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Efficacy/Safety of Imprime PGG With Cetuximab & Paclitaxel/Carboplatin Therapy in Pts With Untreated Advanced Non-Small Cell Lung Cancer

6 de outubro de 2016 atualizado por: HiberCell, Inc.

Efficacy and Safety Study of Imprime PGG® Injection in Combination With Cetuximab and Concomitant Paclitaxel and Carboplatin Therapy in Patients With Previously Untreated Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer

The Phase 2 study described in this protocol will serve to evaluate the antitumor activity, safety and pharmacokinetic profile of Imprime PGG when combined with cetuximab and concomitant paclitaxel and carboplatin therapy in patients with previously untreated advanced NSCLC. Additionally, this study will provide guidance for the design of more definitive efficacy studies of Imprime PGG in NSCLC patients.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

90

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
      • Berlin, Alemanha
        • Helios Clinic Emil von Behring
      • Frankfurt, Alemanha
        • Municipal Clinic Frankfurt Hoescht
      • Gottingen, Alemanha, 37075
        • Georg-August University Göttingen
      • Heidelberg, Alemanha
        • University Clinical Heidelberg
      • Minden, Alemanha
        • Clinic Minden
      • Munich, Alemanha
        • Techincal University of Munich
      • Nuremberg, Alemanha
        • Clinic Nurnberg Nord
      • Ulm, Alemanha, 89081
        • Universitätsklinikum Ulm
      • Wuppertal, Alemanha, 42283
        • HELIOS Klinikum Wuppertal, Medizinische Klinik 1
  • Estados Unidos
    • Georgia
      • Augusta, Georgia, Estados Unidos, 30912
        • Medical College of Georgia
    • Indiana
      • Terre Haute, Indiana, Estados Unidos, 47802
        • Providence Medical Group
    • Minnesota
      • Minneapolis, Minnesota, Estados Unidos, 55455
        • University of Minnesota
    • Texas
      • Dallas, Texas, Estados Unidos, 75201
        • Mary Crowley Medical Research Center
      • Midland, Texas, Estados Unidos, 79701
        • Allison Cancer Center

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 a 75 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  1. Has read, understood and signed the informed consent form (ICF) approved by the Independent Review Board/Ethics Committee (IRB/EC)
  2. Is between the ages of 18 and 75 years old, inclusive
  3. Has histologically or cytologically confirmed stage IIIB (malignant pericardial or pleural effusion) or stage IV non-small cell lung cancer
  4. Has measurable disease, defined as at least one tumor that fulfills the criteria for a target lesion according to RECIST
  5. Has an ECOG performance status of 0 or 1
  6. Has a life expectancy of > 3 months

  7. Has adequate hematologic function as evidenced by:

    • ANC ≥ 1,500/μL
    • PLT ≥ 100,000/μL
    • HGB ≥ 9 g/dL obtained within 1 week prior to the first dose of study medication;

  8. Has adequate renal function as evidenced by:

    • Serum creatinine ≤ 1.5 X the upper limit of normal (ULN) for the reference lab
    • Urine dipstick for proteinuria of < 1+ (i.e., either 0 or trace) within 2 weeks of Day 1 If urine dipstick is ≥ 1+, then urine protein excretion must be ≤ 500 mg over a 24 hour collection obtained within 1 week prior to the first dose of study medication;

  9. Has adequate hepatic function as evidenced by:

    • Serum total bilirubin ≤ 1.0 mg/dL
    • AST ≤ 2.5X ULN for the reference lab (≤ 5X ULN for subjects with known hepatic metastases)
    • ALT ≤ 2.5X ULN for the reference lab (≤ 5X ULN for subjects with known hepatic metastases) obtained within 1 week prior to the first dose of study medication;
  10. If a woman of childbearing potential or a fertile man (and his partners), must agree to use an effective form of contraception (hormonal contraceptive, double-barrier method or abstinence) during the study.

Exclusion Criteria:

  1. Has received prior systemic chemotherapy at any time for lung cancer;
  2. Has received previous radiation therapy to >30% of active bone marrow or any radiation therapy within 3 weeks of Day 1
  3. Has a known hypersensitivity to baker's yeast, or has an active yeast infection
  4. Has had previous exposure to Betafectin® or Imprime PGG
  5. Has an active infection

  6. Presents with any of the following medical diagnoses/conditions at the time of screening:

    • Central nervous system (CNS) metastases
    • Uncontrolled hypertension (>150/100 mmHg) or hypertension that requires > two agents for adequate control
    • Peripheral neuropathy ≥ grade 2 from any cause
    • Fever of >38.5° C within 3 days prior to screening or Day 1, initial dosing
    • Known HIV/AIDs, Hepatitis B, Hepatitis C, connective tissue or autoimmune disease, or other clinical diagnosis, ongoing or intercurrent illness that in the physician's opinion could interfere with participation

  7. Has a history of any of the following medical diagnoses/conditions:

    • Myocardial infarction or an unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure) within the previous 6 months
    • Second malignancy within the previous 5 years, other than basal cell carcinoma, cervical intra-epithelial neoplasia or curatively treated prostate cancer with a PSA of <2.0 ng/mL
  8. Has a known hypersensitivity to cetuximab, murine proteins, or any component of cetuximab
  9. Has a know sensitivity to Cremophor EL
  10. Has previously received treatment with cetuximab
  11. If female, is pregnant or breast-feeding
  12. Is receiving concurrent investigational therapy or has received investigational therapy within a period of 30 days prior to the first scheduled day of dosing (investigational therapy is defined as treatment for which there is currently no regulatory-authority-approved indication)
  13. Has previously received an organ or progenitor/stem cell transplant.

