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

7 luglio 2022 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

154

Fase

  • Fase 2
  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital: Sydney Cancer Centre
      • Randwick, New South Wales, Australia, 2031
        • Prince of Wales Hospital
      • Wahroonga, New South Wales, Australia, 2076
        • Sydney Adventist Hospital Ltd.
    • Queensland
      • Greenslopes, Queensland, Australia, 4120
        • Gallipoli Medical Research Foundation: Greenslopes Private Hospital
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane & Women's Hospital
      • Woolloongabba, Queensland, Australia, 4201
        • Princess Alexandra Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
      • Kurralta Park, South Australia, Australia, 5037
        • Ashford Cancer Centre
    • Tasmania
      • Launceston, Tasmania, Australia, 7250
        • Gallipoli Medical Research Foundation: Launceston General Hospital
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Peninsula Oncology Centre
      • Heidelberg, Victoria, Australia, 3084
        • Austin Hospital
      • Melbourne, Victoria, Australia, 3004
        • Alfred Hospital
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital
  • Singapore
      • Singapore, Singapore, 169610
        • National Cancer Centre Singapore
  • Stati Uniti
    • Alabama
      • Muscle Shoals, Alabama, Stati Uniti, 35661
        • Northwest Alabama Cancer Center
    • Arkansas
      • Hot Springs, Arkansas, Stati Uniti, 71913
        • Genesis Cancer Center
    • California
      • Burbank, California, Stati Uniti, 91505
        • Providence Health System: Roy and Patricia Disney Family Cancer Center
      • Corona, California, Stati Uniti, 92879
        • Compassionate Cancer Care Medical Group, Inc.
      • Corona, California, Stati Uniti, 92879
        • Compassionate Cancer Care Medical Group
      • Duarte, California, Stati Uniti, 91010
        • City of Hope
      • Fountain Valley, California, Stati Uniti, 92708
        • Robert A. Moss, M.D., FACP, Inc.
      • Fresno, California, Stati Uniti, 93720
        • California Cancer Associates for Research and Excellence
      • Greenbrae, California, Stati Uniti, 94904
        • Marin Specialty Care
      • Los Angeles, California, Stati Uniti, 90017
        • Good Samaritan Hospital
      • Los Angeles, California, Stati Uniti, 90095
        • UCLA Med - Hematology & Oncology
      • Riverside, California, Stati Uniti, 92501
        • Compassionate Cancer Care Medical Group
      • Whittier, California, Stati Uniti, 90603
        • American Institute of Research
    • Colorado
      • Denver, Colorado, Stati Uniti, 80210
        • Centura Health Research Center
      • Golden, Colorado, Stati Uniti, 80401
        • Western Oncology & Hematology
    • Florida
      • Brooksville, Florida, Stati Uniti, 34613
        • Cancer Care Centers of Florida: Brooksville
      • Fort Lauderdale, Florida, Stati Uniti, 33308
        • Broward Oncology Associates
      • Gainesville, Florida, Stati Uniti, 32610
        • University of Florida, Shands Cancer Center
      • Jacksonville, Florida, Stati Uniti, 32256
        • Cancer Specialists of North Florida
      • Miami, Florida, Stati Uniti, 33136
        • Advanced Pharma CR, LLC
      • New Port Richey, Florida, Stati Uniti, 34652
        • Cancer Care Centers of Florida
      • Ocala, Florida, Stati Uniti, 34471
        • Ocala Cancer Institute
      • Rockledge, Florida, Stati Uniti, 32955
        • Cancer Care Centers of Brevard
    • Georgia
      • Athens, Georgia, Stati Uniti, 30607
        • Northeast Georgia Cancer Care, LLC
      • Dublin, Georgia, Stati Uniti, 31021
        • Dublin Hematology & Oncology Care
    • Idaho
      • Post Falls, Idaho, Stati Uniti, 83854
        • Kootenai Cancer Center
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60611
        • Northwestern University, Robert H. Lurie Comprehensive Cancer Center
      • Galesburg, Illinois, Stati Uniti, 61401
