BGJ398 for Patients With Tumors With FGFR Genetic Alterations
NCT ID: NCT02160041
Last Updated: 2019-06-18
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
84 participants
INTERVENTIONAL
2014-07-24
2018-04-30
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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BGJ398
BGJ398 was dosed on a flat scale of 125 mg (e.g., 1 x 100 mg and 1 x 25 mg capsules) once daily for the first 21 days of the 28-day cycle (3 weeks on, 1 week off in a cycle). A complete treatment cycle is defined as 28 days.
BGJ398
BGJ398 was dosed on a flat scale of 125 mg (e.g., 1 x 100 mg and 1 x 25 mg capsules) once daily for the first 21 days of the 28-day cycle (3 weeks on, 1 week off in a cycle). A complete treatment cycle is defined as 28 days.
Interventions
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BGJ398
BGJ398 was dosed on a flat scale of 125 mg (e.g., 1 x 100 mg and 1 x 25 mg capsules) once daily for the first 21 days of the 28-day cycle (3 weeks on, 1 week off in a cycle). A complete treatment cycle is defined as 28 days.
Eligibility Criteria
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Inclusion Criteria
Patient's tumor has been evaluated and pre-identified as having a tumor with a FGFR genetic alteration. The qualifying alteration must be assessed and reported by 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 are anticipated to result in a durable remission.
Patient must have progressive and measurable disease per RECIST 1.1. or other appropriate hematological response criteria.
Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
Exclusion Criteria
Patients with Central Nervous System (CNS) metastasis or leptomeningeal carcinomatosis
Patient has received chemotherapy or other anticancer therapy ≤ 4 weeks (6 weeks for nitrosourea, antibodies or mitomycin-C) prior to starting study drug.
Patients with acute or chronic pancreatitis
Patients with impaired cardiac function or clinically significant cardiac diseases
History and/or current evidence of extensive tissue calcification
Use of medications that increase serum levels of phosphorus and/or calcium
Current evidence of corneal or retinal disorder/keratopathy
History and/or current evidence of renal or endocrine alterations of calcium/phosphate homeostasis
Patients with another primary malignancy within 3 years prior to starting study treatment, with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or other non-melanomatous skin cancer, or in-situ carcinoma of the uterine cervix
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Alabama Oncology St. Vincent's Birmingham
Birmingham, Alabama, United States
North County Oncology Medical Clinic Inc
Oceanside, California, United States
San Francisco General Hospital San Francisco Gen Hosp (7)
San Francisco, California, United States
Rocky Mountain Cancer Centers Rocky Mountain Cancer Ctr (50)
Greenwood Village, Colorado, United States
Norwalk Hospital
Norwalk, Connecticut, United States
Florida Cancer Specialists Florida Cancer Specialists 36
Fort Myers, Florida, United States
University of Miami Sylvester Comprehensive Cancer
Miami, Florida, United States
NorthWest Georgia Oncology Centers NW Georgia Oncology
Marietta, Georgia, United States
Harbin Clinic Medical Oncology Clin. Res.
Rome, Georgia, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, United States
Lurie Children's Hospital of Chicago Developmental Therapeutics
Chicago, Illinois, United States
Community Clinical Research Center
Anderson, Indiana, United States
Indiana University Indiana Univ. - Purdue Univ.
Indianapolis, Indiana, United States
Northern Indiana Cancer Research Consortium No. Indiana Cancer Res.
South Bend, Indiana, United States
University of Louisville / James Graham Brown Cancer Center SC
Louisville, Kentucky, United States
St. Agnes Hospital St. Agnes Hospital (2)
Baltimore, Maryland, United States
Southcoast Centers for Cancer Care
Fairhaven, Massachusetts, United States
Cancer and Hematology Centers of West Michigan Dept. of Oncology
Grand Rapids, Michigan, United States
Minnesota Oncology Hematology, P.A. Minnesota Oncology Hem (27)
Minneapolis, Minnesota, United States
Research Medical Center Research Med Center (2)
Kansas City, Missouri, United States
Billings Clinic Billings Clinic (8)
Billings, Montana, United States
Dartmouth Hitchcock Medical Center Dartmouth Hitchcock - Lebanon
Bedford, New Hampshire, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
New Mexico Cancer Center
Albuquerque, New Mexico, 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
Wake Forest Baptist Health Hem & Onc Medical Center
Winston-Salem, North Carolina, United States
Sanford Hematology Oncology
Fargo, North Dakota, United States
Oncology Hematology Care Inc Oncology Hematology Care 2
Cincinnati, Ohio, United States
University Hospitals of Cleveland Seidman Cancer Center University Hospitals
Cleveland, Ohio, United States
Cleveland Clinic Foundation Taussig Cancer Institute
Cleveland, Ohio, United States
Bend Memorial Clinic Bend Mem. Clinic
Bend, Oregon, United States
Northwest Cancer Specialists Northwest Cancer
Portland, Oregon, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
Cancer Treatment Centers of America Eastern Regional Medical Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute Hillman Cancer Center (2)
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital Rhode Island Hosp. (2)
Providence, Rhode Island, 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
Tennessee Oncology Tennessee Oncology (3)
Nashville, Tennessee, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States
Oncology Consultants Oncology Group
Houston, Texas, United States
Houston Methodist Cancer Center
Houston, Texas, United States
MD Anderson Cancer Center/University of Texas MD Anderson Cancer Center (3)
Houston, Texas, United States
Texas Oncology
McAllen, Texas, United States
Cancer Therapy & Research Center UT Health Science Center Oncology Dept.
San Antonio, Texas, United States
Texas Oncology Cancer Care & Research Center Texas Oncology
Waco, Texas, United States
Deke Slayton Cancer Center Deke Slayton Cancer Center (2)
Webster, Texas, United States
Intermountain Medical Center Intermountain Healthcare
Murray, Utah, United States
Northern Utah Cancer Associates Northern Utah Assoc (3)
Ogden, Utah, United States
University of Utah / Huntsman Cancer Institute SC-2
Salt Lake City, Utah, United States
Utah Cancer Specialists Utah Cancer Specialists (11)
Salt Lake City, Utah, United States
Virginia Cancer Specialists Fairfax Northern Virginia
Fairfax, Virginia, United States
Shenandoah Oncology Shenandoah Oncology (5)
Winchester, Virginia, United States
Northwest Medical Specialties NW Medical Specialties
Tacoma, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CBGJ398XUS04
Identifier Type: -
Identifier Source: org_study_id
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