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BNC105P in Combination With Everolimus/Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma

7. juli 2022 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Nyrecellekarcinom

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

154

Fase

Fase 2
Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Australien
- 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
Forenede Stater
- Alabama
  - Muscle Shoals, Alabama, Forenede Stater, 35661
    - Northwest Alabama Cancer Center
- Arkansas
  - Hot Springs, Arkansas, Forenede Stater, 71913
    - Genesis Cancer Center
- California
  - Burbank, California, Forenede Stater, 91505
    - Providence Health System: Roy and Patricia Disney Family Cancer Center
  - Corona, California, Forenede Stater, 92879
    - Compassionate Cancer Care Medical Group, Inc.
  - Corona, California, Forenede Stater, 92879
    - Compassionate Cancer Care Medical Group
  - Duarte, California, Forenede Stater, 91010
    - City of Hope
  - Fountain Valley, California, Forenede Stater, 92708
    - Robert A. Moss, M.D., FACP, Inc.
  - Fresno, California, Forenede Stater, 93720
    - California Cancer Associates for Research and Excellence
  - Greenbrae, California, Forenede Stater, 94904
    - Marin Specialty Care
  - Los Angeles, California, Forenede Stater, 90017
    - Good Samaritan Hospital
  - Los Angeles, California, Forenede Stater, 90095
    - UCLA Med - Hematology & Oncology
  - Riverside, California, Forenede Stater, 92501
    - Compassionate Cancer Care Medical Group
  - Whittier, California, Forenede Stater, 90603
    - American Institute of Research
- Colorado
  - Denver, Colorado, Forenede Stater, 80210
    - Centura Health Research Center
  - Golden, Colorado, Forenede Stater, 80401
    - Western Oncology & Hematology
- Florida
  - Brooksville, Florida, Forenede Stater, 34613
    - Cancer Care Centers of Florida: Brooksville
  - Fort Lauderdale, Florida, Forenede Stater, 33308
    - Broward Oncology Associates
  - Gainesville, Florida, Forenede Stater, 32610
    - University of Florida, Shands Cancer Center
  - Jacksonville, Florida, Forenede Stater, 32256
    - Cancer Specialists of North Florida
  - Miami, Florida, Forenede Stater, 33136
    - Advanced Pharma CR, LLC
  - New Port Richey, Florida, Forenede Stater, 34652
    - Cancer Care Centers of Florida
  - Ocala, Florida, Forenede Stater, 34471
    - Ocala Cancer Institute
  - Rockledge, Florida, Forenede Stater, 32955
    - Cancer Care Centers of Brevard
- Georgia
  - Athens, Georgia, Forenede Stater, 30607
    - Northeast Georgia Cancer Care, LLC
  - Dublin, Georgia, Forenede Stater, 31021
    - Dublin Hematology & Oncology Care
- Idaho
  - Post Falls, Idaho, Forenede Stater, 83854
    - Kootenai Cancer Center
- Illinois
  - Chicago, Illinois, Forenede Stater, 60611
    - Northwestern University, Robert H. Lurie Comprehensive Cancer Center
  - Galesburg, Illinois, Forenede Stater, 61401
    - Medical & Surgical Specialists, LLC
  - Skokie, Illinois, Forenede Stater, 60076
    - Edward H. Kaplan, M.D., & Associates
- Indiana
  - Evansville, Indiana, Forenede Stater, 47713
    - Deaconess Clinic
  - Fort Wayne, Indiana, Forenede Stater, 46815
    - Fort Wayne Oncology & Hematology, Inc
  - Goshen, Indiana, Forenede Stater, 46527
    - IU Health Goshen
  - Indianapolis, Indiana, Forenede Stater, 46202
    - Indiana University Melvin and Bren Simon Cancer Center
  - Indianapolis, Indiana, Forenede Stater, 46219
    - IU Health Central Indiana Cancer Centers
  - Indianapolis, Indiana, Forenede Stater, 46256
    - Community Regional Cancer Center
  - Lafayette, Indiana, Forenede Stater, 47905
    - Horizon Oncology Research
  - Muncie, Indiana, Forenede Stater, 47303
    - IU Health at Ball Memorial Hospital Cancer Center
  - Munster, Indiana, Forenede Stater, 46321
    - Monroe Medical Associates
  - Newburgh, Indiana, Forenede Stater, 47630
    - Oncology Hematology Associates of SW Indiana
  - South Bend, Indiana, Forenede Stater, 46601
    - Northern Indiana Cancer Research Consortium
- Iowa
  - Sioux City, Iowa, Forenede Stater, 51101
    - Siouxland Hematology Oncology Associates, LLP, Nylen Cancer Center
- Kansas
  - Wichita, Kansas, Forenede Stater, 67214
    - Cancer Center of Kansas
- Kentucky
  - Hazard, Kentucky, Forenede Stater, 41701
    - Kentucky Cancer Clinic
  - Paducah, Kentucky, Forenede Stater, 42001
    - Purchase Cancer Group
- Louisiana
  - Baton Rouge, Louisiana, Forenede Stater, 70809
    - Medical Oncology LLC
  - Metairie, Louisiana, Forenede Stater, 70006
