Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Cabazitaxel Compared to Topotecan for the Treatment of Small Cell Lung Cancer

30 de março de 2015 atualizado por: Sanofi

Randomized Phase II Study of Cabazitaxel Versus Topotecan in Small Cell Lung Cancer Patients With Progressive Disease During or After a First Line Platinum Based Chemotherapy

Primary Objective:

To demonstrate progression free survival (PFS) improvement for cabazitaxel compared to topotecan in participants with sensitive or resistant/refractory small cell lung cancer following a first line platinum based chemotherapy.

Secondary Objectives:

  • To assess disease progression free rate at 12 weeks
  • To assess Response Rate (Response Evaluation Criteria in Solid Tumor [RECIST] 1.1) and duration of response
  • To assess Overall Survival (OS)
  • To assess the Safety (National Cancer Institute - Common Toxicity Criteria [NCI-CTC] version 4.03)
  • To assess the Health-Related Quality of Life (HRQoL)

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

Participants are to be treated until progressive disease, unacceptable toxicity or refusal for further study treatment.

All participants are to be followed for disease progression documentation and for participant status until the study cut-off date.

Tipo de estudo

Intervencional

Inscrição (Real)

179

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

  • Alemanha
      • Großhansdorf, Alemanha, 22927
        • Investigational Site Number 276003
      • Löwenstein, Alemanha, 74245
        • Investigational Site Number 276006
  • Brasil
      • Porto Alegre, Brasil, 90610-000
        • Investigational Site Number 076001
  • Canadá
      • Montreal, Canadá, H3T 1E2
        • Investigational Site Number 124003
      • Oshawa, Canadá, L1G 2B9
        • Investigational Site Number 124002
      • Rimouski, Canadá, G5L 5T1
        • Investigational Site Number 124004
      • Toronto, Canadá, M5G 2M9
        • Investigational Site Number 124001
  • Chile
      • Santiago, Chile, 8380456
        • Investigational Site Number 152001
      • Santiago, Chile
        • Investigational Site Number 152005
  • Espanha
      • Badalona, Espanha, 08916
        • Investigational Site Number 724002
      • Barcelona, Espanha, 08035
        • Investigational Site Number 724004
      • Málaga, Espanha, 29010
        • Investigational Site Number 724005
      • Valencia, Espanha, 46026
        • Investigational Site Number 724001
  • Estados Unidos
    • Alabama
      • Muscle Shoals, Alabama, Estados Unidos, 35661
        • Investigational Site Number 840007
    • Nebraska
      • Omaha, Nebraska, Estados Unidos, 68114
        • Investigational Site Number 840005
    • New Hampshire
      • Lebanon, New Hampshire, Estados Unidos, 03756
        • Investigational Site Number 840006
    • Ohio
      • Middletown, Ohio, Estados Unidos, 45042
        • Investigational Site Number 840003
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
        • Investigational Site Number 840001
  • Federação Russa
      • Moscow, Federação Russa, 115478
        • Investigational Site Number 643001
      • St-Petersburg, Federação Russa, 197758
        • Investigational Site Number 643005
      • Tula, Federação Russa, 300053
        • Investigational Site Number 643006
      • Yaroslavl, Federação Russa, 150054
        • Investigational Site Number 643003
  • França
      • Brest, França, 29609
        • Investigational Site Number 250005
      • Caen Cedex, França, 14033
        • Investigational Site Number 250004
      • La Tronche, França, 38700
        • Investigational Site Number 250006
      • Lille, França, 59800
        • Investigational Site Number 250002
      • Saint-Herblain Cedex, França, 44805
        • Investigational Site Number 250003
      • Villejuif Cedex, França, 94805
        • Investigational Site Number 250007
  • Grécia
      • Athens, Grécia, 11522
        • Investigational Site Number 300005
      • Athens, Grécia, 11527
        • Investigational Site Number 300003
      • Heraklion, Grécia, 71110
        • Investigational Site Number 300001
      • Thessaloniki, Grécia, 54629
        • Investigational Site Number 300002
      • Thessaloniki, Grécia, 57010
        • Investigational Site Number 300004
  • Hungria
      • Budapest, Hungria, 1121
        • Investigational Site Number 348001
      • Budapest, Hungria, 1121
        • Investigational Site Number 348004
      • Budapest, Hungria, 1125
        • Investigational Site Number 348002
      • Törökbálint, Hungria, 2045
        • Investigational Site Number 348003
  • Itália
      • Genova, Itália, 16132
        • Investigational Site Number 380001
      • Livorno, Itália, 57123
        • Investigational Site Number 380002
      • Novara, Itália, 28100
        • Investigational Site Number 380005
      • Parma, Itália, 43100
        • Investigational Site Number 380004
  • Noruega
      • Oslo, Noruega, 0440
        • Investigational Site Number 578001
      • Stavanger, Noruega, 4011
        • Investigational Site Number 578003
      • Trondheim, Noruega, 7006
        • Investigational Site Number 578002
  • Polônia
      • Gdansk, Polônia, 80-952
        • Investigational Site Number 616004
      • Lublin, Polônia, 20-954
        • Investigational Site Number 616003
      • Poznan, Polônia, 60-569
        • Investigational Site Number 616002
      • Warszawa, Polônia, 02-781
        • Investigational Site Number 616001
  • Republica da Coréia
      • Seoul, Republica da Coréia, 120-752
        • Investigational Site Number 410001
      • Seoul, Republica da Coréia, 135-710
        • Investigational Site Number 410003
      • Seoul, Republica da Coréia, 138-736
        • Investigational Site Number 410002
  • Romênia
      • Cluj Napoca, Romênia, 400015
        • Investigational Site Number 642003
      • Cluj-Napoca, Romênia, 400015
        • Investigational Site Number 642005
      • Craiova, Romênia, 200385
        • Investigational Site Number 642001
      • Timisoara, Romênia
        • Investigational Site Number 642002
  • Ucrânia
      • Dnipropetrovsk, Ucrânia, 49102
        • Investigational Site Number 804002
      • Donetsk, Ucrânia, 83092
        • Investigational Site Number 804004
      • Lviv, Ucrânia, 70031
        • Investigational Site Number 804001

