- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT01034631
BNC105P in Combination With Everolimus/Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma
Phase I/II Study of BNC105P in Combination With Everolimus or Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma Following Prior Tyrosine Kinase Inhibitors
Przegląd badań
Szczegółowy opis
OUTLINE: This is a multi-center study.
Phase I: Patients will be accrued in the classic 3 patients per dose per cohort design, 21-day cycle
- Dose Level 1 Everolimus 10 mg BNC105P 4.2 mg/m2
- Dose Level 2 Everolimus 10 mg BNC105P 8.4 mg/m2
- Dose Level 3 Everolimus 10 mg BNC105P 12.6 mg/m2
- Dose Level 4 Everolimus 10 mg BNC105P 16 mg/m2
Phase II: Patients will be randomized 1:1 to Arm A or Arm B
Combination Arm A: Everolimus 10 mg + BNC105P MTD (from Phase 1 study) 21 day cycle
Sequential Arm B: Everolimus 10 mg 21 day cycle
- Patients to receive BNC105P monotherapy at 16 mg/m2 following progression or intolerable toxicity on everolimus therapy.
Karnofsky Performance Score (KPS) ≥70 within 7 days prior to registration for protocol therapy.
Life Expectancy: Not specified
Hematopoietic:
- White blood cell count (WBC) > 3.5 K/mm3
- Hemoglobin (Hgb) > 8.5 g/dL
- Platelets > 100 K/mm3
- Absolute neutrophil count (ANC) > 1.5 K/mm3
Hepatic:
- Total Bilirubin < 1.25 x ULN
- Aminotransferase (AST and ALT) < 2.5 x ULN
Renal:
- Serum Creatinine < 2.5 x ULN (upper limit normal)
Cardiovascular:
- No significant cardiovascular events within 6 months (CVA, CAD, peripheral arterial obstruction, arrhythmias, cardiac dysfunction) of registration for protocol therapy
- No history of clinical CHF or LVEF <50% by Echo (or MUGA) within 30 days prior to registration for protocol therapy.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 2
- Faza 1
Kontakty i lokalizacje
Lokalizacje studiów
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New South Wales
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Camperdown, New South Wales, Australia, 2050
- Royal Prince Alfred Hospital: Sydney Cancer Centre
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Randwick, New South Wales, Australia, 2031
- Prince of Wales Hospital
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Wahroonga, New South Wales, Australia, 2076
- Sydney Adventist Hospital Ltd.
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Queensland
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Greenslopes, Queensland, Australia, 4120
- Gallipoli Medical Research Foundation: Greenslopes Private Hospital
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Herston, Queensland, Australia, 4029
- Royal Brisbane & Women's Hospital
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Woolloongabba, Queensland, Australia, 4201
- Princess Alexandra Hospital
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South Australia
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Adelaide, South Australia, Australia, 5000
- Royal Adelaide Hospital
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Kurralta Park, South Australia, Australia, 5037
- Ashford Cancer Centre
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Tasmania
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Launceston, Tasmania, Australia, 7250
- Gallipoli Medical Research Foundation: Launceston General Hospital
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Victoria
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Frankston, Victoria, Australia, 3199
- Peninsula Oncology Centre
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Heidelberg, Victoria, Australia, 3084
- Austin Hospital
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Melbourne, Victoria, Australia, 3004
- Alfred Hospital
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Western Australia
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Perth, Western Australia, Australia, 6000
- Royal Perth Hospital
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Singapore, Singapur, 169610
- National Cancer Centre Singapore
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Alabama
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Muscle Shoals, Alabama, Stany Zjednoczone, 35661
- Northwest Alabama Cancer Center
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Arkansas
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Hot Springs, Arkansas, Stany Zjednoczone, 71913
- Genesis Cancer Center
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California
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Burbank, California, Stany Zjednoczone, 91505
- Providence Health System: Roy and Patricia Disney Family Cancer Center
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Corona, California, Stany Zjednoczone, 92879
- Compassionate Cancer Care Medical Group, Inc.
