- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00111787
Study Of Lapatinib In Combination With Paclitaxel In The Treatment Of Newly Diagnosed Inflammatory Breast Cancer
27 de maio de 2017 atualizado por: GlaxoSmithKline
A Phase II Study to Evaluate the Efficacy, Safety, and Pharmacodynamics of Lapatinib in Combination With Paclitaxel as Neoadjuvant Therapy in Patients With Newly Diagnosed Inflammatory Breast Cancer
This Study was designed to determine how effective and safe a new investigational drug, lapatinib, is in combination with paclitaxel in treating patients with newly diagnosed inflammatory breast cancer.
Tumor tissue collected pre-treatment, following 14 days of treatment and at the time of surgical resection will be examined for pathologic response and biologic activity by IHC (immunohistochemistry) within the tumor.
Treatment will consist of 14 days of lapatinib monotherapy followed by 12 weeks of combination therapy with lapatinib and paclitaxel.
Blood samples for hematology and chemistry panels, MUGA/ECHO exams and physical exams will be performed throughout the study to monitor safety.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
49
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
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New South Wales
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Campbelltown, New South Wales, Austrália, 2560
- GSK Investigational Site
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Liverpool, New South Wales, Austrália, 2170
- GSK Investigational Site
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Randwick, New South Wales, Austrália, 2031
- GSK Investigational Site
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Queensland
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South Brisbane, Queensland, Austrália, 4101
- GSK Investigational Site
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South Australia
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Bedford Park, South Australia, Austrália, 5042
- GSK Investigational Site
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Victoria
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Box Hill, Victoria, Austrália, 3128
- GSK Investigational Site
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Ringwood East, Victoria, Austrália, 3128
- GSK Investigational Site
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Ontario
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Toronto, Ontario, Canadá, M4N 3M5
- GSK Investigational Site
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Barcelona, Espanha, 08035
- GSK Investigational Site
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Girona, Espanha, 17007
- GSK Investigational Site
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Valencia, Espanha, 46010
- GSK Investigational Site
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Florida
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Miami, Florida, Estados Unidos, 33136
- GSK Investigational Site
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Illinois
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Chicago, Illinois, Estados Unidos, 60637
- GSK Investigational Site
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Zion, Illinois, Estados Unidos, 60099
- GSK Investigational Site
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Texas
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Houston, Texas, Estados Unidos, 77030
- GSK Investigational Site
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Bayonne, França, 64100
- GSK Investigational Site
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Lille Cedex, França, 59020
- GSK Investigational Site
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Paris cedex 13, França, 75651
- GSK Investigational Site
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Ramat Gan, Israel, 52621
- GSK Investigational Site
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Auckland, Nova Zelândia
- GSK Investigational Site
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London, Reino Unido, SW3 6JJ
- GSK Investigational Site
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Sfax, Tunísia, 3000
- GSK Investigational Site
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Sfax, Tunísia, 3029
- GSK Investigational Site
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Tunis, Tunísia, 1007
- GSK Investigational Site
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Tunis, Tunísia, 1004
- GSK Investigational Site
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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:
- Tumor accessible for multiple biopsies
- ECOG (Eastern Cooperative Oncology Group) performance status 0-2
- Adequate bone marrow
- Renal and hepatic function
- LVEF (left ventricular ejection fraction) greater than 0% based on ECHO (echocardiogram) or MUGA (multigated acquisition).
Exclusion criteria:
- Females who are pregnant or nursing.
- Any unstable, pre-existing major medical condition.
- Received an investigational drug within the past 4 weeks.
- Had major surgery in the past 2 weeks.
- Currently receiving amiodarone or has received amiodarone in the past 6 months.
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: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Overall study
A Single arm study with 2 cohorts of participants.
Cohort A consists of participants with tumors overexpressing HER2 and/or EGFR.
Cohort B consists of participants with tumors expressing EGFR without overexpressing HER2.
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Daily-monotherapy [1500 milligrams (mg)] for 14 days, then daily combination therapy (with weekly paclitaxel) for 12 weeks
Weekly (80mg/m^2) combination therapy (with daily Lapatinib) for 12 weeks
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Percentage of participants with pathologic complete response rate (pCR)
Prazo: Week 12
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pCR was defined as the percentage of participants who achieved an assessment of complete response (CR) following pathologic review of resected tissue.
CR was the disappearance of all target lesions.
Participants in each cohort with unknown or missing response (i.e., those that did not undergo surgery) were included in the denominator when calculating the percentage.
From an efficacy standpoint, the HER2+ population response was considered to be of special interest.
