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

7 de julho de 2022 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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 de estudo

Intervencional

Inscrição (Real)

154

Estágio

  • Fase 2
  • Fase 1

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Combination Arm A: Everolimus + BNC105P
Combination Arm A: Everolimus 10 mg, BNC105P MTD (from Phase 1 study) 21 day cycle
Medicamento: Everolimus
Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals
Medicamento: BNC105P
BNC105P, up to 16 mg/m^2
Comparador Ativo: 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.
Medicamento: Everolimus
Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals
Medicamento: BNC105P
BNC105P, up to 16 mg/m^2

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Phase I: Maximum Tolerated Dose of BNC105P in Combination With Everolimus.
Prazo: 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.
Prazo: 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.
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Phase I: Response Rate of BNC105P in Combination With Everolimus.
Prazo: 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.
Prazo: 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
Prazo: 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.
Prazo: 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.
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Hoosier Cancer Research Network

Colaboradores

Bionomics Limited

Investigadores

  • Cadeira de estudo: Thomas Hutson, D.O., Hoosier Cancer Research Network

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de janeiro de 2010

Conclusão Primária (Real)

1 de dezembro de 2016

Conclusão do estudo (Real)

1 de dezembro de 2016

Datas de inscrição no estudo

Enviado pela primeira vez

15 de dezembro de 2009

Enviado pela primeira vez que atendeu aos critérios de CQ

15 de dezembro de 2009

Primeira postagem (Estimativa)

17 de dezembro de 2009

Atualizações de registro de estudo

Última Atualização Postada (Real)

11 de julho de 2022

Última atualização enviada que atendeu aos critérios de controle de qualidade

7 de julho de 2022

Última verificação

1 de abril de 2017

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • HOG GU09-145

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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