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Corona, California, Stany Zjednoczone, 92879
- Compassionate Cancer Care Medical Group
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Duarte, California, Stany Zjednoczone, 91010
- City of Hope
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Fountain Valley, California, Stany Zjednoczone, 92708
- Robert A. Moss, M.D., FACP, Inc.
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Fresno, California, Stany Zjednoczone, 93720
- California Cancer Associates for Research and Excellence
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Greenbrae, California, Stany Zjednoczone, 94904
- Marin Specialty Care
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Los Angeles, California, Stany Zjednoczone, 90017
- Good Samaritan Hospital
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Los Angeles, California, Stany Zjednoczone, 90095
- UCLA Med - Hematology & Oncology
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Riverside, California, Stany Zjednoczone, 92501
- Compassionate Cancer Care Medical Group
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Whittier, California, Stany Zjednoczone, 90603
- American Institute of Research
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Colorado
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Denver, Colorado, Stany Zjednoczone, 80210
- Centura Health Research Center
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Golden, Colorado, Stany Zjednoczone, 80401
- Western Oncology & Hematology
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Florida
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Brooksville, Florida, Stany Zjednoczone, 34613
- Cancer Care Centers of Florida: Brooksville
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Fort Lauderdale, Florida, Stany Zjednoczone, 33308
- Broward Oncology Associates
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Gainesville, Florida, Stany Zjednoczone, 32610
- University of Florida, Shands Cancer Center
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Jacksonville, Florida, Stany Zjednoczone, 32256
- Cancer Specialists of North Florida
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Miami, Florida, Stany Zjednoczone, 33136
- Advanced Pharma CR, LLC
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New Port Richey, Florida, Stany Zjednoczone, 34652
- Cancer Care Centers of Florida
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Ocala, Florida, Stany Zjednoczone, 34471
- Ocala Cancer Institute
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Rockledge, Florida, Stany Zjednoczone, 32955
- Cancer Care Centers of Brevard
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Georgia
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Athens, Georgia, Stany Zjednoczone, 30607
- Northeast Georgia Cancer Care, LLC
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Dublin, Georgia, Stany Zjednoczone, 31021
- Dublin Hematology & Oncology Care
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Idaho
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Post Falls, Idaho, Stany Zjednoczone, 83854
- Kootenai Cancer Center
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Illinois
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Chicago, Illinois, Stany Zjednoczone, 60611
- Northwestern University, Robert H. Lurie Comprehensive Cancer Center
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Galesburg, Illinois, Stany Zjednoczone, 61401
- Medical & Surgical Specialists, LLC
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Skokie, Illinois, Stany Zjednoczone, 60076
- Edward H. Kaplan, M.D., & Associates
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Indiana
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Evansville, Indiana, Stany Zjednoczone, 47713
- Deaconess Clinic
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Fort Wayne, Indiana, Stany Zjednoczone, 46815
- Fort Wayne Oncology & Hematology, Inc
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Goshen, Indiana, Stany Zjednoczone, 46527
- IU Health Goshen
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Indianapolis, Indiana, Stany Zjednoczone, 46202
- Indiana University Melvin and Bren Simon Cancer Center
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Indianapolis, Indiana, Stany Zjednoczone, 46219
- IU Health Central Indiana Cancer Centers
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Indianapolis, Indiana, Stany Zjednoczone, 46256
- Community Regional Cancer Center
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Lafayette, Indiana, Stany Zjednoczone, 47905
- Horizon Oncology Research
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Muncie, Indiana, Stany Zjednoczone, 47303
- IU Health at Ball Memorial Hospital Cancer Center
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Munster, Indiana, Stany Zjednoczone, 46321
