Spots Global Cancer Trial Database for BNC105P in Combination With Everolimus/Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma
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Trial Identification
Brief Title: BNC105P in Combination With Everolimus/Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma
Official Title: 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
Study ID: NCT01034631
Conditions
Study Description
Brief Summary: The purpose of this study is to determine whether BNC105P in combination with/following everolimus is effective in the treatment of progressive metastatic clear cell renal cell carcinoma following prior tyrosine kinase inhibitors.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Northwest Alabama Cancer Center, Muscle Shoals, Alabama, United States
Genesis Cancer Center, Hot Springs, Arkansas, United States
Providence Health System: Roy and Patricia Disney Family Cancer Center, Burbank, California, United States
Compassionate Cancer Care Medical Group, Inc., Corona, California, United States
Compassionate Cancer Care Medical Group, Corona, California, United States
City of Hope, Duarte, California, United States
Robert A. Moss, M.D., FACP, Inc., Fountain Valley, California, United States
California Cancer Associates for Research and Excellence, Fresno, California, United States
Marin Specialty Care, Greenbrae, California, United States
Good Samaritan Hospital, Los Angeles, California, United States
UCLA Med - Hematology & Oncology, Los Angeles, California, United States
Compassionate Cancer Care Medical Group, Riverside, California, United States
American Institute of Research, Whittier, California, United States
Centura Health Research Center, Denver, Colorado, United States
Western Oncology & Hematology, Golden, Colorado, United States
Cancer Care Centers of Florida: Brooksville, Brooksville, Florida, United States
Broward Oncology Associates, Fort Lauderdale, Florida, United States
University of Florida, Shands Cancer Center, Gainesville, Florida, United States
Cancer Specialists of North Florida, Jacksonville, Florida, United States
Advanced Pharma CR, LLC, Miami, Florida, United States
Cancer Care Centers of Florida, New Port Richey, Florida, United States
Ocala Cancer Institute, Ocala, Florida, United States
Cancer Care Centers of Brevard, Rockledge, Florida, United States
Northeast Georgia Cancer Care, LLC, Athens, Georgia, United States
Dublin Hematology & Oncology Care, Dublin, Georgia, United States
Kootenai Cancer Center, Post Falls, Idaho, United States
Northwestern University, Robert H. Lurie Comprehensive Cancer Center, Chicago, Illinois, United States
Medical & Surgical Specialists, LLC, Galesburg, Illinois, United States
Edward H. Kaplan, M.D., & Associates, Skokie, Illinois, United States
Deaconess Clinic, Evansville, Indiana, United States
Fort Wayne Oncology & Hematology, Inc, Fort Wayne, Indiana, United States
IU Health Goshen, Goshen, Indiana, United States
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
IU Health Central Indiana Cancer Centers, Indianapolis, Indiana, United States
Community Regional Cancer Center, Indianapolis, Indiana, United States
Horizon Oncology Research, Lafayette, Indiana, United States
IU Health at Ball Memorial Hospital Cancer Center, Muncie, Indiana, United States
Monroe Medical Associates, Munster, Indiana, United States
Oncology Hematology Associates of SW Indiana, Newburgh, Indiana, United States
Northern Indiana Cancer Research Consortium, South Bend, Indiana, United States
Siouxland Hematology Oncology Associates, LLP, Nylen Cancer Center, Sioux City, Iowa, United States
Cancer Center of Kansas, Wichita, Kansas, United States
Kentucky Cancer Clinic, Hazard, Kentucky, United States
Purchase Cancer Group, Paducah, Kentucky, United States
Medical Oncology LLC, Baton Rouge, Louisiana, United States
Metairie Oncologists, Metairie, Louisiana, United States
Tufts Medical Center, Boston, Massachusetts, United States
St. Joseph Mercy Hospital, Ann Arbor, Michigan, United States
Cancer and Hematology Centers of Western Michigan, Grand Rapids, Michigan, United States
