BNC105P in Combination With Everolimus/Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma
7 juli 2022 uppdaterad av: Hoosier Cancer Research Network
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
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
154
Fas
- Fas 2
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
New South Wales
-
Camperdown, New South Wales, Australien, 2050
- Royal Prince Alfred Hospital: Sydney Cancer Centre
-
Randwick, New South Wales, Australien, 2031
- Prince of Wales Hospital
-
Wahroonga, New South Wales, Australien, 2076
- Sydney Adventist Hospital Ltd.
-
-
Queensland
-
Greenslopes, Queensland, Australien, 4120
- Gallipoli Medical Research Foundation: Greenslopes Private Hospital
-
Herston, Queensland, Australien, 4029
- Royal Brisbane & Women's Hospital
-
Woolloongabba, Queensland, Australien, 4201
- Princess Alexandra Hospital
-
-
South Australia
-
Adelaide, South Australia, Australien, 5000
- Royal Adelaide Hospital
-
Kurralta Park, South Australia, Australien, 5037
- Ashford Cancer Centre
-
-
Tasmania
-
Launceston, Tasmania, Australien, 7250
- Gallipoli Medical Research Foundation: Launceston General Hospital
-
-
Victoria
-
Frankston, Victoria, Australien, 3199
- Peninsula Oncology Centre
-
Heidelberg, Victoria, Australien, 3084
- Austin Hospital
-
Melbourne, Victoria, Australien, 3004
- Alfred Hospital
-
-
Western Australia
-
Perth, Western Australia, Australien, 6000
- Royal Perth Hospital
-
-
-
-
Alabama
-
Muscle Shoals, Alabama, Förenta staterna, 35661
- Northwest Alabama Cancer Center
-
-
Arkansas
-
Hot Springs, Arkansas, Förenta staterna, 71913
- Genesis Cancer Center
-
-
California
-
Burbank, California, Förenta staterna, 91505
- Providence Health System: Roy and Patricia Disney Family Cancer Center
-
Corona, California, Förenta staterna, 92879
- Compassionate Cancer Care Medical Group, Inc.
-
Corona, California, Förenta staterna, 92879
- Compassionate Cancer Care Medical Group
-
Duarte, California, Förenta staterna, 91010
- City of Hope
-
Fountain Valley, California, Förenta staterna, 92708
- Robert A. Moss, M.D., FACP, Inc.
-
Fresno, California, Förenta staterna, 93720
- California Cancer Associates for Research and Excellence
-
Greenbrae, California, Förenta staterna, 94904
- Marin Specialty Care
-
Los Angeles, California, Förenta staterna, 90017
- Good Samaritan Hospital
-
Los Angeles, California, Förenta staterna, 90095
- UCLA Med - Hematology & Oncology
-
Riverside, California, Förenta staterna, 92501
- Compassionate Cancer Care Medical Group
-
Whittier, California, Förenta staterna, 90603
- American Institute of Research
-
-
Colorado
-
Denver, Colorado, Förenta staterna, 80210
- Centura Health Research Center
-
Golden, Colorado, Förenta staterna, 80401
- Western Oncology & Hematology
-
-
Florida
-
Brooksville, Florida, Förenta staterna, 34613
- Cancer Care Centers of Florida: Brooksville
-
Fort Lauderdale, Florida, Förenta staterna, 33308
- Broward Oncology Associates
-
Gainesville, Florida, Förenta staterna, 32610
- University of Florida, Shands Cancer Center
-
Jacksonville, Florida, Förenta staterna, 32256
- Cancer Specialists of North Florida
-
Miami, Florida, Förenta staterna, 33136
- Advanced Pharma Cr, Llc
-
New Port Richey, Florida, Förenta staterna, 34652
- Cancer Care Centers of Florida
-
Ocala, Florida, Förenta staterna, 34471
- Ocala Cancer Institute
-
Rockledge, Florida, Förenta staterna, 32955
- Cancer Care Centers of Brevard
-
-
Georgia
-
Athens, Georgia, Förenta staterna, 30607
- Northeast Georgia Cancer Care, LLC
-
Dublin, Georgia, Förenta staterna, 31021
- Dublin Hematology & Oncology Care
-
-
Idaho
-
Post Falls, Idaho, Förenta staterna, 83854
