A Study On An Immunostimulant Antibody In Combination With Chemotherapy For Advanced Cancer Of The Pancreas
26 de novembro de 2013 atualizado por: Hoffmann-La Roche
A Phase 1 Dose Escalation Open Label Study Of CP-870,893 In Combination With Gemcitabine In Patients With Chemotherapy-Naïve Surgically Incurable Pancreatic Cancer
This study aims to seek evidence that activation of certain cells of the immune system will be safe and well tolerated in combination with cytotoxic chemotherapy.
Preliminary evidence of clinical anti-tumor activity will be sought.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
22
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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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- Pfizer Investigational Site
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Pfizer Investigational Site
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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:
- 1st-line surgically incurable cancer of the pancreas
- ECOG(Eastern Cooperative Oncology Group) performance status 0-1
Exclusion Criteria:
- Previous systemic therapy for pancreas cancer
- History of cancer-associated blood clots
- History of autoimmune disease
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: único braço
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CP-870,893 intravenous administration [IV] on day 3 of 4-week cycles
gemcitabine 1000 mg/m^2 intravenous administration [IV] q week [wk]x3 of 4-week cycles
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs)
Prazo: Baseline up to Cycle 1 / Day 28
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Any of the following during first cycle of treatment and attributable to CP-870893: afebrile Grade (Gr) 4 neutropenia (absolute neutrophil count [ANC] <500 cells/mm^3) ≥7 days or Gr 3 or 4 neutropenia associated with fever (1 oral temperature >38.5 degrees Celsius (C) or 3 oral temperatures >38.0 degrees C in a 24-hour period); Gr 4 thrombocytopenia or Gr 3 thrombocytopenia associated with bleeding; Gr 4 lymphopenia, if coupled with clinical consequence (such as, opportunistic infection) or any other Gr 3 hematological adverse events; ≥Gr 3 non-hematologic toxicities (except alopecia). |
Baseline up to Cycle 1 / Day 28
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage of Participants With Objective Tumor Response According to Response Evaluation Criteria in Solid Tumors (RECIST)
Prazo: At the end of every even-numbered cycle (cycle=28 days) up to a maximum of 12 cycles and 4 to 6 weeks following initial documentation of response
|
Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST.
Confirmed CR defined as disappearance of all target lesions.
Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST.
Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.
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At the end of every even-numbered cycle (cycle=28 days) up to a maximum of 12 cycles and 4 to 6 weeks following initial documentation of response
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Overall Survival (OS)
Prazo: Baseline, assessed monthly until death or 7.5 months after last participant was enrolled (up to January 2011)
|
OS is time from baseline to death from any cause.
Participants last known to be alive were censored at the date of last contact.
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Baseline, assessed monthly until death or 7.5 months after last participant was enrolled (up to January 2011)
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Progression Free Survival (PFS)
Prazo: Baseline, assessed monthly until death or 7.5 months after last participant was enrolled (up to January 2011)
|
PFS is time from baseline to first progression (Prog) or death from any cause.
Participants last known to be alive, had not started a new (non-protocol) cancer treatment, were Prog-free, and who had a baseline and ≥1 on-study disease assessment were censored at date of last objective disease assessment that verified lack of Prog.
Participants who were off treatment prior to Prog and who had no on-study disease assessment were also censored.
Prog: ≥20% increase in sum of longest dimension (LD) of target lesions from smallest sum LD recorded since treatment start or appearance of ≥1 new lesions.
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Baseline, assessed monthly until death or 7.5 months after last participant was enrolled (up to January 2011)
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Time to Progression
Prazo: Monthly until death or 7.5 months after last participant was enrolled (up to January 2011)
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Disease progression defined as ≥20% increase in sum LD of target lesions from smallest sum LD recorded since treatment start or appearance of ≥1 new lesions.
Criteria for progression also included unequivocal progression of existing nontarget lesions.
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Monthly until death or 7.5 months after last participant was enrolled (up to January 2011)
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Maximum Serum Concentration (Cmax)
Prazo: Cycle 1 / Day 3 pre-dose, 5 minutes after End of Infusion (EOI), and 2, 6, and 24 hours after EOI and pre-dose on Day 3 of every subsequent cycle up to a maximum of 12 cycles
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Cycle 1 / Day 3 pre-dose, 5 minutes after End of Infusion (EOI), and 2, 6, and 24 hours after EOI and pre-dose on Day 3 of every subsequent cycle up to a maximum of 12 cycles
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Prazo: Cycle 1 / Day 3 pre-dose, 5 minutes after EOI, and 2, 6, and 24 hours after EOI and pre-dose on Day 3 of every subsequent cycle up to a maximum of 12 cycles
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Area under the serum concentration time-curve from time zero to the last measured concentration.
AUClast analyzed using a noncompartmental approach to estimate individual participant values.