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Week 12
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Percentage of participants with pCR that underwent surgical resection
Prazo: Week 12
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pCR for participants that underwent surgical (surg) resection was defined as the percentage of participants within each cohort who achieved an assessment of CR following pathologic review of resected tissue.
CR was the disappearance of all target lesions.
Participants in each cohort that did not undergo surgical resection were excluded from the denominator when calculating the percentage.
From an efficacy standpoint, the HER2+ population response was considered to be of special interest.
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Week 12
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Percentage of participants with objective response rate (ORR) at the end of study (Response evaluation criteria in solid tumor [RECIST])
Prazo: Week 14
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ORR at the end of the study was defined as the number of participants within each cohort who had a confirmed CR or partial response (PR) at the end of the study divided by the total number of participants enrolled in each cohort.
CR was the disappearance of all target lesions.
PR was at least a 30 percent decrease in the sum of the longest diameter of target lesions, taking as a reference, the Baseline sum longest diameter.
Each participant's response was based on the investigator assessment of best response using RECIST criteria.
Participants in each cohort with unknown or missing response was treated as non-responders; i.e. they were included in the denominator when calculating the percentage.
From an efficacy standpoint, the HER2+ population was considered to be of special interest.
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Week 14
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Percentage of participants with ORR at the end of study (Clinically Evaluable Skin Disease Criteria)
Prazo: Week 14
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ORR at the end of the study was defined as the number of participants within each cohort who had a confirmed CR or PR at the end of the study divided by the total number of participants enrolled in each cohort.
CR was the disappearance of all target lesions.
PR was at least a 30 percent decrease in the sum of the longest diameter of target lesions, taking as a reference, the Baseline sum longest diameter.
Each participant's response was based on the investigator assessment of best response using Clinically Evaluable Skin Disease Criteria.
Participants in each cohort with unknown or missing response was treated as non-responders; i.e. they were included in the denominator when calculating the percentage.
From an efficacy standpoint, HER2+ population was considered to be of special interest.
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Week 14
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Percentage of participants with ORR at the end of study ('Best' of RECIST and Clinically Evaluable Skin Disease Criteria)
Prazo: Week 14
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ORR at the end of the study was defined as the number of participants within each cohort who had a confirmed CR or PR at the end of the study divided by the total number of participants enrolled in each cohort.
CR was the disappearance of all target lesions.
PR was at least a 30 percent decrease in the sum of the longest diameter of target lesions, taking as a reference, the Baseline sum longest diameter.
The best response of the participant was defined by the 'Best' combined response (RECIST and Clinically Evaluable Skin Disease Criteria) provided there is no evidence of disease progression.
Participants in each cohort with unknown or missing response was treated as non-responders; i.e. they were included in the denominator when calculating the percentage.
From an efficacy standpoint, the HER2+ population was considered to be special interest.
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Week 14
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Percentage of participants with investigator-Assessed Best Response at the end of monotherapy phase (Day 14) (Clinically Evaluable Skin Disease Criteria)
Prazo: Day 14
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ORR at the end of the monotherapy phase was defined as the percentage of participants within each cohort who had a confirmed CR or PR at the end of lapatinib monotherapy (Day 14) divided by the total number of participants enrolled in each cohort.
CR was the disappearance of all target lesions.
PR was at least a 30 percent decrease in the sum of the longest diameter of target lesions, taking as a reference, the Baseline sum longest diameter.
Each participant's response was based on the investigator assessment of best response using clinically evaluable skin disease criteria.
Participants in each cohort with unknown or missing response was treated as non-responders; i.e. they were included in the denominator when calculating the percentage.
From an efficacy standpoint, the HER2+ population was considered to be special interest.
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Day 14
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Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Prazo: Up to Week 14, surgical resection and post treatment
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An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
An SAE was defined as any untoward medical occurrence that, at any dose that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect, resulted in deterioration in left ventricular cardiac function and caused Grade 3 or 4 interstitial pneumonitis.
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Up to Week 14, surgical resection and post treatment
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Number of participants with shift from Baseline in hematological toxicity grade
Prazo: Day 14 and up to Week 23, surg resection and post treatment
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Hematology was summarized for hemoglobin (Hb), platelets, white blood cell count (WBC), neutrophils (Neu), lymphocytes by scheduled assessment and also according to the maximum common terminology criteria (CTC) toxicity grade.
Baseline was the most recent lab value prior to and within two weeks of the first dose of lapatinib.
Change from Baseline was calculated as the value at each visit minus Baseline value.
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Day 14 and up to Week 23, surg resection and post treatment
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Number of participants with shift from Baseline in clinical chemistry toxicity grade
Prazo: Day 14, Week 4, 8, 12, 16, 20, Surg resection and post treatment
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Clinical chemistry was summarized for sodium, potassium (K), bicarbonate (bicarb), albumin (alb), calcium, gamma glutamyl transferase (GGT), creatinine (creat), total bilirubin (TB), alkaline phosphatase (ALP), aspartate amino transferase (AST) and alanine amino transferase (ALT) by scheduled assessment and also according to the maximum CTC toxicity grade.
Baseline was the most recent lab value prior to and within two weeks of the first dose of lapatinib.
Change from Baseline was calculated as the value at each visit minus Baseline value.
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Day 14, Week 4, 8, 12, 16, 20, Surg resection and post treatment
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Change from Baseline in vital signs- Systolic blood pressure (SBP) and Diastolic blood pressure (DBP)
Prazo: Day 14, Week 1 and up to Week 24, surg resection and post treatment
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Vitals signs (SBP and DBP) were assessed from screening until the post treatment phase.
Baseline was the most recent blood pressure (BP) mean prior to the first dose of lapatinib.
Change from Baseline was calculated as the mean at each visit minus the mean at Baseline.
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Day 14, Week 1 and up to Week 24, surg resection and post treatment
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Change from Baseline in vital signs- Heart Rate (HR)
Prazo: Day 14, Week 1 and up to Week 24, surg resection and post treatment
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Vitals signs (HR) were assessed from screening until the post treatment phase.
Baseline was the most recent BP mean prior to the first dose of lapatinib.
Change from Baseline was calculated as the mean at each visit minus the mean at Baseline.
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Day 14, Week 1 and up to Week 24, surg resection and post treatment
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Change from Baseline in vital signs- Body temperature
Prazo: Day 14, Week 1 and up to Week 24, surg resection and post treatment
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Vitals signs (body temperature) were assessed from screening until the post treatment phase.
Baseline was the most recent BP mean prior to the first dose of lapatinib.
Change from Baseline was calculated as the mean at each visit minus the mean at Baseline.
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Day 14, Week 1 and up to Week 24, surg resection and post treatment
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Number of participants with abnormal electrocardiogram (ECG) findings
Prazo: Screening and unscheduled
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ECG was performed at screening and at unscheduled visits.
Participants with abnormal clinically significant and abnormal not clinically significant ECG findings was reported.
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Screening and unscheduled
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Number of participants with change from Baseline in echocardiogram (ECHO) or Multi-gated angiogram (MUGA) results at any post Baseline visit
Prazo: Screening, Week 8, 16, 24, post treatment
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For ECHO and MUGA scans, the left ventricular ejection fraction (percent) was summarized for each scheduled assessment.
Absolute change from Baseline was summarized according to the following categories: any increase, 0 to less than 20 percent decrease, >=20 percent decrease or >=20 percent decrease and below the lower limit of normal (LLN).
Baseline was the most recent ECOG evaluation prior to the first dose of lapatinib.
Change from Baseline was calculated as the value at the post treatment minus Baseline value.
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Screening, Week 8, 16, 24, post treatment
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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.
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 (Real)
11 de abril de 2005
Conclusão Primária (Real)
1 de novembro de 2006
Conclusão do estudo (Real)
1 de novembro de 2006
Datas de inscrição no estudo
Enviado pela primeira vez
25 de maio de 2005
Enviado pela primeira vez que atendeu aos critérios de CQ
25 de maio de 2005
Primeira postagem (Estimativa)
26 de maio de 2005
Atualizações de registro de estudo
Última Atualização Postada (Real)
31 de maio de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
27 de maio de 2017
Última verificação
1 de maio de 2017
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças de pele
- Neoplasias
- Neoplasias por local
- Doenças da mama
- Neoplasias da Mama
- Neoplasias Inflamatórias da Mama
- Mecanismos Moleculares de Ação Farmacológica
- Inibidores Enzimáticos
- Agentes Antineoplásicos
- Moduladores de Tubulina
- Agentes Antimitóticos
- Moduladores de Mitose
- Agentes Antineoplásicos Fitogênicos
- Inibidores de proteína quinase
- Paclitaxel
- Lapatinibe
Outros números de identificação do estudo
- EGF102580
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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Amsterdam UMC, location VUmcVitrOmics BVRescindidoTumores Sólidos Avançados | Metástase | InoperávelHolanda
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Shandong UniversityThe Affiliated Hospital of Qingdao University; Qianfoshan Hospital; The Second...Recrutamento