- Kootenai Cancer Center
-
-
Illinois
-
Chicago, Illinois, Förenta staterna, 60611
- Northwestern University, Robert H. Lurie Comprehensive Cancer Center
-
Galesburg, Illinois, Förenta staterna, 61401
- Medical & Surgical Specialists, LLC
-
Skokie, Illinois, Förenta staterna, 60076
- Edward H. Kaplan, M.D., & Associates
-
-
Indiana
-
Evansville, Indiana, Förenta staterna, 47713
- Deaconess Clinic
-
Fort Wayne, Indiana, Förenta staterna, 46815
- Fort Wayne Oncology & Hematology, Inc
-
Goshen, Indiana, Förenta staterna, 46527
- IU Health Goshen
-
Indianapolis, Indiana, Förenta staterna, 46202
- Indiana University Melvin and Bren Simon Cancer Center
-
Indianapolis, Indiana, Förenta staterna, 46219
- IU Health Central Indiana Cancer Centers
-
Indianapolis, Indiana, Förenta staterna, 46256
- Community Regional Cancer Center
-
Lafayette, Indiana, Förenta staterna, 47905
- Horizon Oncology Research
-
Muncie, Indiana, Förenta staterna, 47303
- IU Health at Ball Memorial Hospital Cancer Center
-
Munster, Indiana, Förenta staterna, 46321
- Monroe Medical Associates
-
Newburgh, Indiana, Förenta staterna, 47630
- Oncology Hematology Associates of SW Indiana
-
South Bend, Indiana, Förenta staterna, 46601
- Northern Indiana Cancer Research Consortium
-
-
Iowa
-
Sioux City, Iowa, Förenta staterna, 51101
- Siouxland Hematology Oncology Associates, LLP, Nylen Cancer Center
-
-
Kansas
-
Wichita, Kansas, Förenta staterna, 67214
- Cancer Center of Kansas
-
-
Kentucky
-
Hazard, Kentucky, Förenta staterna, 41701
- Kentucky Cancer Clinic
-
Paducah, Kentucky, Förenta staterna, 42001
- Purchase Cancer Group
-
-
Louisiana
-
Baton Rouge, Louisiana, Förenta staterna, 70809
- Medical Oncology LLC
-
Metairie, Louisiana, Förenta staterna, 70006
- Metairie Oncologists
-
-
Massachusetts
-
Boston, Massachusetts, Förenta staterna, 02111
- Tufts Medical Center
-
-
Michigan
-
Ann Arbor, Michigan, Förenta staterna, 48106
- St. Joseph Mercy Hospital
-
Grand Rapids, Michigan, Förenta staterna, 49546
- Cancer and Hematology Centers of Western Michigan
-
Wyoming, Michigan, Förenta staterna, 49519
- Metro Health Cancer Care
-
-
Minnesota
-
Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic
-
-
Montana
-
Bozeman, Montana, Förenta staterna, 59715
- Bozeman Deaconness Cancer Center
-
Great Falls, Montana, Förenta staterna, 59405
- Sletten Cancer Specialists
-
-
Nebraska
-
Omaha, Nebraska, Förenta staterna, 68114
- Methodist Cancer Center
-
-
New Hampshire
-
Manchester, New Hampshire, Förenta staterna, 03102
- Dartmouth-Hitchcock Medical Center
-
-
New Jersey
-
Elizabeth, New Jersey, Förenta staterna, 07202
- Trinitas Regional Medical Center
-
Somerville, New Jersey, Förenta staterna, 08876
- Somerset Hematology Oncology Associates
-
-
New Mexico
-
Albuquerque, New Mexico, Förenta staterna, 87110
- Presbyterian Medical Group
-
Albuquerque, New Mexico, Förenta staterna, 87131
- University of New Mexico Cancer Center: Albuquerque
-
-
New York
-
Albany, New York, Förenta staterna, 12208
- New York Oncology Hematology, PC
-
Buffalo, New York, Förenta staterna, 14263
- Roswell Park Cancer Institute
-
Lake Success, New York, Förenta staterna, 11042
- NYU Langone Arena Oncology
-
New York, New York, Förenta staterna, 10029
- Tisch Cancer Institute at Mount Sinai Medical Center
-
Nyack, New York, Förenta staterna, 10960
- Hematology Oncology Associates of Rockland
-
-
North Carolina
-
Pinehurst, North Carolina, Förenta staterna, 28374
- First Health of the Carolinas
-
-
Ohio
-
Middletown, Ohio, Förenta staterna, 45042
- Signal Point Clinical Research Center
-
Wooster, Ohio, Förenta staterna, 44691
- Lawrence M. Stallings, M.D.