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 :

  • Histological/cytological proven locally advanced or metastatic small cell lung cancer with progressive disease during or after first line platinum based chemotherapy
  • Male or female greater than or equal to (>=) 18 years (or country's legal age of majority if greater than [>]18 years)
  • Participants with measurable disease, Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1)
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (<=) 1

Exclusion criteria:

  • Absence of signed and dated Institutional Review Board (IRB)-approved participant informed consent form prior to enrollment into the study
  • More than one prior chemotherapy regimen. Prior treatment with topotecan or taxanes
  • Less than 28 days elapsed from prior treatment with chemotherapy, radiotherapy or surgery to the time of randomization (Radiotherapy for bone pain palliation is allowed)
  • Adverse events (excluding alopecia) from any prior anticancer therapy of grade >1 (National Cancer Institute Common Terminology Criteria [NCI CTCAE] v4.03) at the time of randomization
  • Uncontrolled Central Nervous System (CNS) metastases: participants with CNS metastases may have previous irradiation, only participants with stable disease or response to irradiation who are without CNS symptoms and on a maximum steroid dose of dexamethasone 8 mg daily or equivalent could be included
  • Participants with known leptomeningeal metastases
  • History of other, invasive neoplasm requiring ongoing therapy
  • Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization
  • Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association class III or IV congestive heart failure, stroke or transient ischemic attack
  • Any severe acute or chronic medical condition, which could impair the ability of the participant to participate in the study or interfere with interpretation of study results
  • Known Human Immunodeficiency Virus (HIV) disease, or active hepatitis B or C (systematic testing was not required)
  • Pregnant or breast-feeding woman. Positive serum or urine pregnancy test prior to randomization
  • Participant with reproductive potential (M/F) who did not agree to use an accepted and effective method of contraception during the study treatment period and for at least 6 months after the completion of the study treatment. The definition of "effective method of contraception" was based on the investigator's judgment. Effective method of contraception should also be adapted to local regulation
  • History of hypersensitivity to polysorbate 80

