- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01416389
A Study of LY2523355 in Participants With Breast Cancer
A Randomized Phase 2 Study of LY2523355 Versus Ixabepilone in Patients With Metastatic or Locally Recurrent Breast Cancer Who Have Received Prior Taxane Therapy
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
-
-
Florida
-
Fort Myers, Florida, Estados Unidos, 33916
- 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.
-
Pensacola, Florida, Estados Unidos, 32503
- 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.
-
-
Georgia
-
Gainesville, Georgia, Estados Unidos, 30501
- 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.
-
-
Maryland
-
Bethesda, Maryland, Estados Unidos, 20817
- 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.
-
-
Ohio
-
Cincinnati, Ohio, Estados Unidos, 45219
- 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.
-
Toledo, Ohio, Estados Unidos, 43623
- 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.
-
-
South Carolina
-
Columbia, South Carolina, Estados Unidos, 29210
- 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.
-
Spartanburg, South Carolina, Estados Unidos, 29303
- 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.
-
-
Tennessee
-
Chattanooga, Tennessee, Estados Unidos, 37404
- 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.
-
Nashville, Tennessee, Estados Unidos, 37203
- 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.
-
-
Texas
-
Fort Worth, Texas, Estados Unidos, 76104
- 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.
-
-
Virginia
-
Richmond, Virginia, Estados Unidos, 23230
- 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.
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Have histologic or cytologic diagnosis of metastatic or locally recurrent breast cancer that is not amenable to therapy given with curative intent.
- Have measurable disease defined by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 guidelines.
- Have received 2 or more prior standard cytotoxic chemotherapy regimens for metastatic breast cancer and be, in the opinion of the investigator, an appropriate candidate for experimental therapy. Regimens received in the neoadjuvant or adjuvant setting are not counted as prior regimens.
- Have received a prior taxane in the neoadjuvant, adjuvant, or metastatic setting.
- Have recovered from the acute effects of prior chemotherapy, hormonal therapy, and radiation prior to study enrollment.
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
- Have adequate organ function.
Exclusion Criteria:
- Have Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or greater (moderate or worse) peripheral neuropathy
- Have a second primary malignancy.
- Have symptomatic, untreated, or uncontrolled central nervous system metastases.
- Have received autologous stem cell transplant following high-dose chemotherapy.
- Have serious preexisting medical conditions that in the opinion of the investigator would preclude participation in this study.
- Have active symptomatic fungal, bacterial, and/or known viral infection including active human immunodeficiency virus (HIV) or viral hepatitis.
- Have previously received LY2523355 in another study investigating this agent or therapy with ixabepilone or an ixabepilone-containing regimen.
- Have a history of radiation therapy involving more than 25 percent of the bone marrow.
- Have a Fridericia corrected QT (QTcF) interval of >470 milliseconds (msec) on screening electrocardiogram (ECG).
- Have QRS widening of >120 msec on screening ECG.
- Cannot change or stop taking a strong Cytochrome P450 3A4 (CYP3A4) inhibitor or CYP3A4 inducer per the ixabepilone label.
- Have hypersensitivity to drugs formulated with Cremophor® EL per the ixabepilone label.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: LY2523355 + pegfilgrastim or filgrastim
LY2523355: Five milligrams per meter squared per day (mg/m^2/day) (dosage determined by calculating participant's body surface area) administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles.
Pegfilgrastim or Filgrastim: Dosage is determined by standard of care and is administered intravenously on Day 4 of 21-day Cycle for 2 Cycles.
If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.
|
Administered intravenously as a one hour infusion
Administered intravenously
Administered intravenously
|
Comparador Ativo: ixabepilone
Forty milligrams per meter squared per day (mg/m^2/day) (dosage determined by calculating participant's body surface area) administered intravenously as a 3-hour infusion on Day 1 of a 21-day Cycle for 2 Cycles.
If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.
|
Administered intravenously
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Change in Tumor Size (CTS) From Baseline to the End of Cycle 2
Prazo: Baseline up to end of Cycle 2 (Day 42)
|
The log ratio of tumor size at Cycle 2 to tumor size at baseline is calculated for each participant, where the tumor size is the sum of the target lesion measurements at each assessment.
|
Baseline up to end of Cycle 2 (Day 42)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Percentage of Participants Achieving an Overall Response (Overall Response Rate)
Prazo: Baseline to measured progressive disease or date of death from any cause (up to 423 days)
|
Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1) guidelines.
CR is a disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm).
PR is an at least 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter.
Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with measurable disease, multiplied by 100.
|
Baseline to measured progressive disease or date of death from any cause (up to 423 days)
|
Progression-free Survival (PFS)
Prazo: Baseline to measured progressive disease or date of death from any cause (up to 423 days)
|
Progression-free survival (PFS) is the time from the date of randomization to the first date of progressive disease (PD) or death due to any cause, whichever occurs first.
PD is as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1) guidelines, and is defined as an increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if that was the smallest on study).
In addition, the sum must have demonstrated an absolute increase of at least 5 millimeter (mm) (the appearance of 1 or more new lesions was considered progression).
Kaplan-Meier analysis was performed on the observed distribution of PFS.
Participants were censored from analysis for the following reasons: lack of disease assessment, lost to follow-up, and further anticancer therapy started.
Median PFS is presented.
|
Baseline to measured progressive disease or date of death from any cause (up to 423 days)
|
Percentage of Participants Achieving a Clinical Benefit (Clinical Benefit Rate)
Prazo: Baseline to measured progressive disease or date of death from any cause (up to 423 days)
|
Clinical benefit rate is the proportion of participants who achieve a best response of complete response (CR), partial response (PR), or stable disease (SD) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1) guidelines. CR is a disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). PR is an at least 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. SD is neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as progressive disease, taking as reference the smallest sum diameter since treatment started. Clinical benefit rate is calculated as a total number of participants with CR, PR, or SD divided by the total number of participants with measurable disease, multiplied by 100. |
Baseline to measured progressive disease or date of death from any cause (up to 423 days)
|
Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LY2523355
Prazo: Cycle 1: Day 1 and Day 3
|
Cmax is the maximum plasma concentration of LY2523355 after a 1-hour intravenous infusion of LY2523355 on Day 1 and Day 3 of Cycle 1.
|
Cycle 1: Day 1 and Day 3
|
Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LSN2546307
Prazo: Cycle 1: Day 1 and Day 3
|
Cmax is the maximum plasma concentration of LSN2546307 (metabolite) after a 1-hour intravenous infusion of LY2523355 on Day 1 and Day 3 of Cycle 1.
|
Cycle 1: Day 1 and Day 3
|
Pharmacokinetics, Intracycle Accumulation Ration (Ra) of LY2523355
Prazo: Cycle 1: Day 1 and Day 3
|
The intracycle accumulation ratio (Ra) is defined as the LY2523355 Cmax on Day 3 of Cycle 1 to the LY2523355 Cmax on Day 1 of Cycle 1 after a 1-hour intravenous infusion of LY2523355 on Day 1 and Day 3 of Cycle 1.
|
Cycle 1: Day 1 and Day 3
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Percentage of Deaths on Study Through the Follow-up Period
Prazo: Baseline through end of treatment follow-up (up to 423 days)
|
The percentage of participants who died through the follow-up period of the study; the cause of death was not captured. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. |
Baseline through end of treatment follow-up (up to 423 days)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hour, EST), Eli Lilly and Company
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 12847
- I1Y-MC-JFBE (Outro identificador: Eli Lilly and Company)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CSR
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 Câncer de Mama Metastático
-
Turku University HospitalLounais-Suomen SyöpäyhdistysAinda não está recrutandoSobrevivente de cancerFinlândia
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)RetiradoSobrevivente de cancerEstados Unidos
-
University of Alabama at BirminghamNational Cancer Institute (NCI); Auburn UniversityConcluído
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI)ConcluídoSobrevivente de cancerEstados Unidos
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)ConcluídoSobrevivente de cancerEstados Unidos, Guam
-
Wake Forest University Health SciencesNational Cancer Institute (NCI); National Institute of Mental Health (NIMH)ConcluídoSobrevivente de cancerEstados Unidos
-
Masonic Cancer Center, University of MinnesotaConcluídoSobrevivente de cancerEstados Unidos
-
Abramson Cancer Center of the University of PennsylvaniaConcluídoPlano de cuidados de sobrevivência LIVESTRONG: coleta contínua de dados e pesquisa de acompanhamentoPaciente com cancerEstados Unidos
-
University of New MexicoNew Mexico State University; University of New Mexico Cancer CenterConcluído
-
Ohio State University Comprehensive Cancer CenterConcluídoSobrevivente de cancerEstados Unidos
Ensaios clínicos em LY2523355
-
Kyowa Kirin Co., Ltd.Concluído
-
Eli Lilly and CompanyRescindido
-
Eli Lilly and CompanyConcluídoCâncer de intestino | Câncer colorretal | Câncer de esôfago | Cancro do ovário | Câncer de próstata | Câncer de Pulmão de Células Não Pequenas | Câncer de Cabeça e PescoçoEstados Unidos
-
Eli Lilly and CompanyConcluídoCâncer metastático | Câncer AvançadoEstados Unidos
-
Eli Lilly and CompanyConcluídoCâncer de Pulmão de Pequenas CélulasEstados Unidos, Republica da Coréia, Romênia