        • Medical & Surgical Specialists, LLC
      • Skokie, Illinois, Stati Uniti, 60076
        • Edward H. Kaplan, M.D., & Associates
    • Indiana
      • Evansville, Indiana, Stati Uniti, 47713
        • Deaconess Clinic
      • Fort Wayne, Indiana, Stati Uniti, 46815
        • Fort Wayne Oncology & Hematology, Inc
      • Goshen, Indiana, Stati Uniti, 46527
        • IU Health Goshen
      • Indianapolis, Indiana, Stati Uniti, 46202
        • Indiana University Melvin and Bren Simon Cancer Center
      • Indianapolis, Indiana, Stati Uniti, 46219
        • IU Health Central Indiana Cancer Centers
      • Indianapolis, Indiana, Stati Uniti, 46256
        • Community Regional Cancer Center
      • Lafayette, Indiana, Stati Uniti, 47905
        • Horizon Oncology Research
      • Muncie, Indiana, Stati Uniti, 47303
        • IU Health at Ball Memorial Hospital Cancer Center
      • Munster, Indiana, Stati Uniti, 46321
        • Monroe Medical Associates
      • Newburgh, Indiana, Stati Uniti, 47630
        • Oncology Hematology Associates of SW Indiana
      • South Bend, Indiana, Stati Uniti, 46601
        • Northern Indiana Cancer Research Consortium
    • Iowa
      • Sioux City, Iowa, Stati Uniti, 51101
        • Siouxland Hematology Oncology Associates, LLP, Nylen Cancer Center
    • Kansas
      • Wichita, Kansas, Stati Uniti, 67214
        • Cancer Center of Kansas
    • Kentucky
      • Hazard, Kentucky, Stati Uniti, 41701
        • Kentucky Cancer Clinic
      • Paducah, Kentucky, Stati Uniti, 42001
        • Purchase Cancer Group
    • Louisiana
      • Baton Rouge, Louisiana, Stati Uniti, 70809
        • Medical Oncology LLC
      • Metairie, Louisiana, Stati Uniti, 70006
        • Metairie Oncologists
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02111
        • Tufts Medical Center
    • Michigan
      • Ann Arbor, Michigan, Stati Uniti, 48106
        • St. Joseph Mercy Hospital
      • Grand Rapids, Michigan, Stati Uniti, 49546
        • Cancer and Hematology Centers of Western Michigan
      • Wyoming, Michigan, Stati Uniti, 49519
        • Metro Health Cancer Care
    • Minnesota
      • Rochester, Minnesota, Stati Uniti, 55905
        • Mayo Clinic
    • Montana
      • Bozeman, Montana, Stati Uniti, 59715
        • Bozeman Deaconness Cancer Center
      • Great Falls, Montana, Stati Uniti, 59405
        • Sletten Cancer Specialists
    • Nebraska
      • Omaha, Nebraska, Stati Uniti, 68114
        • Methodist Cancer Center
    • New Hampshire
      • Manchester, New Hampshire, Stati Uniti, 03102
        • Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Elizabeth, New Jersey, Stati Uniti, 07202
        • Trinitas Regional Medical Center
      • Somerville, New Jersey, Stati Uniti, 08876
        • Somerset Hematology Oncology Associates
    • New Mexico
      • Albuquerque, New Mexico, Stati Uniti, 87110
        • Presbyterian Medical Group
      • Albuquerque, New Mexico, Stati Uniti, 87131
        • University of New Mexico Cancer Center: Albuquerque
    • New York
      • Albany, New York, Stati Uniti, 12208
        • New York Oncology Hematology, PC
      • Buffalo, New York, Stati Uniti, 14263
        • Roswell Park Cancer Institute
      • Lake Success, New York, Stati Uniti, 11042
        • NYU Langone Arena Oncology
      • New York, New York, Stati Uniti, 10029
        • Tisch Cancer Institute at Mount Sinai Medical Center
      • Nyack, New York, Stati Uniti, 10960
        • Hematology Oncology Associates of Rockland
    • North Carolina
      • Pinehurst, North Carolina, Stati Uniti, 28374
        • First Health of the Carolinas
    • Ohio
      • Middletown, Ohio, Stati Uniti, 45042
        • Signal Point Clinical Research Center
      • Wooster, Ohio, Stati Uniti, 44691
        • Lawrence M. Stallings, M.D.
    • Oklahoma
      • Oklahoma City, Oklahoma, Stati Uniti, 73120
        • Mercy Physicians Of Oklahoma
    • Oregon
      • Springfield, Oregon, Stati Uniti, 97477
        • Willamette Valley Cancer Institute
    • Pennsylvania