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: Imprime PGG
Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
Biológico: Imprime PGG Injection
4 mg/kg i.v. over 2 hrs, weekly, in three week cycles
Biológico: Cetuximab
initial loading dose of 400 mg/m^2 over 120 min and subsequent doses at 250 mg/m^2 over 60 min, weekly on Days 1, 8 and 15 of each 3-week treatment cycle
Outros nomes:
  • Erbitux
Medicamento: Paclitaxel
200 mg/m^2 i.v. over 3 hr on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
Outros nomes:
  • Taxol
  • Abraxane
  • Nov-Onxol
  • Onxol
Medicamento: Carboplatin
dose equal to an AUC of 6 mg/mL · min based on the Calvert formula; i.v. over 30 min on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
Outros nomes:
  • Paraplatina
Comparador Ativo: Control
Cetuximab + Paclitaxel/Carboplatin
Biológico: Cetuximab
initial loading dose of 400 mg/m^2 over 120 min and subsequent doses at 250 mg/m^2 over 60 min, weekly on Days 1, 8 and 15 of each 3-week treatment cycle
Outros nomes:
  • Erbitux
Medicamento: Paclitaxel
200 mg/m^2 i.v. over 3 hr on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
Outros nomes:
  • Taxol
  • Abraxane
  • Nov-Onxol
  • Onxol
Medicamento: Carboplatin
dose equal to an AUC of 6 mg/mL · min based on the Calvert formula; i.v. over 30 min on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
Outros nomes:
  • Paraplatina

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Objective Response Rate (ORR) in Each Study Arm Based on Independent Central Radiology Review
Prazo: From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months

Overall objective response rate was defined as the number of participants experiencing a best overall response of either complete response (CR) or partial response (PR) based on the modified RECIST v1.0 criteria.

The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines.
From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Overall Survival (OS) in Each Study Arm Based on the Safety Population
Prazo: From the time of randomization to death, subject being lost to follow-up or study completion
Overall survival (OS) was defined as the time from the date of randomization until the date of documented death of the subject due to any cause, including death due to relapses that were successfully retreated. Subjects who were lost to follow-up or who were still alive at the time of analysis were censored at the last contact dates.
From the time of randomization to death, subject being lost to follow-up or study completion
Disease Control Rate (DCR) in Each Study Arm Based on Independent Central Radiology Review
Prazo: From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months

The disease control rate (DCR) was defined as the number of participants experiencing a best overall tumor response of either CR, PR or SD. For stable disease (SD), follow-up measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks.

The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines.
From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months
Complete Response (CR), Partial Response (PR), and Stable Disease (SD) Rates in Each Study Arm Based on Independent Central Radiology Review
Prazo: From the first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months

The best observed overall response rates were defined as the number of participants experiencing a best overall response of either complete response (CR), partial response (PR) or stable disease (SD) based on the modified RECIST v1.0 criteria. For stable disease (SD), follow-up measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks.

The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines.
From the first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months
Duration of Objective Tumor Response in Each Study Arm Based on Independent Central Radiology Review
Prazo: From the first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months

The duration of objective tumor response was measured from the time at which criteria are met for CR or PR (whichever status is recorded first) until the first date on which recurrence or progressive disease is objectively documented per modified RECIST v1.0. Subjects who did not progress as of the data cutoff date were censored at their last tumor assessment date.

The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines.
From the first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months
Duration of Time to Progression (TTP) in Each Study Arm Based on Independent Central Radiology Review
Prazo: From time of randomization to first date of documented progression, or last tumor assessment date, up to 15 months

Time-to-progression (TTP) was defined as the time from the date of randomization to the first date of documented progressive disease. Progressive disease was identified by radiologic progressive disease according to modified RECIST v1.0, or in the case of the Investigator Radiologic Review, it may also be defined by clinical progression as determined by the investigator.

If a subject received any further anti-cancer therapy without prior documentation of disease progression, the subject was censored at the date of last tumor assessment before starting anti-cancer treatment. Subjects who died on study from other causes (not related to study disease) and subjects who were lost to follow-up or who were alive without documented progressive disease as of the data cut-off date for analysis were censored at the last tumor assessment date.
From time of randomization to first date of documented progression, or last tumor assessment date, up to 15 months

Colaboradores e Investigadores

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

Patrocinador

HiberCell, Inc.

Investigadores

  • Investigador principal: Folker Schneller, MD, Technical University, Munich

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 agosto de 2009

Conclusão Primária (Real)

1 de novembro de 2012

Conclusão do estudo (Real)

1 de agosto de 2015

Datas de inscrição no estudo

Enviado pela primeira vez

1 de abril de 2009

Enviado pela primeira vez que atendeu aos critérios de CQ

2 de abril de 2009

Primeira postagem (Estimativa)

3 de abril de 2009

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

29 de novembro de 2016

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de outubro de 2016

Última verificação

1 de outubro de 2016

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • BT-CL-PGG-LCA0822

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

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 .

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