- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01253525
Study of Weekly Paclitaxel With Ramucirumab in Participants With Advanced Gastric Adenocarcinomas
16 de maio de 2014 atualizado por: Eli Lilly and Company
A Phase 1b Study of Weekly Paclitaxel With Ramucirumab (IMC-1121B) Drug Product in Patients With Advanced Gastric Adenocarcinomas
Investigate the safety and tolerability of ramucirumab (IMC-1121B) drug product (DP) in combination with paclitaxel.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
6
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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Chiba, Japão, 277-8577
- ImClone Investigational Site
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Osaka, Japão, 569-8686
- ImClone Investigational Site
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Osaka, Japão, 589-5811
- ImClone 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
20 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Has a histopathologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction (GEJ) adenocarcinoma
- Has an advanced or metastatic solid gastric adenocarcinoma that has failed standard therapy
- Has resolution of all clinically significant toxic effects of prior therapy, surgery, treatment with an investigational agent or device, treatment monoclonal antibody or small molecule, and radiotherapy or chemotherapy.
- Has adequate organ function
- Eligible participants of reproductive potential (both sexes) agree to use adequate contraceptive methods (hormonal or barrier methods) during the study period and for 12 weeks after the last dose of study medication
Exclusion Criteria:
- Has undergone major surgery within 28 days prior to the study, or subcutaneous venous access device placement within 7 days prior to the study registration date
- Has elective or planned surgery to be conducted during the trial
- Has had treatment with an investigational agent or device, an antineoplastic small molecule, or antineoplastic radiotherapy or chemotherapy
- Was previously treated with a chemotherapy regimen containing nitrosoureas or mitomycin C
- Has had treatment with an antineoplastic monoclonal antibody within 8 weeks prior to the study registration date
- Has a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism prior to the study registration date
- Has experienced any arterial thrombotic event, including myocardial infarction, cerebrovascular accident, or transient ischemic attack, within 6 months prior to the study date
- Is receiving therapeutic anticoagulation with warfarin, low-molecular weight heparin or similar agents. (Participants receiving prophylactic, low-dose anticoagulation therapy are eligible provided that the coagulation parameters International Normalized Ratio (INR) ≤ 1.5, prothrombin time (PT) and partial thromboplastin time (PTT) or - Is receiving chronic therapy with nonsteroidal anti-inflammatory agents [Aspirin use at doses up to 325 milligrams/day (mg/day) is permitted]
- Has significant bleeding disorders, vasculitis, history of postoperative bleeding complications, hemoptysis or had a significant bleeding episode from the gastrointestinal (GI) tract within 3 months prior to the study date
- Has a history of GI perforation and/or fistulae within 6 months prior to the study date
- Has symptomatic congestive heart failure, unstable angina pectoris, or symptomatic or poorly controlled cardiac arrhythmia
- Has uncontrolled arterial hypertension despite standard medical management.
- Has a serious or nonhealing wound or peptic ulcer or bone fracture within 28 days prior to the study date
- Has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection, Crohn's disease, ulcerative colitis, or chronic diarrhea
- Has a serious illness or medical condition(s)
- Is pregnant or lactating
- Has received treatment with another investigational drug or participation in another interventional clinical trial within 28 days prior to the study date
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 de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Ramucirumab (IMC-1121B ) and Pacitaxel
Each treatment cycle is 4 weeks (28 days)
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8 milligrams/kilogram (mg/kg) intravenously on Days 1 and 15 of each 28-ay cycle
Outros nomes:
80 milligram/square meter (mg/m2) intravenously Days 1, 8, and 15 of each 28 day cycle
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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 With a Dose-Limiting Toxicity (DLT) During Cycle 1
Prazo: Cycle 1 of 28-day cycle
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DLT based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE v4.02) in Cycle (Cy) 1 due to study drug (SD) with (w/): Grade (Gr) ≥3 neutropenia w/fever ≥38.5°C or w/bacteremia or sepsis, thrombocytopenia w/bleeding and platelet substitution, prothrombin and/or partial thromboplastin time w/no anticoagulation, hyperbilirubinemia; Gr 4: neutropenia >5 days, thrombocytopenia, Gr 4 or uncontrollable hypertension QTc>500 milliseconds (ms) or increase ≥100 ms increase in 24 hours after SD or significant arrhythmia in this period; Gr ≥3 nonhematologic toxicity (tox), excluding Gr 3 hypersensitivity, hypertension, injection-site reaction, arthralgia/myalgia, asthenia/fatigue, diarrhea w/out loperamide/nausea/vomiting w/out antiemetic and transient aminotransferase elevation.