- Monroe Medical Associates
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Newburgh, Indiana, Stany Zjednoczone, 47630
- Oncology Hematology Associates of SW Indiana
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South Bend, Indiana, Stany Zjednoczone, 46601
- Northern Indiana Cancer Research Consortium
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Iowa
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Sioux City, Iowa, Stany Zjednoczone, 51101
- Siouxland Hematology Oncology Associates, LLP, Nylen Cancer Center
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Kansas
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Wichita, Kansas, Stany Zjednoczone, 67214
- Cancer Center of Kansas
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Kentucky
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Hazard, Kentucky, Stany Zjednoczone, 41701
- Kentucky Cancer Clinic
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Paducah, Kentucky, Stany Zjednoczone, 42001
- Purchase Cancer Group
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Louisiana
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Baton Rouge, Louisiana, Stany Zjednoczone, 70809
- Medical Oncology LLC
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Metairie, Louisiana, Stany Zjednoczone, 70006
- Metairie Oncologists
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Massachusetts
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Boston, Massachusetts, Stany Zjednoczone, 02111
- Tufts Medical Center
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Michigan
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Ann Arbor, Michigan, Stany Zjednoczone, 48106
- St. Joseph Mercy Hospital
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Grand Rapids, Michigan, Stany Zjednoczone, 49546
- Cancer and Hematology Centers of Western Michigan
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Wyoming, Michigan, Stany Zjednoczone, 49519
- Metro Health Cancer Care
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Minnesota
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Rochester, Minnesota, Stany Zjednoczone, 55905
- Mayo Clinic
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Montana
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Bozeman, Montana, Stany Zjednoczone, 59715
- Bozeman Deaconness Cancer Center
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Great Falls, Montana, Stany Zjednoczone, 59405
- Sletten Cancer Specialists
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Nebraska
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Omaha, Nebraska, Stany Zjednoczone, 68114
- Methodist Cancer Center
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New Hampshire
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Manchester, New Hampshire, Stany Zjednoczone, 03102
- Dartmouth-Hitchcock Medical Center
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New Jersey
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Elizabeth, New Jersey, Stany Zjednoczone, 07202
- Trinitas Regional Medical Center
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Somerville, New Jersey, Stany Zjednoczone, 08876
- Somerset Hematology Oncology Associates
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New Mexico
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Albuquerque, New Mexico, Stany Zjednoczone, 87110
- Presbyterian Medical Group
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Albuquerque, New Mexico, Stany Zjednoczone, 87131
- University of New Mexico Cancer Center: Albuquerque
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New York
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Albany, New York, Stany Zjednoczone, 12208
- New York Oncology Hematology, PC
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Buffalo, New York, Stany Zjednoczone, 14263
- Roswell Park Cancer Institute
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Lake Success, New York, Stany Zjednoczone, 11042
- NYU Langone Arena Oncology
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New York, New York, Stany Zjednoczone, 10029
- Tisch Cancer Institute at Mount Sinai Medical Center
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Nyack, New York, Stany Zjednoczone, 10960
- Hematology Oncology Associates of Rockland
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North Carolina
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Pinehurst, North Carolina, Stany Zjednoczone, 28374
- First Health of the Carolinas
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Ohio
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Middletown, Ohio, Stany Zjednoczone, 45042
- Signal Point Clinical Research Center
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Wooster, Ohio, Stany Zjednoczone, 44691
- Lawrence M. Stallings, M.D.