      • Danville, Pennsylvania, Stati Uniti, 17822
        • Geisinger Medical Center
      • Gettysburg, Pennsylvania, Stati Uniti, 17235
        • Gettysburg Cancer Center
      • Pittsburgh, Pennsylvania, Stati Uniti, 15212
        • Allegheny Cancer Center
      • State College, Pennsylvania, Stati Uniti, 16803
        • Mount Nittany Medical Center
      • West Reading, Pennsylvania, Stati Uniti, 19611
        • Berks Hematology Oncology Associates
    • Rhode Island
      • Cranston, Rhode Island, Stati Uniti, 02920
        • Hematology and Oncology Associates of Rhode Island
    • South Carolina
      • Charleston, South Carolina, Stati Uniti, 29425
        • MUSC Hollings Cancer Center
      • Hilton Head Island, South Carolina, Stati Uniti, 29926
        • South Carolina Cancer Specialists
    • Tennessee
      • Germantown, Tennessee, Stati Uniti, 38138
        • The Jones Clinic, PC
    • Texas
      • Austin, Texas, Stati Uniti, 78758
        • Texas Oncology: Austin North
      • Bedford, Texas, Stati Uniti, 76022
        • Texas Oncology: Bedford
      • Dallas, Texas, Stati Uniti, 75246
        • Texas Oncology, PA
      • Fort Worth, Texas, Stati Uniti, 76104
        • Texas Oncology: Fort Worth
      • Houston, Texas, Stati Uniti, 77030
        • Methodist Hospital Research Institute
      • Houston, Texas, Stati Uniti, 77024
        • Texas Oncology: Houston Memorial City
      • Houston, Texas, Stati Uniti, 77055
        • Houston Cancer Center
      • Lubbock, Texas, Stati Uniti, 79410
        • Joe Arrington Cancer Research and Treatment Center
      • San Antonio, Texas, Stati Uniti, 78229
        • CTRC at the UT Health Science Center at San Antonio
    • Virginia
      • Lynchburg, Virginia, Stati Uniti, 24501
        • Lynchburg Hematology Oncology Clinic, Inc.
    • Washington
      • Bremerton, Washington, Stati Uniti, 98310
        • Harrison HealthPartners Bremerton Hematology & Oncology
      • Kirkland, Washington, Stati Uniti, 98034
        • Cascade Cancer Center
      • Seattle, Washington, Stati Uniti, 98109
        • University of Washington, Seattle Cancer Care Alliance
      • Seattle, Washington, Stati Uniti, 98109
        • Group Health Medical Centers
      • Spokane, Washington, Stati Uniti, 99204
        • Rockwood Clinic
    • Wisconsin
      • Milwaukee, Wisconsin, Stati Uniti, 53226
        • University of Wisconsin, Clinical Cancer Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Combination Arm A: Everolimus + BNC105P
Combination Arm A: Everolimus 10 mg, BNC105P MTD (from Phase 1 study) 21 day cycle
Droga: Everolimus
Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals
Droga: BNC105P
BNC105P, up to 16 mg/m^2
Comparatore attivo: 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.
Droga: Everolimus
Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals
Droga: BNC105P
BNC105P, up to 16 mg/m^2

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Phase I: Maximum Tolerated Dose of BNC105P in Combination With Everolimus.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Phase I: Response Rate of BNC105P in Combination With Everolimus.
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Hoosier Cancer Research Network

Collaboratori

Bionomics Limited

Investigatori

  • Cattedra di studio: Thomas Hutson, D.O., Hoosier Cancer Research Network

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 gennaio 2010

Completamento primario (Effettivo)

1 dicembre 2016

Completamento dello studio (Effettivo)

1 dicembre 2016

Date di iscrizione allo studio

Primo inviato

15 dicembre 2009

Primo inviato che soddisfa i criteri di controllo qualità

15 dicembre 2009

Primo Inserito (Stima)

17 dicembre 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 luglio 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 luglio 2022

Ultimo verificato

1 aprile 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • HOG GU09-145

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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