SD tox=delay >1 week in ramucirumab (RAM) dose or omission of 1 dose of RAM or 2 paclitaxel doses due to tox in Cy 1 or delay >2 weeks between Cy 1 and Cy 2 due to persistent tox.
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Cycle 1 of 28-day cycle
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Number of Participants With Adverse Events (AEs)
Prazo: Up to 47 weeks post baseline
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The number of participants who experienced AEs of any grade, AEs of Grade ≥3 or AEs resulting in death that were considered to be related to ramucirumab [RAM (IMC-1121B)] or paclitaxel (PAC).
A summary of serious adverse events (SAEs) and all other non-SAEs, regardless of causality, is located in the Reported Adverse Events module.
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Up to 47 weeks post baseline
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Number of Participants With Serious Adverse Events (SAEs)
Prazo: Up to 47 weeks post baseline
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The number of participants who experienced SAEs that were considered to be related to ramucirumab [RAM (IMC-1121B)] or paclitaxel (PAC).
A summary of SAEs and all other non-SAEs, regardless of causality, is located in the Reported Adverse Events module.
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Up to 47 weeks post baseline
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 1
Prazo: Cycle 1 Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Cmax after a single dose of ramucirumab (IMC-1121B).
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Cycle 1 Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Serum Anti-Ramucirumab Antibody Assessment (Immunogenicity)
Prazo: Cycle 1 through Cycle 5 (28-day cycles)
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The percentage of participants who were treatment-emergent positive for anti-ramucirumab (IMC-1121B) antibodies.
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Cycle 1 through Cycle 5 (28-day cycles)
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Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 1
Prazo: Cycle 1 Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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AUC from time 0 to infinity (0-∞) after a single dose of ramucirumab (IMC-1121B).
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Cycle 1 Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Ramucirumab Half-Life (t1/2) for Cycle 1
Prazo: Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Terminal t1/2 (the time it takes for the concentration of ramucirumab (IMC-1121B) in plasma or serum to decline by 50%) after a single dose of ramucirumab (IMC-1121B).
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Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Ramucirumab Clearance (CL) or Cycle 1
Prazo: Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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CL [the volume of plasma or serum cleared of ramucirumab (IMC-1121B) per unit time] after a single dose of ramucirumab (IMC-1121B).
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Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 1
Prazo: Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Vss [distribution of ramucirumab (IMC-1121B) in the body at steady state] after a single dose of ramucirumab (IMC-1121B).
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Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 2
Prazo: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Cmax after multiple doses of ramucirumab (IMC-1121B).
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Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 2
Prazo: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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AUC within the dosing interval (0-τ) after multiple doses of ramucirumab (IMC-1121B).
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Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Ramucirumab Half-Life (t1/2) for Cycle 2
Prazo: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Terminal t1/2 [the time it takes for the concentration of ramucirumab (IMC-1121B) in plasma or serum to decline by 50%] after multiple doses of ramucirumab(IMC-1121B).
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Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Ramucirumab Clearance (CL) for Cycle 2
Prazo: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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CL [the volume of plasma or serum cleared of ramucirumab (IMC-1121B) per unit time] at steady state after multiple doses of ramucirumab (IMC-1121B).
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Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 2
Prazo: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Vss [distribution of ramucirumab (IMC-1121B) in in the body at steady state] is not calculated for multiple doses of ramucirumab (IMC-1121B).
