- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00738751
Phase I Study of LBH589 & Erlotinib for Advanced Aerodigestive Tract Cancers
3 de fevereiro de 2015 atualizado por: H. Lee Moffitt Cancer Center and Research Institute
Phase I Study of LBH589 in Combination With Erlotinib for Advanced Aerodigestive Tract Cancers (CLBH5889CUS11T)
The main purpose of the study is to:
- Determine the safety and tolerability of erlotinib and LBH589B.
- Establish a recommended phase II expansion dosing of LBH589B and erlotinib in patients with advanced aerodigestive tract cancers.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
44
Estágio
- 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
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Florida
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Tampa, Florida, Estados Unidos, 33612
- H. Lee Moffitt Cancer Center & Research Institute
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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:
- Histologically or cytologically documented diagnosis of advanced/metastatic NSCLC or Head and Neck cancer.
- Male or female patients aged ≥ 18 years old
- Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
- Have progressive and measurable disease that can be measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- Patients must have discontinued prior systemic chemotherapy by 14 days.
Patients must meet the following laboratory criteria:
- Serum albumin ≥ 3g/dL
- Aspartic transaminase (AST/SGOT) and alanine transaminase (ALT/SGPT) ≤ 2.5 x upper limit of normal (ULN)or ≤ 5.0 x ULN if the transaminase elevation is due to leukemic involvement
- Serum bilirubin ≤ 1.5 x ULN
- Serum creatinine ≤ 1.5 x ULN or 24-hour creatinine clearance ≥ 50 ml/min
- Serum potassium ≥ lower limit of normal (LLN) and ≤ ULN
- Serum phosphorous ≥ LLN
- Serum total calcium (corrected for serum albumin) or serum ionized calcium ≥ LLN
- Serum magnesium ≥ LLN
- Absolute neutrophil count (ANC) (ANC: segmented and bands) ≥ 1.5 X10^9/L
- Platelets ≥ 100 X 10^9/L
- Baseline multiple gated acquisition imaging (MUGA) or echocardiogram (ECHO) must demonstrate left ventricular ejection fraction (LVEF) ≥ the lower limit of the institutional normal
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
- Reproductive potential must be either terminated (by surgery, radiation, or menopause) or attenuated by the use of an approved contraceptive method during and for 3 to 6 months following the study.
- Patient instructed that intravenous (IV) bisphosphonates will be withheld for the first 8 weeks of LBH589 therapy due to risk of hypocalcemia.
Exclusion Criteria:
Impaired cardiac function including any one of the following:
- Screening electrocardiogram (ECG) with a corrected QT (QTc) > 450 msec confirmed by central laboratory prior to enrollment to the study
- Patients with congenital long QT syndrome
- History of sustained ventricular tachycardia
- Any history of ventricular fibrillation or torsades de pointes
- Bradycardia defined as heart rate < 50 beats per minute. Patients with a pacemaker and heart rate ≥ 50 beats per minute are eligible.
- Patients with a myocardial infarction or unstable angina within 6 months of study entry
- Congestive heart failure - New York Heart Association (NYHA) class III or IV
- Right bundle branch block and left anterior hemiblock (bifascicular block)
- Patients with a history of uncontrolled or chronic atrial fibrillation.
- Uncontrolled hypertension, blood pressure (BP) >180/110 on 3 separate occasions despite oral antihypertensive medications
- Concomitant use of drugs with a risk of causing torsades de pointes Concomitant use of CYP3A4 inhibitors
- Patients with documented central nervous system or leptomeningeal metastasis (brain metastasis) at the time of study entry. Patients with prior brain metastasis may be considered if they have completed their treatment for brain metastasis, no longer require corticosteroids, and are asymptomatic.
- Patients with unresolved diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade 1
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LBH589
- Other concurrent severe and/or uncontrolled medical conditions
- Patients who have received chemotherapy < 14 days, any investigational drug < 14 days or undergone major surgery < 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy.
- Concomitant use of any anti-cancer therapy (except erlotinib) or radiation therapy.
- Female patients who are pregnant or breast feeding or patients of reproductive potential not using two effective methods of birth control. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days of the first administration of oral LBH589
- Male patients whose sexual partners are WOCBP not using effective birth control
- Patients with known positivity for human immunodeficiency virus (HIV) or hepatitis C; baseline testing for HIV and hepatitis C is not required
- Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent
- Patients who are not willing to refrain from wearing contact lenses during study participation will be excluded.
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 |
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Experimental: Dose Escalation Followed by Expansion
Eligible participants were enrolled in a 3+3 dose-escalation design to determine the maximum tolerated dose (MTD) of twice weekly panobinostat plus daily erlotinib at 4 planned dose levels (DLs).
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Panobinostat was taken twice weekly, for 2 out of 3 weeks of each cycle.
Each cycle was defined as a 21-day period.
Four dose levels of panobinostat in combination with erlotinib were planned: 1) dose level 1 (DL1) = panobinostat 20 mg by mouth (PO) twice weekly for 2 out of 3 weeks + erlotinib 100 mg PO daily; 2) dose level 2 (DL2) = panobinostat 30 mg and erlotinib 100 mg; 3) dose level 3 (DL3) = panobinostat 30 mg and erlotinib 150 mg; and 4) dose level 4 (DL4) = panobinostat 40 mg and erlotinib 150 mg.
Doses were not escalated over the course of treatment of an individual participant.
Outros nomes:
Erlotinib was taken daily without interruption.
Each cycle was defined as a 21-day period.
Panobinostat was taken twice weekly, for 2 out of 3 weeks of each cycle.
Four dose levels of panobinostat in combination with erlotinib were planned: 1) dose level 1 (DL1) = panobinostat 20 mg by mouth (PO) twice weekly for 2 out of 3 weeks + erlotinib 100 mg PO daily; 2) dose level 2 (DL2) = panobinostat 30 mg and erlotinib 100 mg; 3) dose level 3 (DL3) = panobinostat 30 mg and erlotinib 150 mg; and 4) dose level 4 (DL4) = panobinostat 40 mg and erlotinib 150 mg.
Doses were not escalated over the course of treatment of an individual participant.
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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Maximum Tolerated Dose (MTD)
Prazo: 4 Months
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Determine safety and tolerability of erlotinib and LBH589B and establish a recommended phase II expansion dosing of LBH589B and erlotinib in patients with advanced aerodigestive tract cancers.
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4 Months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Disease Control Rate (DCR)
Prazo: Up to 48 months
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DCR: The percentage of patients with advanced or metastatic cancer who have achieved complete response (CR), partial response (PR) and stable disease (SD) to a therapeutic intervention in clinical trials of anticancer agents.
CR: is defined as disappearance of all target lesions.
PR: is defined as at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD.
SD: is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started.
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Up to 48 months
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Progression Free Survival (PFS) by Cancer Type
Prazo: Up to 48 months
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Progressive Disease (PD) is defined as at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
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Up to 48 months
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Overall Survival (OS) by Cancer Type
Prazo: Up to 48 months
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Overall survival (OS) is the duration from date of randomization to date of death from any cause.
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Up to 48 months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Jhanelle Gray, M.D., H. Lee Moffitt Cancer Center and Research Institute
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 novembro de 2008
Conclusão Primária (Real)
1 de agosto de 2013
Conclusão do estudo (Real)
1 de fevereiro de 2015
Datas de inscrição no estudo
Enviado pela primeira vez
18 de agosto de 2008
Enviado pela primeira vez que atendeu aos critérios de CQ
18 de agosto de 2008
Primeira postagem (Estimativa)
20 de agosto de 2008
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
4 de fevereiro de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
3 de fevereiro de 2015
Última verificação
1 de fevereiro de 2015
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- MCC-15461
- LBH589 (Outro identificador: Novartis)
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 Panobinostat (LBH589)
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Abdullah KutlarSecura Bio, Inc.RecrutamentoAnemia falciformeEstados Unidos
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Centre Leon BerardConcluído
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NovartisConcluídoLinfoma Cutâneo de Células T | TumoresJapão
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University of Wisconsin, MadisonNovartis PharmaceuticalsRescindidoTumores NeuroendócrinosEstados Unidos
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Duke UniversityNovartisRetirado
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Novartis PharmaceuticalsConcluídoTumores Sólidos AvançadosSuíça, Holanda, Estados Unidos, Reino Unido
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Novartis PharmaceuticalsConcluídoCâncer de próstataCanadá, Estados Unidos
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Novartis PharmaceuticalsConcluídoLeucemia Mielóide Aguda | Leucemia RefratáriaBélgica, Republica da Coréia, Peru, Alemanha, Austrália, França, Suíça, Reino Unido, Espanha, Itália, Peru, Estados Unidos
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Translational Research in OncologyRescindido