Darbepoetin Alfa and Anemia of Cancer
11 de dezembro de 2013 atualizado por: Amgen
A Randomized, Open-label, Comparative Study to Estimate the Effect of Darbepoetin Alfa on Hospital Days, Economic Outcomes, and Health-related Quality of Life in Subjects With Nonmyeloid Malignancies and Anemia of Cancer
This phase 2, multicenter, randomized, open-label, comparative study was designed to determine the effect of darbepoetin alfa on hospital days, economic outcomes, and health related quality of life (HRQOL) in anemic patients with nonmyeloid malignancies who were not receiving chemotherapy.
Participants were randomly assigned in a 4:1 allocation ratio to receive either 21 weeks of darbepoetin alfa treatment (treatment group) or 12 weeks of observation followed by up to 9 weeks of darbepoetin alfa treatment (observation group).
Visão geral do estudo
Status
Rescindido
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
287
Estágio
- Fase 2
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:
- nonmyeloid malignancies (including lymphocytic leukemias)
- anemia (hemoglobin concentration less than or equal to 11.0 g/dL) due to cancer and/or previous chemotherapy or radiotherapy
- Eastern Cooperative Oncology Group performance status of 0 to 2
- adequate liver and renal functions
- 18 years or older
Exclusion Criteria:
- history of recombinant human erythropoietin therapy, cytotoxic chemotherapy, or more than 30 Gy radiotherapy to the whole pelvis within 4 weeks before screening
- acute myelogenous leukemia, chronic myelogenous leukemia, or myelodysplastic syndrome
- known hematologic disorders that could cause anemia
- inflammatory or cardiac disorders
- previous positive antibody response to any erythropoietic agent
- history of pure red cell aplasia
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: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Outro: Observational Group
Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period).
No darbepoetin alfa was administered to the observation group during this period.
Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participants hemoglobin concentration was less than or equal to 11.0 g/dL.
The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
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Administered subcutaneously.
Outros nomes:
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Comparador Ativo: 21 week treatment group
Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks.
The dose of darbepoetin alfa could be increased at week 7 (to 5.0 μg/kg once every 2 weeks) or at week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at week 7.
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Administered subcutaneously.
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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Number of Participants Hospitalized During the Test Period
Prazo: Weeks 1- 12
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Number of participants hospitalized during Weeks 1-12 as self-reported in the Health Care Utilization portion of the Subject Outcome Questionaire.
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Weeks 1- 12
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Days of Hospitalization During the Test Period
Prazo: Weeks 1-12
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Number of days hospitalized during Weeks 1-12 as self-reported in the Health Care Utilization portion of the Subject Outcome Questionaire; participants who were not hospitalized had a value of 0 days.
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Weeks 1-12
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Number of Hospitalizations During the Test Period
Prazo: Weeks 1-12
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Number of times participants were hospitalized as self-reported in the Health Care Utilization portion of the Subject Outcome Questionaire during Weeks 1-12
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Weeks 1-12
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Total Hospital Costs During the Test Period
Prazo: Weeks 1-12
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The hospital bill database was used to determine the mean total hospital cost per participant during the test period.
Participants who were not hospitalized had a cost of $0 imputed.
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Weeks 1-12
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Change in Functional Assessment of Cancer Therapy (FACT)-Fatigue Score at Week 13
Prazo: Baseline (Week 1) and Week 13
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The FACT-Fatigue scale comprises 13 questions evaluating the impact of anemia on cancer patients with various tumor types receiving chemotherapy.
Fatigue scores range from 0 to 52, with a higher score indicating less fatigue.
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Baseline (Week 1) and Week 13
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Hemoglobin Response During the Test Period
Prazo: Weeks 1-12
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The number of participants achieving a hemoglobin response, defined as an increase in hemoglobin from baseline of ≥ 2.0 g/dL in the absence of red blood cell (RBC) transfusions during the preceding 28 days.
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Weeks 1-12
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Hematopoietic Response During the Test Period
Prazo: Weeks 1-12
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The number of participants achieving a hematopoietic response, defined as an increase in hemoglobin from baseline of ≥ 2.0 g/dL or a concentration ≥ 12.0 g/dL both in the absence of red blood cell (RBC) transfusions during the preceding 28 days.
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Weeks 1-12
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Change From Baseline in Hemoglobin Level
Prazo: Baseline (Week 1) and Week 13
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The difference between hemoglobin concentrations after 12 weeks of treatment and the Baseline hemoglobin concentration value (Study Day 1 sample prior to first dose of darbepoetin alfa).
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Baseline (Week 1) and Week 13
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Number of Participants With Red Blood Cell (RBC) Transfusions During the Test Period
Prazo: Weeks 1-12
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Number of participants with at least one RBC transfusion during Weeks 1 to 12.
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Weeks 1-12
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Number of Units of Red Blood Cells Transfused During the Test Period
Prazo: Weeks 1-12
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The average number of standard units of red blood cells transfused during Weeks 1 to 12.
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Weeks 1-12
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Number of Days of Red Blood Cell Transfusions During the Test Period
Prazo: Weeks 1-12
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The number of days when at least one red blood cell transfusion was administered during Weeks 1 to 12.
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Weeks 1-12
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Number of Participants With Red Blood Cell (RBC) Transfusions During Weeks 5-12
Prazo: Weeks 5-12
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The number of participants with at least one RBC transfusion during weeks 5 to 12.
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Weeks 5-12
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Number of Units of Red Blood Cells Transfused During Weeks 5-12
Prazo: Weeks 5-12
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The number of standard units of RBCs transfused during Weeks 5 to 12.
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Weeks 5-12
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Number of Days of Red Blood Cell Transfusions During Weeks 5-12
Prazo: Weeks 5-12
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The number of days when at least one RBC transfusion was administered during Weeks 5 to 12.
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Weeks 5-12
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
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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 maio de 2002
Conclusão Primária (Real)
1 de janeiro de 2004
Conclusão do estudo (Real)
1 de junho de 2004
Datas de inscrição no estudo
Enviado pela primeira vez
1 de outubro de 2009
Enviado pela primeira vez que atendeu aos critérios de CQ
1 de outubro de 2009
Primeira postagem (Estimativa)
2 de outubro de 2009
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
29 de janeiro de 2014
Última atualização enviada que atendeu aos critérios de controle de qualidade
11 de dezembro de 2013
Última verificação
1 de dezembro de 2013
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 20000219
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