- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02182206
An Dose Escalation Study of Treatment With BIBF 1120 in Patients With Advanced Solid Tumours
17 de julho de 2014 atualizado por: Boehringer Ingelheim
A Phase I Open Label Dose Escalation Study of Continuous Once-daily or Twice Daily Oral Treatment With BIBF 1120 in Patients With Advanced Solid Tumours
Maximum Tolerated Dose (MTD), safety, pharmacokinetics, efficacy of BIBF 1120, pharmacodynamic parameters (Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI))
Visão geral do estudo
Tipo de estudo
Intervencional
Inscrição (Real)
50
Estágio
- Fase 1
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:
- Male or female patients with confirmed diagnosis of advanced, non resectable and/or metastatic solid tumours, who have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who were not amenable to established forms of treatment
- Measurable tumour deposits by one or more techniques (X-ray), Computed Tomography (CT), Magnetic Resonance Imaging (MRI))
- At least one tumour lesion considered suitable for DCE-MRI as determined by discussion with centre radiologist. This lesion must not have been previously irradiated
- Age 18 years or older
- Life expectancy of at least three months
- Written informed consent given consistent with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines
- Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1
- Patients completely recovered from any therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies
Exclusion Criteria:
- Surgical procedures within four weeks of initiating treatment with the study drug, active ulcers, or injuries with incomplete wound healing
- Active infectious disease
- Uncontrolled, severe hypertension (diastolic BP (Blood Pressure) >100 mmHg, Systolic BP>180 mmHg)
- Gastrointestinal disorders that might have interfered with the resorption of the study drug
- Serious illness or concomitant non-oncological disease considered by the investigator to have been incompatible with the protocol
- Brain metastases requiring therapy
- Absolute neutrophil count less than 1500/mm3
- Platelet count less than 100 000/mm3
- Bilirubin greater than 1.5 mg/dl (>26 μmol/L, System International (SI) unit equivalent)
- Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than three times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal)
- Serum creatinine greater than 1.5 mg/dl (>132μmol/L, SI unit equivalent)
- Women and men who were sexually active and unwilling to use a medically acceptable method of contraception
- Pregnancy or breastfeeding
- Treatment with other investigational drugs; chemotherapy or hormone therapy (excluding Lutenizing Hormone Releasing Hormone (LHRH) agonists or bisphosphonates provided the lesion for MR (magnetic resonance) imaging did not arise from bone) or participation in another clinical study within the past four weeks before start of therapy or concomitantly with this study
- Patients unable to comply with the protocol
- Active alcohol or drug abuse
- History of autoimmune disease
- History of allergy to gadolinium or other intravenous (IV) contrast agent, indwelling medical devices or any other condition that would preclude MR scanning
- Patients requiring the ongoing use of dexamethasone, anti-histamines, anti-hypertensives or medications for the control of cardiac failure such as diuretics, where there was likely to be a need for alteration of dose during the study period. Dose adjustment of such medications may have independently altered vascular permeability or blood flow
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: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: BIBF 1120
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Maximum Tolerated Dose (MTD) of BIBF 1120
Prazo: Up to 7 months
|
Up to 7 months
|
Incidence and intensity of Adverse Events according to common toxicity criteria (CTC) associated with increasing doses of BIBF 1120
Prazo: Up to 7 months
|
Up to 7 months
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
Transfer constant (Ktrans)
Prazo: Screening, day 2, 28 and 56
|
Screening, day 2, 28 and 56
|
Extravascular-extracellular leakage volume (ve)
Prazo: Screening, day 2, 28 and 56
|
Screening, day 2, 28 and 56
|
Area under the gadolinium concentration time curve [0-60 seconds] (AUC[Gd])
Prazo: Screening, day 2, 28 and 56
|
Screening, day 2, 28 and 56
|
Relative blood volume (rBV)
Prazo: Screening, day 2, 28 and 56
|
Screening, day 2, 28 and 56
|
Mean transit time (MTT)
Prazo: Screening, day 2, 28 and 56
|
Screening, day 2, 28 and 56
|
Relative blood flow (rBF)
Prazo: Screening, day 2, 28 and 56
|
Screening, day 2, 28 and 56
|
Volume of tumour showing contrast uptake
Prazo: Screening, day 2, 28 and 56
|
Screening, day 2, 28 and 56
|
Volume of tumour showing no contrast uptake
Prazo: Screening, day 2, 28 and 56
