BNC105P in Combination With Everolimus/Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma
NCT ID: NCT01034631
Last Updated: 2022-07-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
154 participants
INTERVENTIONAL
2010-01-31
2016-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Combination Arm A: Everolimus + BNC105P
Combination Arm A: Everolimus 10 mg, BNC105P MTD (from Phase 1 study) 21 day cycle
Everolimus
Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals
BNC105P
BNC105P, up to 16 mg/m\^2
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
Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals
BNC105P
BNC105P, up to 16 mg/m\^2
Interventions
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Everolimus
Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals
BNC105P
BNC105P, up to 16 mg/m\^2
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Bionomics Limited
INDUSTRY
Hoosier Cancer Research Network
OTHER
Responsible Party
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Principal Investigators
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Thomas Hutson, D.O.
Role: STUDY_CHAIR
Hoosier Cancer Research Network
Locations
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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
Countries
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References
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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.
Related Links
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Hoosier Cancer Research Network Homepage
Other Identifiers
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HOG GU09-145
Identifier Type: -
Identifier Source: org_study_id
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