A Study of LY3009120 in Participants With Advanced Cancer or Cancer That Has Spread to Other Parts of Their Body
20 de dezembro de 2019 atualizado por: Eli Lilly and Company
A Phase 1 Study of LY3009120 in Patients With Advanced or Metastatic Cancer
The main purpose of this study is to see how safe the investigational drug known as LY3009120 is and whether it will work to help people with advanced cancer or cancer that has spread to other parts of the body.
Visão geral do estudo
Status
Rescindido
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
51
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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Nedlands, Austrália, 6009
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Barcelona, Espanha, 08035
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Arizona
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Scottsdale, Arizona, Estados Unidos, 85258
- Pinnacle Oncology Hematology
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
- Massachusetts General Hospital
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Texas
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Houston, Texas, Estados Unidos, 77030
- University of Texas MD Anderson Cancer Center
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Villejuif, França, 94805
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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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:
- Advanced or metastatic cancer
- Other available therapies have failed to cure the cancer
- The cancer that has no proven effective therapy
- The cancer can be biopsied (depending on the tumor type and/or the dose of drug received, tumor biopsies may be required)
- Able to swallow capsules
Exclusion Criteria:
- Have active cancer in the brain or spinal cord
- Have an active infection of any kind (fungal, viral, or bacterial)
- Have a cancer of the blood
- Are pregnant or breastfeeding
- Have some types of eye problems or impairments
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 de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Cohort 1 Dose Escalation
LY3009120 50 mg given orally twice daily every 12 hours for a 28-day cycle.
Participants may continue to receive study drug until discontinuation criteria are met.
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Administered orally.
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Experimental: Cohort 2 Dose Escalation
LY3009120 100 mg given orally twice daily every 12 hours for a 28-day cycle.
Participants may continue to receive study drug until discontinuation criteria are met.
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Administered orally.
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Experimental: Cohort 3 Dose Escalation
LY3009120 200 mg given orally twice daily every 12 hours for a 28-day cycle.
Participants may continue to receive study drug until discontinuation criteria are met.
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Administered orally.
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Experimental: Cohort 4 Dose Escalation
LY3009120 400 mg given orally twice daily every 12 hours for a 28-day cycle.
Participants may continue to receive study drug until discontinuation criteria are met
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Administered orally.
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Experimental: Cohort 5 Dose Escalation
LY3009120 500 mg given orally twice daily every 12 hours for a 28-day cycle.
Participants may continue to receive study drug until discontinuation criteria are met
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Administered orally.
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Experimental: Cohort 6 Dose Escalation
LY3009120 300 mg given orally twice daily every 12 hours for a 28-day cycle.
Participants may continue to receive study drug until discontinuation criteria are met
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Administered orally.
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Experimental: Cohort A Dose Confirmation
LY3009120 300 mg given orally twice daily every 12 hours for a 28-day cycle.
Participants may continue to receive study drug until discontinuation criteria are met.
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Administered orally.
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Experimental: Cohort B Dose Confirmation
LY3009120 300 mg given orally twice daily every 12 hours for a 28-day cycle.
Participants may continue to receive study drug until discontinuation criteria are met.
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Administered orally.
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Experimental: Cohort C Dose Confirmation
LY3009120 300 mg given orally twice daily every 12 hours for a 28-day cycle.
Participants may continue to receive study drug until discontinuation criteria are met.
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Administered orally.
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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) of LY3009120
Prazo: Cycle 1 (28 Days)
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Maximum tolerated dose for the recommended Phase 2 dose (RP2D) of LY3009120 that might be safely administered to participants with advanced and/or metastatic cancer.
Dose-limiting toxicity (DLT) is defined as an adverse event (AE) during Cycle 1 (28 days) that was possibly related to the study drug and met 1 of the following criteria: According to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0: ≥Grade 3 non-hematological toxicity except nausea/vomiting, diarrhea, or constipation that can be controlled with appropriate care; Grade 3 elevations of ALT and/or AST lasting fewer than 8 days (without evidence of other hepatic injury); Grade 3 rash that resolves or improves to a Grade 2 or less within 7 days; CTCAE Grade 4 hematological toxicity of >5 days duration; Grade 4 thrombocytopenia of any duration; Grade 3 thrombocytopenia with bleeding; Grade 3 febrile neutropenia.
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Cycle 1 (28 Days)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Number of Participants With Tumor Response
Prazo: Baseline through progressive disease (Up to 7.36 months)
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Number of participants with tumor response using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
CR is defined as disappearance of all target lesions.
Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm).
PR is defined as at least a 30% decrease in the sum of diameter of target lesions.
SD which is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.
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Baseline through progressive disease (Up to 7.36 months)
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Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 1
Prazo: Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10 hours (h) post-dose
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PK: Maximum concentration of LY3009120 after a single oral dose Cycle 1 Day 1.
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Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10 hours (h) post-dose
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Pharmacokinetics (PK): Maximum Concentration (Cmax) at Steady State of LY3009120 Cycle 1 Day 15
Prazo: Cycle 1 Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
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PK: Maximum concentration of LY3009120 during a twice daily dosing interval at steady state, Cycle 1 Day 15.
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Cycle 1 Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
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Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 28
Prazo: Cycle 1 Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
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PK: Maximum concentration of LY3009120 during a twice daily dosing interval at steady state, Cycle 1 Day 28.
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Cycle 1 Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
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Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of LY3009120 Cycle 1 Day 1
Prazo: Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
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PK: area under the concentration versus time curve [0-∞] of LY3009120 after a single oral dose Cycle 1 Day1.
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Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
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Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the End of Dosing Interval at Steady State (AUC[0-τ]) of LY3009120 Cycle 1 Day 15
Prazo: Cycle 1 Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
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PK: area under the concentration versus time curve from time 0 to the end of the twice daily dosing interval at steady state [AUC0-τ].
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Cycle 1 Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
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Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the End of Dosing Interval at Steady State (AUC[0-τ]) of LY3009120 Cycle 1 Day 28
Prazo: Cycle 1 Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
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PK: area under the concentration versus time curve from time 0 to the end of the twice daily dosing interval at steady state AUC[0-τ].
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Cycle 1 Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Call 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST, Eli Lilly and Company
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)
26 de novembro de 2013
Conclusão Primária (Real)
7 de abril de 2017
Conclusão do estudo (Real)
5 de outubro de 2018
Datas de inscrição no estudo
Enviado pela primeira vez
12 de dezembro de 2013
Enviado pela primeira vez que atendeu aos critérios de CQ
17 de dezembro de 2013
Primeira postagem (Estimativa)
18 de dezembro de 2013
Atualizações de registro de estudo
Última Atualização Postada (Real)
27 de dezembro de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
20 de dezembro de 2019
Última verificação
1 de dezembro de 2019
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças do aparelho digestivo
- Processos Patológicos
- Doenças Respiratórias
- Doenças pulmonares
- Neoplasias por local
- Neoplasias gastrointestinais
- Neoplasias do Aparelho Digestivo
- Doenças Gastrointestinais
- Neoplasias do Trato Respiratório
- Neoplasias Torácicas
- Carcinoma Broncogênico
- Neoplasias Brônquicas
- Doenças do cólon
- Doenças Intestinais
- Neoplasias Intestinais
- Doenças retais
- Processos Neoplásicos
- Neoplasias Pulmonares
- Neoplasias
- Carcinoma pulmonar de células não pequenas
- Neoplasias Colorretais
- Neoplasia Metástase
Outros números de identificação do estudo
- 13873 (Outro identificador: Stanford IRB)
- I6X-MC-JBDA (Outro identificador: Eli Lilly and Company)
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 .