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Oklahoma
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Oklahoma City, Oklahoma, Stany Zjednoczone, 73120
- Mercy Physicians Of Oklahoma
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Oregon
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Springfield, Oregon, Stany Zjednoczone, 97477
- Willamette Valley Cancer Institute
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Pennsylvania
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Danville, Pennsylvania, Stany Zjednoczone, 17822
- Geisinger Medical Center
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Gettysburg, Pennsylvania, Stany Zjednoczone, 17235
- Gettysburg Cancer Center
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Pittsburgh, Pennsylvania, Stany Zjednoczone, 15212
- Allegheny Cancer Center
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State College, Pennsylvania, Stany Zjednoczone, 16803
- Mount Nittany Medical Center
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West Reading, Pennsylvania, Stany Zjednoczone, 19611
- Berks Hematology Oncology Associates
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Rhode Island
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Cranston, Rhode Island, Stany Zjednoczone, 02920
- Hematology and Oncology Associates of Rhode Island
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South Carolina
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Charleston, South Carolina, Stany Zjednoczone, 29425
- MUSC Hollings Cancer Center
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Hilton Head Island, South Carolina, Stany Zjednoczone, 29926
- South Carolina Cancer Specialists
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Tennessee
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Germantown, Tennessee, Stany Zjednoczone, 38138
- The Jones Clinic, PC
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Texas
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Austin, Texas, Stany Zjednoczone, 78758
- Texas Oncology: Austin North
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Bedford, Texas, Stany Zjednoczone, 76022
- Texas Oncology: Bedford
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Dallas, Texas, Stany Zjednoczone, 75246
- Texas Oncology, PA
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Fort Worth, Texas, Stany Zjednoczone, 76104
- Texas Oncology: Fort Worth
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Houston, Texas, Stany Zjednoczone, 77030
- Methodist Hospital Research Institute
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Houston, Texas, Stany Zjednoczone, 77024
- Texas Oncology: Houston Memorial City
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Houston, Texas, Stany Zjednoczone, 77055
- Houston Cancer Center
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Lubbock, Texas, Stany Zjednoczone, 79410
- Joe Arrington Cancer Research and Treatment Center
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San Antonio, Texas, Stany Zjednoczone, 78229
- CTRC at the UT Health Science Center at San Antonio
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Virginia
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Lynchburg, Virginia, Stany Zjednoczone, 24501
- Lynchburg Hematology Oncology Clinic, Inc.
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Washington
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Bremerton, Washington, Stany Zjednoczone, 98310
- Harrison HealthPartners Bremerton Hematology & Oncology
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Kirkland, Washington, Stany Zjednoczone, 98034
- Cascade Cancer Center
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Seattle, Washington, Stany Zjednoczone, 98109
- University of Washington, Seattle Cancer Care Alliance
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Seattle, Washington, Stany Zjednoczone, 98109
- Group Health Medical Centers
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Spokane, Washington, Stany Zjednoczone, 99204
- Rockwood Clinic
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Wisconsin
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Milwaukee, Wisconsin, Stany Zjednoczone, 53226
- University of Wisconsin, Clinical Cancer Center
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Histological or cytological proof of component (any percent) of clear cell RCC (renal cell carcinoma).
- Metastatic or locally advanced unresectable RCC. NOTE: Prior nephrectomy is not mandatory.
- Progressive disease after 1-2 prior VEGF-directed tyrosine kinase inhibitors (TKIs).
- Measurable disease according to RECIST and obtained by imaging within 30 days prior to registration for protocol therapy.
- Written informed consent and HIPAA authorization for release of personal health information.
- Age > 18 years at the time of consent.
- Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 4 weeks after treatment discontinuation.
- Females of childbearing potential must have a negative pregnancy test within 7 days prior to registration for protocol therapy.
Exclusion Criteria:
- No active brain metastases. Patients with neurological symptoms must undergo a head CT scan or brain MRI to exclude brain metastasis within 30 days prior to registration on protocol therapy. NOTE: A patient with prior brain metastasis are eligible if they have completed their radiation treatment for brain metastasis ≥30 days prior to registration for protocol therapy, are off steroids, and are asymptomatic.
- No other currently active malignancy.
- No treatment with any investigational agent within 14 days prior to registration for protocol therapy. NOTE: If treated with investigational agent within 14 days prior to registration, AE must be resolved back to baseline.
- Prior cancer treatment must be completed at least 14 days prior to registration for protocol therapy and the patient must have recovered from the acute toxic effects of the regimen. With the exception of Bevacizumab treatment, which must be completed 30 days prior to registration for protocol therapy.
- Prior radiation therapy to < 25% of the bone marrow [see bone marrow radiation chart in the study procedure manual (SPM)] allowed if completed within 30 days prior to registration for protocol therapy.
- Corrected QT interval (QTc) ≤ 450 msec at least 7 days prior to registration for protocol therapy.
- No clinically significant infections as judged by the treating investigator.
- No liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis.