Metro Health Cancer Care, Wyoming, Michigan, United States
Mayo Clinic, Rochester, Minnesota, United States
Bozeman Deaconness Cancer Center, Bozeman, Montana, United States
Sletten Cancer Specialists, Great Falls, Montana, United States
Methodist Cancer Center, Omaha, Nebraska, United States
Dartmouth-Hitchcock Medical Center, Manchester, New Hampshire, United States
Trinitas Regional Medical Center, Elizabeth, New Jersey, United States
Somerset Hematology Oncology Associates, Somerville, New Jersey, United States
Presbyterian Medical Group, Albuquerque, New Mexico, United States
University of New Mexico Cancer Center: Albuquerque, Albuquerque, New Mexico, United States
New York Oncology Hematology, PC, Albany, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
NYU Langone Arena Oncology, Lake Success, New York, United States
Tisch Cancer Institute at Mount Sinai Medical Center, New York, New York, United States
Hematology Oncology Associates of Rockland, Nyack, New York, United States
First Health of the Carolinas, Pinehurst, North Carolina, United States
Signal Point Clinical Research Center, Middletown, Ohio, United States
Lawrence M. Stallings, M.D., Wooster, Ohio, United States
Mercy Physicians Of Oklahoma, Oklahoma City, Oklahoma, United States
Willamette Valley Cancer Institute, Springfield, Oregon, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Gettysburg Cancer Center, Gettysburg, Pennsylvania, United States
Allegheny Cancer Center, Pittsburgh, Pennsylvania, United States
Mount Nittany Medical Center, State College, Pennsylvania, United States
Berks Hematology Oncology Associates, West Reading, Pennsylvania, United States
Hematology and Oncology Associates of Rhode Island, Cranston, Rhode Island, United States
MUSC Hollings Cancer Center, Charleston, South Carolina, United States
South Carolina Cancer Specialists, Hilton Head Island, South Carolina, United States
The Jones Clinic, PC, Germantown, Tennessee, United States
Texas Oncology: Austin North, Austin, Texas, United States
Texas Oncology: Bedford, Bedford, Texas, United States
Texas Oncology, PA, Dallas, Texas, United States
Texas Oncology: Fort Worth, Fort Worth, Texas, United States
Texas Oncology: Houston Memorial City, Houston, Texas, United States
Methodist Hospital Research Institute, Houston, Texas, United States
Houston Cancer Center, Houston, Texas, United States
Joe Arrington Cancer Research and Treatment Center, Lubbock, Texas, United States
CTRC at The UT Health Science Center at San Antonio, San Antonio, Texas, United States
Lynchburg Hematology Oncology Clinic, Inc., Lynchburg, Virginia, United States
Harrison HealthPartners Bremerton Hematology & Oncology, Bremerton, Washington, United States
Cascade Cancer Center, Kirkland, Washington, United States
Group Health Medical Centers, Seattle, Washington, United States
University of Washington, Seattle Cancer Care Alliance, Seattle, Washington, United States
Rockwood Clinic, Spokane, Washington, United States
University of Wisconsin, Clinical Cancer Center, Milwaukee, Wisconsin, United States
Royal Prince Alfred Hospital: Sydney Cancer Centre, Camperdown, New South Wales, Australia
Prince of Wales Hospital, Randwick, New South Wales, Australia
Sydney Adventist Hospital Ltd., Wahroonga, New South Wales, Australia
Gallipoli Medical Research Foundation: Greenslopes Private Hospital, Greenslopes, Queensland, Australia
Royal Brisbane & Women's Hospital, Herston, Queensland, Australia
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Ashford Cancer Centre, Kurralta Park, South Australia, Australia
Gallipoli Medical Research Foundation: Launceston General Hospital, Launceston, Tasmania, Australia
Peninsula Oncology Centre, Frankston, Victoria, Australia
Austin Hospital, Heidelberg, Victoria, Australia
Alfred Hospital, Melbourne, Victoria, Australia
Royal Perth Hospital, Perth, Western Australia, Australia
National Cancer Centre Singapore, Singapore, , Singapore
Contact Details
Name: Thomas Hutson, D.O.
Affiliation: Hoosier Cancer Research Network
Role: STUDY_CHAIR
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