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Cycle 1 / Day 3 pre-dose, 5 minutes after EOI, and 2, 6, and 24 hours after EOI and pre-dose on Day 3 of every subsequent cycle up to a maximum of 12 cycles
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Change (Pre-dose to Post-dose) in Plasma Cytokine Concentrations: Pre-dose Concentration (CYTO0), Maximum Concentration (CTYOMAX)
Prazo: Cycle 1 / Day 1 prior to gemcitabine infusion (0 hour), 5 minutes after EOI and 2, 4, 6, and 24 hours after EOI; Cycle 1 / Day 3 prior to CP-970893 infusion (0 hour), 5 minutes after EOI, and 2, 4, 6, and 24 hours after EOI
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An increase in values indicates greater cytokine release from cells targeted by the antibody and may be associated with an infusion reaction.
Change calculated as mean of pre-dose and maximum post-dose values.
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Cycle 1 / Day 1 prior to gemcitabine infusion (0 hour), 5 minutes after EOI and 2, 4, 6, and 24 hours after EOI; Cycle 1 / Day 3 prior to CP-970893 infusion (0 hour), 5 minutes after EOI, and 2, 4, 6, and 24 hours after EOI
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Change (Pre-dose to Post-dose) in Plasma Cytokine Concentrations: Time of Maximum Concentration (TCYTOMAX)
Prazo: Cycle 1 / Day 1 prior to gemcitabine infusion (0 hour), 5 minutes after EOI and 2, 4, 6, and 24 hours after EOI; Cycle 1 / Day 3 prior to CP-970893 infusion (0 hour), 5 minutes after EOI, and 2, 4, 6, and 24 hours after EOI
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An increase in values indicates greater cytokine release from cells targeted by the antibody and may be associated with an infusion reaction.
Change calculated as mean of pre-dose and maximum post-dose values.
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Cycle 1 / Day 1 prior to gemcitabine infusion (0 hour), 5 minutes after EOI and 2, 4, 6, and 24 hours after EOI; Cycle 1 / Day 3 prior to CP-970893 infusion (0 hour), 5 minutes after EOI, and 2, 4, 6, and 24 hours after EOI
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Total and Neutralizing Human Antihuman Antibody (HAHA) Titer
Prazo: Prior to infusion of CP-870893 on Day 3 of every cycle up to a maximum of 12 cycles
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HAHA assessed as an indicator of immunogenicity to CP-870893.
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Prior to infusion of CP-870893 on Day 3 of every cycle up to a maximum of 12 cycles
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Change (Pre-dose to Post-dose) in Bone Marrow Derived Cells (B Cell) Surface Markers: CD54, CD23, CD40, CD86, and Human Leukocyte Antigen (HLA-DR)
Prazo: Cycle 1 / Day 1 and Cycle 1 / Day 8 prior to gemcitabine infusion and 6 and 24 hours after EOI; Cycle 1 / Day 3 prior to CP-870893 infusion and 6, 24, and 48 hours after EOI
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Assess the ability of PF-870893 to activate B-cells and HLA-DR which are involved in the production of antibodies.
Change calculated as mean of pre-dose and post-dose values.
Positive values indicate greater presence of cells associated with antibody production.
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Cycle 1 / Day 1 and Cycle 1 / Day 8 prior to gemcitabine infusion and 6 and 24 hours after EOI; Cycle 1 / Day 3 prior to CP-870893 infusion and 6, 24, and 48 hours after EOI
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18-fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) Imaging (MTD Expansion Cohort)
Prazo: Baseline, Week 2, Week 8, and Single Time Point (STP) PET for all PET scans after Week 8
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FDG PET assessment to characterize and monitor tumors before and after study treatment; measured as a standardized uptake value (SUV).
A reduction in SUV from baseline for at least 1 tumor may indicate a positive metabolic response to treatment.
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Baseline, Week 2, Week 8, and Single Time Point (STP) PET for all PET scans after Week 8
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Carbohydrate Antigen 19-9 (CA 19-9)
Prazo: At the end of every even-numbered cycle (cycle=28 days) and 4 to 6 weeks following initial documentation of response
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CA 19-9 or sialylated Lewis (a) antigen (a tumor marker).
Values higher than 37 units per milliliter (U/ml) considered abnormal; higher values usually indicate greater presence of disease.
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At the end of every even-numbered cycle (cycle=28 days) and 4 to 6 weeks following initial documentation of response
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Recommended Phase 2 Dose (RP2D) of CP-870893 in Participants With Advanced Pancreas Cancer
Prazo: Baseline up to time of determination of maximum tolerated dose (MTD)
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Additional participants enrolled at MTD of CP-870893 to further characterize suitability for phase 2 testing.
RP2D confirmed if ≤ 3 our of 12 participants in expansion cohort experience DLT in cycle 1.
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Baseline up to time of determination of maximum tolerated dose (MTD)
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Publicações e links úteis
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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 junho de 2008
Conclusão Primária (Real)
1 de janeiro de 2011
Conclusão do estudo (Real)
1 de janeiro de 2011
Datas de inscrição no estudo
Enviado pela primeira vez
26 de junho de 2008
Enviado pela primeira vez que atendeu aos critérios de CQ
7 de julho de 2008
Primeira postagem (Estimativa)
8 de julho de 2008
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
24 de dezembro de 2013
Última atualização enviada que atendeu aos critérios de controle de qualidade
26 de novembro de 2013
Última verificação
1 de novembro de 2013
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- A5021005
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Não
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