- No collecting duct, medullary or sarcomatoid histology.
- No prior treatment with temsirolimus or everolimus in the phase II component of the study. NOTE: Prior treatment with these agents is permitted in the phase I component of the study.
- No use of full dose, therapeutic anti-coagulation with warfarin or related anti-coagulants or unfractionated or low molecular weight heparins.
- No uncontrolled hypertension (BP >150/100mmHg despite full doses of 1 anti-hypertensive medication).
- No thrombotic event within 6 months (deep vein thrombosis, pulmonary embolism) of registration for protocol therapy.
- No grade 2 or greater peripheral neuropathy.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny komparator: Combination Arm A: Everolimus + BNC105P
Combination Arm A: Everolimus 10 mg, BNC105P MTD (from Phase 1 study) 21 day cycle
|
Everolimus 10 mg.
Taken orally, every evening, 1 hr before or 2 hrs after meals
BNC105P, up to 16 mg/m^2
|
|
Aktywny komparator: Sequential Arm B:Everolimus followed by BNC105P Monotherapy
Sequential Arm B: Everolimus 10 mg, 21 day cycle Patients to receive BNC105P monotherapy at 16 mg/m2 following progression or intolerable toxicity on everolimus therapy. |
Everolimus 10 mg.
Taken orally, every evening, 1 hr before or 2 hrs after meals
BNC105P, up to 16 mg/m^2
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Phase I: Maximum Tolerated Dose of BNC105P in Combination With Everolimus.
Ramy czasowe: Until disease progression or unacceptable toxicity, up to 24 cycles or 24 months
|
Phase I
|
Until disease progression or unacceptable toxicity, up to 24 cycles or 24 months
|
|
Phase I: Toxicities of BNC105P in Combination With Everolimus.
Ramy czasowe: Until disease progression or unacceptable toxicity, up to 24 cycles or 24 months
|
Determine the toxicities of BNC105P in combination with everolimus.
Drug-related treatment emergent adverse events by CTCAE grade 2 or greater are reported
|
Until disease progression or unacceptable toxicity, up to 24 cycles or 24 months
|
|
Phase II: 6-month Progression Free Survival (PFS) With the Addition of BNC105P to Everolimus.
Ramy czasowe: 6 months
|
Improvement in 6-month PFS with the addition of BNC105P to everolimus.
Progression is defined using RECIST criteria as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
|
6 months
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Phase I: Response Rate of BNC105P in Combination With Everolimus.
Ramy czasowe: Until disease progression or unacceptable toxicity, up to 24 cycles or 24 months
|
Number of objective responses per RECIST criteria.
Complete Response (CR): Disappearance of all target lesions.
Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
|
Until disease progression or unacceptable toxicity, up to 24 cycles or 24 months
|
|
Geometric Mean Half-life of BNC105 and BNC105P in Combination With Everolimus.
Ramy czasowe: 12 months
|
Determine the PK Profile for BN105P in combination with everolimus by calculating the geometric mean half-life of BNC105P
|
12 months
|
|
Phase II: Response Rate With Combination Therapy Compared to Everolimus Alone
Ramy czasowe: 12 months
|
Objective response is defined as a confirmed CR or PR per RECIST criteria.
Complete Response (CR): Disappearance of all target lesions.
Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
|
12 months
|
|
Phase II: Progression Free Survival (PFS) With BNC105P Alone in Patients After Progressing on Everolimus.
Ramy czasowe: 12 months
|
Median time to progression for arm P participants who crossed over to BNC105P monotherapy after progression.
Progression is defined per RECIST criteria as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
|
12 months
|
|
Phase II: Adverse Events of Everolimus and BNC105P When Administered as a Combination or Sequential Regimen.
Ramy czasowe: 12 months
|
Determine adverse events of everolimus and BNC105P when administered as a combination or sequential regimen.
Total number of serious and non-serious adverse events for Arm A and Arm B are summarized.
Complete adverse event information is supplied in the Adverse Events reporting section.
|
12 months
|
|
Phase II: Overall Survival
Ramy czasowe: 60 months
|
Determine overall survival probability, up to a maximum of 5 years from registration for protocol therapy.
|
60 months
|
|
Exploratory Objective: Correlation of PFS With Biomarkers
Ramy czasowe: 6 months
|
Exploratory analysis of serum biomarkers were undertaken to generate a potential signature for response.
The correlation with 6 month progression free survival P value for four plasma biomarkers is reported.
|
6 months
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Krzesło do nauki: Thomas Hutson, D.O., Hoosier Cancer Research Network
Publikacje i pomocne linki
Publikacje ogólne
- Thomas E. Hutson, Long H. Dang, Richard C. Lauer, Alexander Starodub, Ralph J. Hauke, Matt D. Galsky, Kathryn A. Bylow, Theodore Logan, Charles Lance Cowey, David C. Bibby, Gabriel Kremmidiotis, Elizabeth E. Doolin, Tina C. Lavranos, Guru Sonpavde, Noah M. Hahn, Christopher Sweeney, John Sarantopoulos. Phase I results of a phase I/II trial of BNC105P with everolimus in metastatic renal cell carcinoma (mRCC) patients previously treated with VEGFR tyrosine kinase inhibitors. J Clin Oncol 30, 2012 (suppl; abstr 4603) http://www.asco.org/ASCOv2/Meetings/Abstracts&vmview=abst_detail_view&confID=114&abstractID=91911
- John Sarantopoulos, Long H. Dang, Richard C. Lauer, Alexander Starodub, Ralph J. Hauke, Matt D. Galsky, Kathryn A. Bylow, Charles Lance Cowey, David C. Bibby, Gabriel Kremmidiotis, Elizabeth E. Doolin, Tina C. Lavranos, Jose Luis Iglesias, Guru Sonpavde, Theodore Logan, Noah M. Hahn, Christopher Sweeney, Thomas E. Hutson. A phase I/II trial of BNC105P with everolimus in metastatic renal cell carcinoma (mRCC) patients: Updated phase I results of the Disruptor-1 trial. J Clin Oncol 31, 2013 (suppl; abstr 4563. http://abstracts2.asco.org/AbstView_132_107981.html
- Pal S, Azad A, Bhatia S, Drabkin H, Costello B, Sarantopoulos J, Kanesvaran R, Lauer R, Starodub A, Hauke R, Sweeney CJ, Hahn NM, Sonpavde G, Richey S, Breen T, Kremmidiotis G, Leske A, Doolin E, Bibby DC, Simpson J, Iglesias J, Hutson T. A Phase I/II Trial of BNC105P with Everolimus in Metastatic Renal Cell Carcinoma. Clin Cancer Res. 2015 Aug 1;21(15):3420-7. doi: 10.1158/1078-0432.CCR-14-3370. Epub 2015 Mar 18.
- Yang ES, Nassar AH, Adib E, Jegede OA, Alaiwi SA, Manna DLD, Braun DA, Zarei M, Du H, Pal SK, Naik G, Sonpavde GP. Gene Expression Signature Correlates with Outcomes in Metastatic Renal Cell Carcinoma Patients Treated with Everolimus Alone or with a Vascular Disrupting Agent. Mol Cancer Ther. 2021 Aug;20(8):1454-1461. doi: 10.1158/1535-7163.MCT-20-1091. Epub 2021 Jun 9.