|
Screening, day 2, 28 and 56
|
Restricted diffusion
Prazo: Screening, day 2, 28 and 56
|
Screening, day 2, 28 and 56
|
Vessel size index
Prazo: Screening, day 2, 28 and 56
|
Screening, day 2, 28 and 56
|
Change in Eastern Cooperative Oncology Group (ECOG) performance score
Prazo: Baseline, up to 7 months
|
Baseline, up to 7 months
|
Objective tumour responses according to the response evaluation criteria in solid tumour (RECIST)
Prazo: Baseline, up to 7 months
|
Baseline, up to 7 months
|
Area under the plasma concentration-time curve following the first dose of uniform intervals τ over the time interval from zero to 24 hours (AUCτ,1)
Prazo: up to 24 hours after the first dose on day 1
|
up to 24 hours after the first dose on day 1
|
Area under the plasma concentration-time curve over the time interval from zero to the time of the last quantifiable drug concentration (AUC0-tz)
Prazo: up to 24 hours after the first dose on day 1
|
up to 24 hours after the first dose on day 1
|
Area under the plasma concentration-time curve over the time interval from zero extrapolated to infinity (AUC0-∞)
Prazo: up to 24 hours after the first dose on day 1
|
up to 24 hours after the first dose on day 1
|
Maximum measured plasma concentration following the first dose of uniform intervals τ (Cmax,1)
Prazo: up to 24 hours after the first dose on day 1
|
up to 24 hours after the first dose on day 1
|
Time from dosing to the maximum plasma concentration following the first dose of uniform intervals τ (tmax,1)
Prazo: up to 24 hours after the first dose on day 1
|
up to 24 hours after the first dose on day 1
|
Terminal half-life (t1/2)
Prazo: up to 24 hours after the first dose on day 1
|
up to 24 hours after the first dose on day 1
|
Mean residence time (MRTpo)
Prazo: up to 24 hours after the first dose on day 1
|
up to 24 hours after the first dose on day 1
|
Apparent clearance (CL/F)
Prazo: up to 24 hours after the first dose on day 1
|
up to 24 hours after the first dose on day 1
|
Apparent volume of distribution during the terminal phase (Vz/F)
Prazo: up to 24 hours after the first dose on day 1
|
up to 24 hours after the first dose on day 1
|
Area under the plasma concentration-time curve over the dosing interval τ (24 h) at steady state (AUCτ,ss)
Prazo: up to 24 hours after drug administration on day 27
|
up to 24 hours after drug administration on day 27
|
Predose plasma concentration at steady state immediately before dosing (Cpre,ss)
Prazo: up to 24 hours after drug administration on day 27
|
up to 24 hours after drug administration on day 27
|
Maximum plasma concentration at steady state over the dosing interval τ (Cmax,ss)
Prazo: up to 24 hours after drug administration on day 27
|
up to 24 hours after drug administration on day 27
|
Time from dosing to the maximum plasma concentration at steady state over the dosing interval τ (tmax,ss)
Prazo: up to 24 hours after drug administration on day 27
|
up to 24 hours after drug administration on day 27
|
Terminal half-life at steady state (t1/2,ss)
Prazo: up to 24 hours after drug administration on day 27
|
up to 24 hours after drug administration on day 27
|
Apparent clearance at steady state (CL/F,ss)
Prazo: up to 24 hours after drug administration on day 27
|
up to 24 hours after drug administration on day 27
|
Mean residence time at steady state (MRTpo,ss),
Prazo: up to 24 hours after drug administration on day 27
|
up to 24 hours after drug administration on day 27
|
Apparent volume of distribution during the terminal phase at steady state (Vz/F,ss)
Prazo: up to 24 hours after drug administration on day 27
|
up to 24 hours after drug administration on day 27
|
Accumulation ratio (RA)
Prazo: up to 24 hours after drug administration on day 27
|
up to 24 hours after drug administration on day 27
|
Minimum measured plasma concentration following the first dose of uniform intervals τ (Cmin,1)
Prazo: up to 24 hours after the first dose on day 1
|
up to 24 hours after the first dose on day 1
|
Time from first dosing to the minimum plasma concentration over the dosing interval τ (tmin,1)
Prazo: up to 24 hours after the first dose on day 1
|
up to 24 hours after the first dose on day 1
|
Minimum measured plasma concentration at steady state over the dosing interval τ (Cmin,ss)
Prazo: up to 24 hours after drug administration on day 27
|
up to 24 hours after drug administration on day 27
|
Time from last dosing to the minimum plasma concentration at steady state over the dosing interval τ (tmin,ss)
Prazo: up to 24 hours after drug administration on day 27
|
up to 24 hours after drug administration on day 27
|
Predose concentration of the 15th dose over the dosing interval τ (Cpre,15)
Prazo: pre-dose on day 15
|
pre-dose on day 15
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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.
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 junho de 2003
Conclusão Primária (Real)
1 de junho de 2005
Datas de inscrição no estudo
Enviado pela primeira vez
2 de julho de 2014
Enviado pela primeira vez que atendeu aos critérios de CQ
2 de julho de 2014
Primeira postagem (Estimativa)
8 de julho de 2014
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
18 de julho de 2014
Última atualização enviada que atendeu aos critérios de controle de qualidade
17 de julho de 2014
Última verificação
1 de julho de 2014
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 1199.3
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 .
Ensaios clínicos em Tumores
-
Aadi Bioscience, Inc.RecrutamentoTumor Sólido Avançado | Tumor | Tumor SólidoEstados Unidos
-
Sorrento Therapeutics, Inc.RetiradoTumor Sólido | Tumor Sólido Recidivante | Tumor Refratário
-
Memorial Sloan Kettering Cancer CenterRecrutamentoTumor Sólido | Tumor Sólido, Adulto | Tumor Sólido, Não Especificado, AdultoEstados Unidos
-
Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterRecrutamentoTumor Sólido | Tumor Sólido, Adulto | Tumor Sólido, Não Especificado, AdultoEstados Unidos, Porto Rico
-
Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterRecrutamentoTumor Sólido | Tumor Sólido, Adulto | Tumor Sólido, Não Especificado, AdultoEstados Unidos, Porto Rico
-
RemeGen Co., Ltd.ConcluídoTumor Sólido Metastático | Tumor Sólido Localmente Avançado | Tumor sólido irressecávelAustrália
-
Yonsei UniversityMerck KGaA, Darmstadt, GermanyAtivo, não recrutandoTumor de Mutação Positiva PD-L1 | Tumor de Mutação Positiva EBV | Tumor Mutação MSI-H | Tumor de mutação POLE/POLD1Republica da Coréia
-
Baodong QinRecrutamento
-
National Health Research Institutes, TaiwanNational Cheng-Kung University HospitalRecrutamento
-
Elpiscience Biopharma, Ltd.Shanghai Junshi Bioscience Co., Ltd.RecrutamentoNeoplasias | Tumor Sólido | Tumor malignoChina
Ensaios clínicos em BIBF 1120
-
Boehringer IngelheimRescindidoBIBF 1120 em combinação com pemetrexede em câncer avançado de pulmão de células não pequenas (NSCLC)Carcinoma pulmonar de células não pequenasJapão
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)ConcluídoCarcinoma recorrente do corpo uterino | Adenocarcinoma de Células Claras do Endométrio | Adenocarcinoma Seroso Endometrial | Carcinoma Indiferenciado de Endométrio | Adenocarcinoma Endometrial | Carcinoma de Células de Transição Endometrial | Adenocarcinoma mucinoso endometrial | Carcinoma Espinocelular... e outras condiçõesEstados Unidos
-
Barbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)ConcluídoMesotelioma maligno pleural recorrente | Mesotelioma Pleural Estágio IVEstados Unidos
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); Boehringer IngelheimConcluídoCâncer de Pulmão de Células Não Pequenas Recorrente | Câncer de pulmão de células não pequenas em estágio IV | Câncer de pulmão de células escamosas | Câncer de pulmão de células não pequenas em estágio IIIEstados Unidos
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); Boehringer Ingelheim; National Comprehensive...ConcluídoCarcinoma de cólon recorrente | Carcinoma retal recorrente | Adenocarcinoma retal | Adenocarcinoma de cólon | Câncer de cólon estágio IVA | Câncer Retal Estágio IVA | Câncer de cólon estágio IVB | Câncer Retal Estágio IVBEstados Unidos
-
Boehringer IngelheimConcluídoNeoplasias prostáticas
-
Roswell Park Cancer InstituteNational Comprehensive Cancer NetworkConcluídoTumor Carcinóide | Neoplasia Neuroendócrina | Tumor Carcinóide MetastáticoEstados Unidos
-
Boehringer IngelheimConcluído
-
University College, LondonBoehringer IngelheimConcluídoCancro do ovário | Câncer de Trompa de FalópioReino Unido