    - Metairie Oncologists
- Massachusetts
  - Boston, Massachusetts, Forenede Stater, 02111
    - Tufts Medical Center
- Michigan
  - Ann Arbor, Michigan, Forenede Stater, 48106
    - St. Joseph Mercy Hospital
  - Grand Rapids, Michigan, Forenede Stater, 49546
    - Cancer and Hematology Centers of Western Michigan
  - Wyoming, Michigan, Forenede Stater, 49519
    - Metro Health Cancer Care
- Minnesota
  - Rochester, Minnesota, Forenede Stater, 55905
    - Mayo Clinic
- Montana
  - Bozeman, Montana, Forenede Stater, 59715
    - Bozeman Deaconness Cancer Center
  - Great Falls, Montana, Forenede Stater, 59405
    - Sletten Cancer Specialists
- Nebraska
  - Omaha, Nebraska, Forenede Stater, 68114
    - Methodist Cancer Center
- New Hampshire
  - Manchester, New Hampshire, Forenede Stater, 03102
    - Dartmouth-Hitchcock Medical Center
- New Jersey
  - Elizabeth, New Jersey, Forenede Stater, 07202
    - Trinitas Regional Medical Center
  - Somerville, New Jersey, Forenede Stater, 08876
    - Somerset Hematology Oncology Associates
- New Mexico
  - Albuquerque, New Mexico, Forenede Stater, 87110
    - Presbyterian Medical Group
  - Albuquerque, New Mexico, Forenede Stater, 87131
    - University of New Mexico Cancer Center: Albuquerque
- New York
  - Albany, New York, Forenede Stater, 12208
    - New York Oncology Hematology, PC
  - Buffalo, New York, Forenede Stater, 14263
    - Roswell Park Cancer Institute
  - Lake Success, New York, Forenede Stater, 11042
    - NYU Langone Arena Oncology
  - New York, New York, Forenede Stater, 10029
    - Tisch Cancer Institute at Mount Sinai Medical Center
  - Nyack, New York, Forenede Stater, 10960
    - Hematology Oncology Associates of Rockland
- North Carolina
  - Pinehurst, North Carolina, Forenede Stater, 28374
    - First Health of the Carolinas
- Ohio
  - Middletown, Ohio, Forenede Stater, 45042
    - Signal Point Clinical Research Center
  - Wooster, Ohio, Forenede Stater, 44691
    - Lawrence M. Stallings, M.D.
- Oklahoma
  - Oklahoma City, Oklahoma, Forenede Stater, 73120
    - Mercy Physicians Of Oklahoma
- Oregon
  - Springfield, Oregon, Forenede Stater, 97477
    - Willamette Valley Cancer Institute
- Pennsylvania
  - Danville, Pennsylvania, Forenede Stater, 17822
    - Geisinger Medical Center
  - Gettysburg, Pennsylvania, Forenede Stater, 17235
    - Gettysburg Cancer Center
  - Pittsburgh, Pennsylvania, Forenede Stater, 15212
    - Allegheny Cancer Center
  - State College, Pennsylvania, Forenede Stater, 16803
    - Mount Nittany Medical Center
  - West Reading, Pennsylvania, Forenede Stater, 19611
    - Berks Hematology Oncology Associates
- Rhode Island
  - Cranston, Rhode Island, Forenede Stater, 02920
    - Hematology and Oncology Associates of Rhode Island
- South Carolina
  - Charleston, South Carolina, Forenede Stater, 29425
    - MUSC Hollings Cancer Center
  - Hilton Head Island, South Carolina, Forenede Stater, 29926
    - South Carolina Cancer Specialists
- Tennessee
  - Germantown, Tennessee, Forenede Stater, 38138
    - The Jones Clinic, PC
- Texas
  - Austin, Texas, Forenede Stater, 78758
    - Texas Oncology: Austin North
  - Bedford, Texas, Forenede Stater, 76022
    - Texas Oncology: Bedford
  - Dallas, Texas, Forenede Stater, 75246
    - Texas Oncology, PA
  - Fort Worth, Texas, Forenede Stater, 76104
    - Texas Oncology: Fort Worth
  - Houston, Texas, Forenede Stater, 77030
    - Methodist Hospital Research Institute
  - Houston, Texas, Forenede Stater, 77024
    - Texas Oncology: Houston Memorial City
  - Houston, Texas, Forenede Stater, 77055
    - Houston Cancer Center
  - Lubbock, Texas, Forenede Stater, 79410
    - Joe Arrington Cancer Research and Treatment Center
  - San Antonio, Texas, Forenede Stater, 78229
    - CTRC at The UT Health Science Center at San Antonio
- Virginia
  - Lynchburg, Virginia, Forenede Stater, 24501
    - Lynchburg Hematology Oncology Clinic, Inc.
- Washington
  - Bremerton, Washington, Forenede Stater, 98310
    - Harrison HealthPartners Bremerton Hematology & Oncology
  - Kirkland, Washington, Forenede Stater, 98034
    - Cascade Cancer Center
  - Seattle, Washington, Forenede Stater, 98109
    - University of Washington, Seattle Cancer Care Alliance
  - Seattle, Washington, Forenede Stater, 98109
    - Group Health Medical Centers
  - Spokane, Washington, Forenede Stater, 99204
    - Rockwood Clinic
- Wisconsin
  - Milwaukee, Wisconsin, Forenede Stater, 53226
    - University of Wisconsin, Clinical Cancer Center
Singapore
- - Singapore, Singapore, 169610
    - National Cancer Centre Singapore

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Ingen (Åben etiket)

Antal våben

Våben og indgreb

Deltagergruppe / 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	Medicin: Everolimus Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals Medicin: BNC105P 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.	Medicin: Everolimus Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals Medicin: BNC105P BNC105P, up to 16 mg/m^2

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Phase I: Maximum Tolerated Dose of BNC105P in Combination With Everolimus. Tidsramme: 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. Tidsramme: 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. Tidsramme: 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

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Phase I: Response Rate of BNC105P in Combination With Everolimus. Tidsramme: 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. Tidsramme: 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 Tidsramme: 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. Tidsramme: 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. Tidsramme: 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 Tidsramme: 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 Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hoosier Cancer Research Network

Samarbejdspartnere

Bionomics Limited

Efterforskere

Studiestol: Thomas Hutson, D.O., Hoosier Cancer Research Network

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle 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.

Hjælpsomme links

Hoosier Cancer Research Network Homepage

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2010

Primær færdiggørelse (Faktiske)

1. december 2016

Studieafslutning (Faktiske)

1. december 2016

Datoer for studieregistrering

Først indsendt

15. december 2009

Først indsendt, der opfyldte QC-kriterier

15. december 2009

Først opslået (Skøn)

17. december 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juli 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juli 2022

Sidst verificeret

1. april 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

HOG GU09-145

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Nyrecellekarcinom

Universitaire Ziekenhuizen KU Leuven

Ukendt

Helkropsdiffusionsvægtet magnetisk resonansbilleddannelse til iscenesættelse og behandlingsforudsigelse af lymfom

Lymfom | Hodgkin lymfom | Non-Hodgkin lymfom (follikulært, diffust B-cel lymfom, PTLD og Mantle Cel lymfom)

Belgien
National Cancer Institute (NCI)

Aktiv, ikke rekrutterende

Cisplatin og gemcitabinhydrochlorid med eller uden berzosertib til behandling af patienter med metastatisk urothelial cancer

Metastatisk blæreurothelial karcinom | Metastatisk Ureter Urothelial Carcinoma | Stadie IV Blære Urothelial Carcinoma AJCC v7 | Metastatisk nyrebækken og Ureter Urothelial Carcinoma

Forenede Stater
Association Pour La Recherche des Thérapeutiques...

Afsluttet

Et BIOmarkør-drevet forsøg med Nivolumab og Ipilimumab eller VEGFR tKi i naiv metastatisk nyrekræft (BIONIKK)

Clear Cell Metastatic Renal Cell Carcinoma

Frankrig
Universitaire Ziekenhuizen KU Leuven

Afsluttet

Øget renal clearance hos den voksne ikke-kritisk syge kirurgiske patient: en prospektiv punktprævalansundersøgelse (ARCPPS)

Forekomst af Augmented Renal Clearance | Risikofaktorer for øget renal clearance

Belgien
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)

Aktiv, ikke rekrutterende

Forsøger at finde den korrekte behandlingslængde med immunkontrolpunktterapi (IMAGINE)

Metastatisk blæreurothelial karcinom | Metastatisk nyrebækken Urothelial Carcinom | Metastatisk Ureter Urothelial Carcinoma | Metastatisk Urethral Urothelial Carcinoma | Metastatisk Urothelial Carcinom | Lokalt avanceret blæreurothelial karcinom | Lokalt avanceret nyrebækken Urothelial Carcinoma | Lokalt... og andre forhold

Forenede Stater
Roswell Park Cancer Institute
Iovance Biotherapeutics, Inc.

Trukket tilbage

Adoptiv celleterapi med (LN-145) i kombination med Pembrolizumab til behandling af patienter med inoperabel eller metastatisk overgangscellekræft, som har fejlet Cisplatin-baseret kemoterapi

Metastatisk blæreurothelial karcinom | Metastatisk nyrebækken Urothelial Carcinom | Metastatisk Ureter Urothelial Carcinoma | Metastatisk Urethral Urothelial Carcinoma | Uoperabelt nyrebækken Urothelial Carcinom | Uoperabelt Ureter Urothelial Carcinoma

Forenede Stater
The First People's Hospital of Changzhou

Ikke rekrutterer endnu

DC-vaccineterapi kombineret med cytokin-induceret dræbercelle i behandling

Renal neoplasma
NicOx

Afsluttet

Effekt af gentagen dosering af Naproxcinod på renal hæmodynamisk og på natriumbalance hos raske frivillige før og efter en enkelt dosis furosemid

Renal hæmodynamik
Medical University of Vienna

Afsluttet

Effekt af forhøjede plasma-fri-fedtsyrer på nyrernes hæmodynamiske parametre

Glomerulær filtreringshastighed | Fedtsyrer, ikke-esterificerede | Renal Cirkulation | Renal Plasma Flow

Østrig
All India Institute of Medical Sciences, New Delhi

Ukendt

Evaluering af 3DCRT versus IGRT og analyse af tidlig respons ved hoved- og halskræft.

HOVED- OG NAKKEKRÆFT | CARCINOMA OROPHARYNX | CARCINOMA PYRIFORM SINUS | CARCINOMA LARYNX

Indien

Kliniske forsøg med Everolimus

Novartis Pharmaceuticals

Afsluttet

Sikkerhed og effektivitet af RAD001 + TACE i lokaliseret uoperabelt HCC (TRACER)

Hepatocellulært karcinom

Hong Kong, Taiwan, Thailand
Novartis Pharmaceuticals

Afsluttet

Effekt og sikkerhed af RAD001 hos patienter på 18 år og derover med angiomyolipom associeret med enten tuberøs sklerosekompleks (TSC) eller sporadisk lymfangioleiomyomatose (LAM) (EXIST-2)

Lymfangioleiomyomatose (LAM) | Tuberøs sklerosekompleks (TSC)

Forenede Stater, Det Forenede Kongerige, Tyskland, Italien, Den Russiske Føderation, Holland, Japan, Canada, Polen, Frankrig, Spanien
German Breast Group
Novartis

Afsluttet

Everolimus Beyond Progress for patienter, der havde fremskridt under Everolimus og Exemestan (Evelyn)

Metastatisk brystkræft

Tyskland
The Netherlands Cancer Institute

Aktiv, ikke rekrutterende

Cisplatinum og Everolimus hos patienter med metastatisk eller ikke-operabel NEC af ekstrapulmonal oprindelse

Neuroendokrine karcinomer

Holland
University of Luebeck

Afsluttet

Bioresorberbare vaskulære stilladser versus stenter hos patienter med kronisk total okklusion (SCORE-CTO)

Koronararteriesygdom

Tyskland
Novartis Pharmaceuticals

Afsluttet

Sikkerhed og tolerabilitet af Pasireotid LAR i kombination med Everolimus i avancerede metastatiske NET (COOPERATE-1)

Gastroenteropancreatisk neuroendokrin tumor i lunge- eller gastroenteropancreatisk system

Tyskland
Guangdong Provincial People's Hospital
Novartis

Ukendt

Sikkerheds- og tolerabilitetsprofil for RAD001 dagligt hos kinesiske patienter med avanceret pulmonal neuroendokrin tumor

Neuroendokrine tumorer | Carcinoid tumor

Kina
Asan Medical Center

Afsluttet

RAD001 (Everolimus) Salvage Monotherapy in Advanced Gastric Cancer (AGC) Who Failed Standard First-line Treatment

Neoplasma i maven

Korea, Republikken
Leiden University Medical Center

Ukendt

Everolimus in Treating Patients With Progressive or Recurrent, Unresectable, or Metastatic Thyroid Cancer

Hoved- og halskræft

Holland
Novartis Pharmaceuticals

Afsluttet

Everolimus Post Pazopanib-behandling ved metastatisk eller avanceret nyrecellekarcinom (CATChEz)

Karcinom, nyrecelle

Australien, Korea, Republikken

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

Studieoversigt

Status

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Undersøgelsestype

Tilmelding (Faktiske)

Fase

Kontakter og lokationer

Studiesteder

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal våben

Våben og indgreb

Deltagergruppe / Arm

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Samarbejdspartnere

Efterforskere

Publikationer og nyttige links

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Studer store datoer

Studiestart

Primær færdiggørelse (Faktiske)

Studieafslutning (Faktiske)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Skøn)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Kliniske forsøg med Nyrecellekarcinom

Kliniske forsøg med Everolimus

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Ghana

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer