Evaluation of Enzastaurin in the Treatment of Persistent or Recurrent Ovarian or Primary Peritoneal Cancer
24 de novembro de 2020 atualizado por: Eli Lilly and Company
A Phase II Evaluation of Enzastaurin in the Treatment of Persistent or Recurrent Ovarian or Primary Peritoneal Carcinoma
The purpose is to assess the efficacy and toxicity of the study agent, enzastaurin, in participants with recurrent or persistent ovarian cancer.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
28
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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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19103
- Gynecologic Oncology Group 215-854-0770
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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
Fêmea
Descrição
Inclusion Criteria:
- Participants must have recurrent or persistent epithelial ovarian or primary peritoneal carcinoma.
- All participants must have measurable disease.
- Participants must have at least one "target lesion" to be used to assess response on this protocol.
- Participants must not be eligible for a higher priority GOG protocol, if one exists.
- Participants who have received one prior regimen must have a GOG Performance Status of 0, 1, or 2. Participants who have received two prior regimens must have a GOG Performance Status of 0 or 1.
- Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration. Continuation of hormone replacement therapy is permitted.
- Any other prior therapy directed at the malignant tumor, including immunologic agents, must be discontinued at least four weeks prior to registration.
- Participants must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound.
- Participants must NOT have received any non-cytotoxic therapy for management of recurrent or persistent disease.
- Participants of child-bearing potential must have a negative serum pregnancy test prior to study entry and be practicing an effective form of contraception (for example, intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after discontinuation of study treatment.
Exclusion Criteria:
- Participants with previous enzastaurin treatment.
- Participants who have received radiation to more than 25% of marrow-bearing areas
- Participants with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy.
- Participants who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
- Participants who are unable to discontinue use of carbamazepine, phenobarbital, and phenytoin (refer to Concomitant Medications for a discussion of enzyme inducing anti-epileptic drugs [EIAEDs]).
- Participants who are receiving concurrent administration of any other systemic anticancer therapy except for a biphosphonate if patient has bony metastases.
- Participants who have received prior therapy with non-cytotoxic agents (i.e. bevacizumab).
- Participants with serious concomitant systemic disorders (for example, active infection or abnormal electrocardiogram (ECG) indicative of cardiac disease) that, in the opinion of the investigator, would compromise the safety of the patient and his/her ability to complete the study.
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 sequencial
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: UMA
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1125 mg loading dose then 500 mg, oral, daily, until progressive disease
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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Progression-free Survival for at Least 6 Months (PFS-6)
Prazo: Baseline through 6 months
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Data presented are the percentage of participants without progressive disease (PD) or death from any cause 6 months after registration.
PD was a 25% increase in the sum of products of all measurable lesions (or 2 largest lesions if too numerous) over the smallest sum observed (over baseline if no decrease) or clear worsening of any evaluable disease, or appearance of any new lesion/site, or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
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Baseline through 6 months
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Number of Participants With Adverse Events and Severe Adverse Events
Prazo: Baseline through end of study (Up to 45 months)
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Data presented are the number of participants who experienced 1 or more adverse events (AEs) (all causalities and drug-related) and serious AEs (SAEs).
A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this record.
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Baseline through end of study (Up to 45 months)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Duration of Progression-Free Survival
Prazo: Baseline to disease progression (Up to 38 months)
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PFS is defined as the rate of PFS from the date of diagnosis to the first date of objectively determined progressive disease (based on radiological assessment) or death from any cause.
It is assumed that PFS follows an exponential distribution.
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Baseline to disease progression (Up to 38 months)
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Prognostic Factors: Platinum Sensitivity
Prazo: Baseline
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Participants who had disease progression within 6 months of ending their last regimen of platinum therapy were considered platinum resistant.
Participants who had disease progression between 6 and 12 months of ending their last platinum regimen were considered platinum sensitive.
Participants who had disease progression beyond 12 months of ending their last platinum regimen were also considered platinum sensitive.
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Baseline
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Prognostic Factors: Performance Status
Prazo: Baseline
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Performance Status 0 = Fully active, able to carry on all pre-disease performance without restriction Performance Status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work.
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Baseline
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Overall Survival
Prazo: Baseline through end of study (Up to 45 months)
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Overall survival (OS) time is defined as the time from the date of diagnosis to the date of death from any cause.
For participants who are still alive at the time of analysis, survival time will be censored at the last contact date.
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Baseline through end of study (Up to 45 months)
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Diretor de estudo: Lydia Usha, Gynecologic Oncology Group
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 janeiro de 2007
Conclusão Primária (Real)
1 de maio de 2008
Conclusão do estudo (Real)
1 de dezembro de 2014
Datas de inscrição no estudo
Enviado pela primeira vez
8 de janeiro de 2007
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de janeiro de 2007
Primeira postagem (Estimativa)
11 de janeiro de 2007
Atualizações de registro de estudo
Última Atualização Postada (Real)
19 de dezembro de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
24 de novembro de 2020
Última verificação
1 de novembro de 2020
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 10738
- H6Q-MC-S025 (Outro identificador: Eli Lilly and Company)
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