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Förenta staterna, 73120
- Mercy Physicians Of Oklahoma
-
-
Oregon
-
Springfield, Oregon, Förenta staterna, 97477
- Willamette Valley Cancer Institute
-
-
Pennsylvania
-
Danville, Pennsylvania, Förenta staterna, 17822
- Geisinger Medical Center
-
Gettysburg, Pennsylvania, Förenta staterna, 17235
- Gettysburg Cancer Center
-
Pittsburgh, Pennsylvania, Förenta staterna, 15212
- Allegheny Cancer Center
-
State College, Pennsylvania, Förenta staterna, 16803
- Mount Nittany Medical Center
-
West Reading, Pennsylvania, Förenta staterna, 19611
- Berks Hematology Oncology Associates
-
-
Rhode Island
-
Cranston, Rhode Island, Förenta staterna, 02920
- Hematology and Oncology Associates of Rhode Island
-
-
South Carolina
-
Charleston, South Carolina, Förenta staterna, 29425
- MUSC Hollings Cancer Center
-
Hilton Head Island, South Carolina, Förenta staterna, 29926
- South Carolina Cancer Specialists
-
-
Tennessee
-
Germantown, Tennessee, Förenta staterna, 38138
- The Jones Clinic, PC
-
-
Texas
-
Austin, Texas, Förenta staterna, 78758
- Texas Oncology: Austin North
-
Bedford, Texas, Förenta staterna, 76022
- Texas Oncology: Bedford
-
Dallas, Texas, Förenta staterna, 75246
- Texas Oncology, PA
-
Fort Worth, Texas, Förenta staterna, 76104
- Texas Oncology: Fort Worth
-
Houston, Texas, Förenta staterna, 77030
- Methodist Hospital Research Institute
-
Houston, Texas, Förenta staterna, 77024
- Texas Oncology: Houston Memorial City
-
Houston, Texas, Förenta staterna, 77055
- Houston Cancer Center
-
Lubbock, Texas, Förenta staterna, 79410
- Joe Arrington Cancer Research and Treatment Center
-
San Antonio, Texas, Förenta staterna, 78229
- CTRC at the UT Health Science Center at San Antonio
-
-
Virginia
-
Lynchburg, Virginia, Förenta staterna, 24501
- Lynchburg Hematology Oncology Clinic, Inc.
-
-
Washington
-
Bremerton, Washington, Förenta staterna, 98310
- Harrison HealthPartners Bremerton Hematology & Oncology
-
Kirkland, Washington, Förenta staterna, 98034
- Cascade Cancer Center
-
Seattle, Washington, Förenta staterna, 98109
- University of Washington, Seattle Cancer Care Alliance
-
Seattle, Washington, Förenta staterna, 98109
- Group Health Medical Centers
-
Spokane, Washington, Förenta staterna, 99204
- Rockwood Clinic
-
-
Wisconsin
-
Milwaukee, Wisconsin, Förenta staterna, 53226
- University of Wisconsin, Clinical Cancer Center
-
-
-
-
-
Singapore, Singapore, 169610
- National Cancer Centre Singapore
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv 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
|
|
Aktiv 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Phase I: Maximum Tolerated Dose of BNC105P in Combination With Everolimus.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Phase I: Response Rate of BNC105P in Combination With Everolimus.
Tidsram: 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.
Tidsram: 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
Tidsram: 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.
Tidsram: 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.
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Studiestol: Thomas Hutson, D.O., Hoosier Cancer Research Network
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 januari 2010
Primärt slutförande (Faktisk)
1 december 2016
Avslutad studie (Faktisk)
1 december 2016
Studieregistreringsdatum
Först inskickad
15 december 2009
Först inskickad som uppfyllde QC-kriterierna
15 december 2009
Första postat (Uppskatta)
17 december 2009
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
11 juli 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
7 juli 2022
Senast verifierad
1 april 2017
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter histologisk typ
- Neoplasmer
- Urologiska neoplasmer
- Urogenitala neoplasmer
- Neoplasmer efter plats
- Njursjukdomar
- Urologiska sjukdomar
- Adenocarcinom
- Neoplasmer, körtel och epitel
- Neoplasmer i njurarna
- Karcinom, njurcell
- Carcinom
- Läkemedels fysiologiska effekter
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Everolimus
Andra studie-ID-nummer
- HOG GU09-145
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .