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An Open Label Phase II Trial of BIBW 2992 in Patients With HER2-negative Metastatic Breast Cancer

5 de dezembro de 2013 atualizado por: Boehringer Ingelheim

An Open Label Phase II Trial to Assess the Efficacy and Safety of a Once Daily Oral Dose of 50 mg BIBW 2992 in Two Cohorts of Patients With HER2-negative Metastatic Breast Cancer After Failure of no More Than Two Chemotherapy Regimen

The purpose of this trial is to evaluate the efficacy, safety and pharmacokinetics of BIBW 2992, a dual, irreversible EGFR- and HER2-inhibitor, in two cohorts of patients with HER2-negative breast cancer after failure of no more than three regimen of prior chemotherapy.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

50

Estágio

  • Fase 2

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

  • Alemanha
      • Berlin, Alemanha
        • 1200.10.49005 Boehringer Ingelheim Investigational Site
      • Düsseldorf, Alemanha
        • 1200.10.49007 Boehringer Ingelheim Investigational Site
      • Erlangen, Alemanha
        • 1200.10.49008 Boehringer Ingelheim Investigational Site
      • Essen, Alemanha
        • 1200.10.49010 Boehringer Ingelheim Investigational Site
      • Kiel, Alemanha
        • 1200.10.49003 Boehringer Ingelheim Investigational Site
      • Mainz, Alemanha
        • 1200.10.49004 Boehringer Ingelheim Investigational Site
      • München, Alemanha
        • 1200.10.49001 Boehringer Ingelheim Investigational Site
      • Wiesbaden, Alemanha
        • 1200.10.49006 Boehringer Ingelheim Investigational Site
  • Bélgica
      • Brussel, Bélgica
        • 1200.10.3208 Boehringer Ingelheim Investigational Site
      • Bruxelles, Bélgica
        • 1200.10.3201 Boehringer Ingelheim Investigational Site
      • Charleroi, Bélgica
        • 1200.10.3203 Boehringer Ingelheim Investigational Site
      • Gent, Bélgica
        • 1200.10.3205 Boehringer Ingelheim Investigational Site
      • Leuven, Bélgica
        • 1200.10.3204 Boehringer Ingelheim Investigational Site
      • Wilrijk, Bélgica
        • 1200.10.3206 Boehringer Ingelheim Investigational Site

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

Fêmea

Descrição

Inclusion criteria:

Inclusion Criteria:

  • Female patients age 18 years or older
  • Histologically proven breast cancer after failure or relapse of no more than three lines of chemotherapy including adjuvant, irrespective of prior hormone therapy metastatic disease (stage IV);
  • HER2-negative patients (HER2 1+ or negative, or HER2 2+ and FISH negative)
  • At least one measurable tumour lesion (RECIST);
  • Availability of tumour samples
  • Written informed consent that is consistent with ICH-GCP guidelines and local law
  • Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score 0 - 2.

Exclusion criteria:

Exclusion Criteria:

  • Active infectious disease
  • Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhoea
  • Serious illness, concomitant non-oncological disease or mental problems considered by the investigator to be incompatible with the protocol
  • Active/symptomatic brain metastases
  • Cardiac left ventricular function with resting ejection fraction < 50% (below upper limit of normal)
  • ANC less than 1500/mm3 platelet count less than 100 000/mm3
  • Bilirubin greater than 1.5 mg /dl (>26 and#61549 mol /L, SI unit equivalent)
  • AST and ALT greater than 2.5 times the upper limit of normal or greater 5 times the upper limit of normal in case of known liver metastases
  • Serum creatinine greater than 1.5 mg/dl (>132 and#61549 mol/L, SI unit equivalent)
  • Patients who are sexually active and unwilling to use a medically acceptable method of contraception
  • Pregnancy or breast-feeding
  • Concomitant treatment with other investigational drugs or other anti-cancer-therapy during this study and/or during the past two/four weeks, prior to the first treatment with the trial drug. Concurrent treatment with biphosphonates is allowed
  • Previous treatment with trastuzumab, EGFR-, or EGFR/HER2-inhibitors patients unable to comply with the protocol
  • Active alcohol or drug abuse
  • Other malignancy within the past 5 years

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: Diagnóstico
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: BIBW 2992
high dose once daily
Medicamento: BIBW 2992
high dose once daily

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Objective Response (OR)
Prazo: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
OR is defined as complete response (CR) and partial response (PR) and was assessed according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST). OR was primary endpoint only for Cohort B.
Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Clinical Benefit (CB)
Prazo: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
CB was defined as CR, PR or stable disease (SD) for a minimum of 4 months (modified CB) and was assessed according to RECIST 1.0 criteria. CB was primary endpoint only for Cohort A.
Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Clinical Benefit (CB)
Prazo: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
CB was defined as CR, PR or stable disease (SD) for a minimum of 4 months (modified CB) and was assessed according to RECIST 1.0 criteria. CB was secondary endpoint only for Cohort B as it was primary endpoint for Cohort A.
Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Time to OR
Prazo: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST 1.0 criteria.
Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Duration of OR
Prazo: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Duration of OR was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death was objectively documented.
Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Progression-free Survival (PFS)
Prazo: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first. It was assessed according to RECIST 1.0 criteria as well as by the investigators assessment. Median time results from unstratified Kaplan-Meier estimates.
Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Overall Survival (OS)
Prazo: From randomisation to end of follow-up.
OS is defined as time from randomisation to death.
From randomisation to end of follow-up.
Significant Change in Cardiac Left Ventricular Ejection Fraction (LVEF)
Prazo: Baseline and last assessment
LVEF as measured by echocardiography or Multiple Gated Acquisition (MUGA) scan. MUGA scan is an useful noninvasive tool for assessing the function of the heart. Significant change in LVEF values was defined as >=20 percent decrease from baseline or to below lower limit of normal, which was defined as 50 percent.
Baseline and last assessment
Best Change From Baseline in ECOG Performance Status
Prazo: baseline till end of treatment
Best change from baseline in ECOG (Eastern Cooperative Oncology Group) performance status. ECOG is measured as score between 0 (fully active) and 5 (dead).
baseline till end of treatment
Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 29 (Cpre,ss,29)
Prazo: day 29
Cpre,ss,29 represents the pre-dose concentration of afatinib in plasma at steady state on day 29.
day 29

Colaboradores e Investigadores

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

Patrocinador

Boehringer Ingelheim

Publicações e links úteis

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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 novembro de 2006

Conclusão Primária (Real)

1 de maio de 2009

Datas de inscrição no estudo

Enviado pela primeira vez

22 de janeiro de 2007

Enviado pela primeira vez que atendeu aos critérios de CQ

22 de janeiro de 2007

Primeira postagem (Estimativa)

23 de janeiro de 2007

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

31 de dezembro de 2013

Última atualização enviada que atendeu aos critérios de controle de qualidade

5 de dezembro de 2013

Última verificação

1 de agosto de 2013

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 1200.10
  • 2006-002018-36 (Número EudraCT: EudraCT)

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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