BNC105P in Combination With Everolimus/Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma
This trial is active, not recruiting.
|Condition||renal cell carcinoma|
|Sponsor||Hoosier Cancer Research Network|
|Start date||January 2010|
|End date||November 2016|
|Trial size||152 participants|
|Trial identifier||NCT01034631, HOG GU09-145|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Birmingham, AL||University of Alabama at Birmingham Cancer Center||no longer recruiting|
|Muscle Shoals, AL||Northwest Alabama Cancer Center||no longer recruiting|
|Hot Springs, AR||Genesis Cancer Center||no longer recruiting|
|Burbank, CA||Providence Health System: Roy and Patricia Disney Family Cancer Center||no longer recruiting|
|Corona, CA||Compassionate Cancer Care Medical Group||no longer recruiting|
|Duarte, CA||City of Hope Comprehensive Cancer Center||completed|
|Fountain Valley, CA||Robert A. Moss, M.D., FACP, Inc.||no longer recruiting|
|Fresno, CA||California Cancer Associates for Research and Excellence||no longer recruiting|
|Greenbrae, CA||Marin Specialty Care||no longer recruiting|
|Los Angeles, CA||Good Samaritan Hospital||no longer recruiting|
|Los Angeles, CA||UCLA / Jonsson Comprehensive Cancer Center||terminated|
|Riverside, CA||Compassionate Cancer Care Medical Group||no longer recruiting|
|Whittier, CA||American Institute of Research||no longer recruiting|
|Denver, CO||Centura Health Research Center||no longer recruiting|
|Golden, CO||Western Oncology & Hematology||no longer recruiting|
|Brooksville, FL||Cancer Care Centers of Florida: Brooksville||no longer recruiting|
|Ft Lauderdale, FL||Broward Oncology Associates||no longer recruiting|
|Gainesville, FL||University of Florida, Shands Cancer Center||no longer recruiting|
|Jacksonville, FL||Cancer Specialists of North Florida||no longer recruiting|
|Miami, FL||Advanced Pharma CR, LLC||no longer recruiting|
|New Port Richey, FL||Cancer Care Centers of Florida||no longer recruiting|
|Ocala, FL||Ocala Cancer Institute||no longer recruiting|
|Rockledge, FL||Cancer Care Centers of Brevard||no longer recruiting|
|Athens, GA||Northeast Georgia Cancer Care, LLC||no longer recruiting|
|Dublin, GA||Dublin Hematology & Oncology Care||no longer recruiting|
|Post Falls, ID||Kootenai Cancer Center||no longer recruiting|
|Chicago, IL||Northwestern University, Robert H. Lurie Comprehensive Cancer Center||no longer recruiting|
|Galesburg, IL||Medical & Surgical Specialists, LLC||no longer recruiting|
|Skokie, IL||Edward H. Kaplan, M.D., & Associates||no longer recruiting|
|Evansville, IN||Deaconess Clinic||no longer recruiting|
|Fort Wayne, IN||Fort Wayne Oncology & Hematology, Inc||no longer recruiting|
|Goshen, IN||IU Health Goshen||no longer recruiting|
|Indianapolis, IN||Indiana University / Melvin and Bren Simon Cancer Center||no longer recruiting|
|Indianapolis, IN||IU Health Central Indiana Cancer Centers||no longer recruiting|
|Indianapolis, IN||Community Regional Cancer Center||no longer recruiting|
|Lafayette, IN||Horizon Oncology Research||no longer recruiting|
|Muncie, IN||IU Health at Ball Memorial Hospital Cancer Center||no longer recruiting|
|Munster, IN||Monroe Medical Associates||no longer recruiting|
|Newburgh, IN||Oncology Hematology Associates of SW Indiana||no longer recruiting|
|South Bend, IN||Northern Indiana Cancer Research Consortium||no longer recruiting|
|Sioux City, IA||Siouxland Hematology Oncology Associates, LLP, Nylen Cancer Center||no longer recruiting|
|Wichita, KS||Cancer Center of Kansas||no longer recruiting|
|Hazard, KY||Kentucky Cancer Clinic||no longer recruiting|
|Paducah, KY||Purchase Cancer Group||no longer recruiting|
|Baton Rouge, LA||Medical Oncology LLC||no longer recruiting|
|Metairie, LA||Metairie Oncologists||no longer recruiting|
|Boston, MA||Tufts Medical Center||no longer recruiting|
|Ann Arbor, MI||St. Joseph Mercy Hospital||no longer recruiting|
|Grand Rapids, MI||Cancer and Hematology Centers of Western Michigan||no longer recruiting|
|Wyoming, MI||Metro Health Cancer Care||no longer recruiting|
|Rochester, MN||Mayo Clinic||no longer recruiting|
|Bozeman, MT||Bozeman Deaconness Cancer Center||no longer recruiting|
|Great Falls, MT||Sletten Cancer Specialists||no longer recruiting|
|Omaha, NE||Methodist Cancer Center||no longer recruiting|
|Lebanon, NH||Dartmouth Hitchcock Medical Center||no longer recruiting|
|Manchester, NH||Dartmouth-Hitchcock Medical Center||no longer recruiting|
|Elizabeth, NJ||Trinitas Regional Medical Center||no longer recruiting|
|Somerville, NJ||Somerset Hematology Oncology Associates||no longer recruiting|
|Albuquerque, NM||University of New Mexico Cancer Center||no longer recruiting|
|Albuquerque, NM||Presbyterian Medical Group||no longer recruiting|
|Albuquerque, NM||University of New Mexico Cancer Center: Albuquerque||no longer recruiting|
|Albany, NY||New York Oncology Hematology, PC||no longer recruiting|