Przydatne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Nowotwory według typu histologicznego
- Nowotwory
- Nowotwory urologiczne
- Nowotwory układu moczowo-płciowego
- Nowotwory według lokalizacji
- Choroby nerek
- Choroby Urologiczne
- Rak gruczołowy
- Nowotwory gruczołowe i nabłonkowe
- Nowotwory nerek
- Rak, Komórka Nerki
- Rak
- Fizjologiczne skutki leków
- Środki przeciwnowotworowe
- Środki immunosupresyjne
- Czynniki immunologiczne
- Ewerolimus
Inne numery identyfikacyjne badania
- HOG GU09-145
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Rak nerkowokomórkowy
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Daryoush Hamidi Alamdari, PhDRejestracja na zaproszenieChoroba nieoperacyjna | Zaawansowany rak podstawnokomórkowy (BCC) | Morpheaform Basal Cell Carcinoma | Rak podstawnokomórkowy guzkowo-wrzodziejący | Infiltratywny rak podstawnokomórkowyIran
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Fady M Kaldas, M.D., F.A.C.S.ZakończonyOceny immunosupresji modulacji na Renal Recovery Post LTStany Zjednoczone
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Taichung Veterans General HospitalZakończonyKardiotoksyczność | Rak płuca niedrobnokomórkowy (MeSH Term: Carcinoma, Non-Small-Cell Lung) | Działania niepożądane i reakcje niepożądane związane z lekami (Termin MeSH) | Inhibitor kinazy tyrozynowej EGFRTajwan
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Fondazione del Piemonte per l'OncologiaRekrutacyjnyRak piersi | Rak jajnika | Rak jelita grubego | Czerniak (rak skóry) | Rak płuca niedrobnokomórkowy (MeSH Term: Carcinoma, Non-Small-Cell Lung)Włochy
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LIANG WANGJeszcze nie rekrutacja
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Shanghai General Hospital, Shanghai Jiao Tong University...Jeszcze nie rekrutacja
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Tarapeutics Science Inc.Jeszcze nie rekrutacjaPTCL | Chłoniak T-komórkowy NKChiny
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)ZakończonyPrzewlekła białaczka limfocytowa | Nawracający chłoniak z małych limfocytów | Białaczka prolimfocytowa | Oporna na leczenie przewlekła białaczka limfocytowa | Nawracająca przewlekła białaczka limfocytowa | Białaczka prolimfocytowa T-komórkowa | Białaczka prolimfocytowa B-komórkowaStany Zjednoczone, Włochy
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Shanghai General Hospital, Shanghai Jiao Tong University...Jeszcze nie rekrutacja
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Beijing Tongren HospitalJeszcze nie rekrutacjaPozawęzłowy chłoniak z komórek NK/TChiny
Badania kliniczne na Everolimus
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German Breast GroupNovartisZakończonyRak piersi z przerzutamiNiemcy
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Novartis PharmaceuticalsZakończonyGuz neuroendokrynny żołądka i jelit trzustki układu płucnego lub żołądkowo-jelitowo-trzustkowegoNiemcy
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Fudan UniversityJeszcze nie rekrutacjaPotrójnie ujemny rak piersi (TNBC) | Kobiety z rakiem piersi
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Cardiovascular and Interventional Radiological...AbbottJeszcze nie rekrutacjaPrzewlekłe niedokrwienie kończyny zagrażające | Przewlekłe niedokrwienie zagrażające kończynom
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University of Wisconsin, MadisonNational Institute on Aging (NIA)Aktywny, nie rekrutujący
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Xuanwu Hospital, BeijingRekrutacyjnyPadaczka | Odporny na lekiChiny
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University of California, San FranciscoNovartis Pharmaceuticals; Pacific Pediatric Neuro-Oncology Consortium; The Pediatric...ZakończonyPediatryczne nawracające postępujące glejaki o niskim stopniu złośliwości | Pediatryczne postępujące glejaki o niskim stopniu złośliwościStany Zjednoczone
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Boston Children's HospitalRejestracja na zaproszenie
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Yonsei UniversityZakończonyPadaczka i ogniskowa dysplazja korowa IIRepublika Korei
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AIO-Studien-gGmbHNovartis Pharmaceuticals; Assign Data Management and Biostatistics GmbHZakończonyRak neuroendokrynny, stopień 3 | Słabo zróżnicowany złośliwy rak neuroendokrynny | Rak neuroendokrynny, stopień 1 [dobrze zróżnicowany rak neuroendokrynny], który przeszedł do G3 | Rak neuroendokrynny stopnia 2 [średnio zróżnicowany rak neuroendokrynny], który przeszedł do G3 | Guz neuroendokrynny...Niemcy