dakota Medical Center Sanford Health
Sioux Falls, South Dakota, United States
Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology
Chattanooga, Tennessee, United States
West Cancer Clinic
Memphis, Tennessee, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Texas Oncology P A Round Rock
Dallas, Texas, United States
Texas Oncology Sammons Cancer Center Sammons Cancer Center (10)
Dallas, Texas, United States
Texas Oncology, P.A. Texas Oncololgy, P.A. (8)
Fort Worth, Texas, United States
Oncology Consultants Oncology Group
Houston, Texas, United States
MD Anderson Cancer Center/University of Texas MD Anderson Cancer Center (3)
Houston, Texas, United States
Cancer Care Centers of South Texas HOAST CCC of So. TX-San Antonio (3)
San Antonio, Texas, United States
Tyler Cancer Center
Tyler, Texas, United States
Intermountain Medical Center Intermountain Healthcare
Murray, Utah, United States
Virginia Cancer Specialists Virginia Cancer Specialists
Fairfax, Virginia, United States
Blue Ridge Research Center at Roanoke Neurological Center McKesson Specialty Care
Roanoke, Virginia, United States
Kadlec Clinic Hematology and Oncology Kadlec Clinic Hematology & Onc
Kennewick, Washington, United States
Northwest Medical Specialties Hematology/Oncology
Tacoma, Washington, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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CBKM120ZUS40
Identifier Type: -
Identifier Source: org_study_id
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