  • Inadequate organ and bone marrow function as evidenced by:

    • Hemoglobin less than [<] 9.0 gram per deciliter (g/dL)
    • Absolute neutrophil count <1.5 x 10^9 per liter
    • Platelet count <100 x 10^9 per liter
    • Aspartate Aminotransferase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT) and/or alanine aminotransferase/Serum Glutamic-Pyruvic Transaminase (ALT/SGPT) >2.5 x Upper Limit of Normal (ULN)
    • Alkaline Phosphatase (AP) >2.5 x ULN. In case of liver metastases AP >5 x ULN
    • Total bilirubin >1.0 x ULN
    • Serum Creatinine >1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to Chronic Kidney Disease Epidemiology Collaboration formula, and creatinine clearance <60 milliliter per minute (mL/min) was exclude the participant.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Cabazitaxel
Medicamento: Cabazitaxel
Cabazitaxel 25 milligram per square meter (mg/m^2) intravenously (IV) on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
Outros nomes:
  • XRP6258
Comparador Ativo: Topotecano
Medicamento: Topotecan
Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Progression Free Survival (PFS)
Prazo: Randomization to first tumor progression/clinical deterioration or death (maximum 7.6 months)
PFS was defined as the time interval from the date of randomization to the date of occurrence of the first documented tumor progression or death due to any cause, whichever came first. Median PFS was estimated using the Kaplan-Meier method. Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study or unequivocal progression of existing non-target lesion. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions is also considered progression.
Randomization to first tumor progression/clinical deterioration or death (maximum 7.6 months)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Overall Survival
Prazo: From randomization to date of death (maximum 15 months)
Overall survival was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was to be censored at the last date the participant was known to be alive. Median time was estimated by Kaplan-Meier curve.
From randomization to date of death (maximum 15 months)
Progression Free Rate at Week 12
Prazo: Week 12
Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study or unequivocal progression of existing non-target lesion. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Death due to disease progression within 12 weeks without radiological documentation of progressive disease was counted as an event. Percentage of participants who were progression free at week 12 are reported.
Week 12
Overall Objective Tumor Response Rate
Prazo: Randomization to disease progression/occurrence (maximum 7.6 months)
Overall objective tumor response was defined as the proportion of participants with confirmed RECIST 1.1 achieving a complete response (CR) or partial response (PR). CR was defined as disappearance of all target/non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Percentage of participants with overall objective tumor response is reported.
Randomization to disease progression/occurrence (maximum 7.6 months)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Sanofi

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

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 março de 2012

Conclusão Primária (Real)

1 de abril de 2014

Conclusão do estudo (Real)

1 de abril de 2014

Datas de inscrição no estudo

Enviado pela primeira vez

22 de dezembro de 2011

Enviado pela primeira vez que atendeu aos critérios de CQ

27 de dezembro de 2011

Primeira postagem (Estimativa)

28 de dezembro de 2011

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

13 de abril de 2015

Última atualização enviada que atendeu aos critérios de controle de qualidade

30 de março de 2015

Última verificação

1 de março de 2015

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • ARD12166
  • 2011-003415-31 (Número EudraCT)
  • U1111-1123-3503 (Outro identificador: UTN)

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 Cabazitaxel

Pesquisar ensaios semelhantes

Patrocinadores e Colaboradores

Condições médicas

Intervenções de drogas

CROs by country

CROs in Saudi Arabia

Condições

Doenças Raras

Intervenções de drogas

Suplementos Alimentares

Patrocinador / Colaboradores

Localizações

3
Se inscrever