|Buffalo, NY||Roswell Park Cancer Institute||completed|
|Lake Success, NY||NYU Langone Arena Oncology||no longer recruiting|
|New York, NY||Tisch Cancer Institute at Mount Sinai Medical Center||no longer recruiting|
|Nyack, NY||Hematology Oncology Associates of Rockland||no longer recruiting|
|Pinehurst, NC||First Health of the Carolinas||no longer recruiting|
|Middletown, OH||Signal Point Clinical Research Center||no longer recruiting|
|Wooster, OH||Lawrence M. Stallings, M.D.||no longer recruiting|
|Oklahoma City, OK||Mercy Physicians Of Oklahoma||no longer recruiting|
|Springfield, OR||Willamette Valley Cancer Institute||no longer recruiting|
|Danville, PA||Geisinger Medical Center||no longer recruiting|
|Gettysburg, PA||Gettysburg Cancer Center||no longer recruiting|
|Pittsburgh, PA||Allegheny Cancer Center||no longer recruiting|
|State College, PA||Mount Nittany Medical Center||no longer recruiting|
|West Reading, PA||Berks Hematology Oncology Associates||no longer recruiting|
|Cranston, RI||Hematology and Oncology Associates of Rhode Island||no longer recruiting|
|Charleston, SC||Medical University of South Carolina||completed|
|Hilton Head, SC||South Carolina Cancer Specialists||no longer recruiting|
|Germantown, TN||The Jones Clinic, PC||no longer recruiting|
|Austin, TX||Texas Oncology: Austin North||no longer recruiting|
|Bedford, TX||Texas Oncology: Bedford||no longer recruiting|
|Dallas, TX||Texas Oncology, PA||no longer recruiting|
|Fort Worth, TX||Texas Oncology: Fort Worth||no longer recruiting|
|Houston, TX||Texas Oncology: Houston Memorial City||no longer recruiting|
|Houston, TX||Methodist Hospital Research Institute||no longer recruiting|
|Houston, TX||Houston Cancer Center||no longer recruiting|
|Lubbock, TX||Joe Arrington Cancer Research and Treatment Center||no longer recruiting|
|San Antonio, TX||University of Texas Health Science Center at San Antonio||completed|
|Lynchburg, VA||Lynchburg Hematology Oncology Clinic, Inc.||no longer recruiting|
|Bremerton, WA||Harrison HealthPartners Bremerton Hematology & Oncology||no longer recruiting|
|Kirkland, WA||Cascade Cancer Center||no longer recruiting|
|Seattle, WA||University of Washington, Seattle Cancer Care Alliance||no longer recruiting|
|Spokane, WA||Rockwood Clinic||no longer recruiting|
|Milwaukee, WI||University of Wisconsin, Clinical Cancer Center||no longer recruiting|
|Camperdown, Australia||Royal Prince Alfred Hospital: Sydney Cancer Centre||no longer recruiting|
|Randwick, Australia||Prince of Wales Hospital||no longer recruiting|
|Wahroonga, Australia||Sydney Adventist Hospital Ltd.||no longer recruiting|
|Greenslopes, Australia||Gallipoli Medical Research Foundation: Greenslopes Private Hospital||no longer recruiting|
|Herston, Australia||Royal Brisbane & Women's Hospital||no longer recruiting|
|Wolloongabba, Australia||Princess Alexandra Hospital||no longer recruiting|
|Adelaide, Australia||Royal Adelaide Hospital||no longer recruiting|
|Kurralta Park, Australia||Ashford Cancer Centre||no longer recruiting|
|Launceston, Australia||Gallipoli Medical Research Foundation: Launceston General Hospital||no longer recruiting|
|Frankston, Australia||Peninsula Oncology Centre||no longer recruiting|
|Heidelberg, Australia||Austin Hospital||no longer recruiting|
|Melbourne, Australia||Alfred Hospital||no longer recruiting|
|Perth, Australia||Royal Perth Hospital||no longer recruiting|
|Singapore, Singapore||National Cancer Centre Singapore||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Phase I: To determine maximum tolerated dose and toxicities of BNC105P in combination with everolimus.
time frame: 12 months
Phase II: Improvement in 6-month PFS with the addition of BNC105P to everolimus.
time frame: 12 months
Phase I: To determine the response rate of BNC105P in combination with everolimus.
time frame: 12 months
Phase I: To evaluate the pharmacokinetic (PK) profile for BNC105P in combination with everolimus
time frame: 12 months
Phase II: To determine response rate with combination therapy compared to everolimus alone
time frame: 12 months
Phase II: To determine PFS with BNC105P alone in patients progressing on everolimus.
time frame: 12 months
Phase II: To evaluate the adverse events of the everolimus and BNC105P when administered as a combination or sequential regimen.
time frame: 12 months
Phase II: To determine the overall survival, up to a maximum of 5 years from registration for protocol therapy.
time frame: 60 months
Exploratory Objective: To determine the correlation of PFS with biomarkers
time frame: 24 months
Male or female participants at least 18 years old.
- 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.
- 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.
|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|
|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.|
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