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Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
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Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 3
Prazo: Cycle 3: Pre-infusion, Day 1 of 28-day cycle
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Due to sparse pharmacokinetic sampling ramucirumab (IMC-1121B) Cmax could not be calculated in Cycle 3.
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Cycle 3: Pre-infusion, Day 1 of 28-day cycle
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Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 3
Prazo: Cycle 3: Pre-infusion, Day 1 of 28-day cycle
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Due to the sparse pharmacokinetic sampling ramucirumab (IMC-1121B) AUC within the dosing interval (0-τ) could not be calculated in Cycle 3.
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Cycle 3: Pre-infusion, Day 1 of 28-day cycle
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Ramucirumab Half-Life (t 1/2) for Cycle 3
Prazo: Cycle 3: Pre-infusion, Day 1 of 28-day cycle
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Due to sparse pharmacokinetic sampling ramucirumab (IMC-1121B) t1/2 could not be calculated in Cycle 3.
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Cycle 3: Pre-infusion, Day 1 of 28-day cycle
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Ramucirumab Clearance (CL) for Cycle 3
Prazo: Cycle 3: Pre-infusion, Day 1 of 28-day cycle
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Due to sparse pharmacokinetic sampling CL could not be calculated for ramucirumab (IMC-1121B) in Cycle 3.
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Cycle 3: Pre-infusion, Day 1 of 28-day cycle
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Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 3
Prazo: Cycle 3: Pre-infusion, Day 1 of 28-day cycle
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Due to sparse pharmacokinetic sampling Vss for ramucirumab (IMC-1121B) could not be calculated in Cycle 3.
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Cycle 3: Pre-infusion, Day 1 of 28-day cycle
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Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 4
Prazo: Cycle 4: Pre-infusion, Day 1 of 28-day cycle
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Due to sparse pharmacokinetic sampling ramucirumab (IMC-1121B) Cmax could not be calculated in Cycle 4.
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Cycle 4: Pre-infusion, Day 1 of 28-day cycle
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Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 4
Prazo: Cycle 4: Pre-infusion, Day 1 of 28-day cycle
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Due to sparse pharmacokinetic sampling AUC within the dosing interval (0-τ) for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.
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Cycle 4: Pre-infusion, Day 1 of 28-day cycle
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Ramucirumab Half-Life (t 1/2) for Cycle 4
Prazo: Cycle 4: Pre-infusion, Day 1 of 28-day cycle
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Due to sparse pharmacokinetic sampling t1/2 for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.
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Cycle 4: Pre-infusion, Day 1 of 28-day cycle
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Ramucirumab Clearance (CL) for Cycle 4
Prazo: Cycle 4: Pre-infusion, Day 1 of 28-day cycle
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Due to sparse pharmacokinetic sampling CL for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.
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Cycle 4: Pre-infusion, Day 1 of 28-day cycle
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Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 4
Prazo: Cycle 4: Pre-infusion, Day 1 of 28-day cycle
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Due to sparse pharmacokinetic sampling Vss for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.
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Cycle 4: Pre-infusion, Day 1 of 28-day cycle
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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.
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 novembro de 2010
Conclusão Primária (Real)
1 de outubro de 2011
Conclusão do estudo (Real)
1 de outubro de 2011
Datas de inscrição no estudo
Enviado pela primeira vez
2 de dezembro de 2010
Enviado pela primeira vez que atendeu aos critérios de CQ
2 de dezembro de 2010
Primeira postagem (Estimativa)
3 de dezembro de 2010
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
18 de junho de 2014
Última atualização enviada que atendeu aos critérios de controle de qualidade
16 de maio de 2014
Última verificação
1 de maio de 2014
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Neoplasias por Tipo Histológico
- Neoplasias
- Carcinoma
- Neoplasias Glandulares e Epiteliais
- Adenocarcinoma
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Antineoplásicos
- Moduladores de Tubulina
- Agentes Antimitóticos
- Moduladores de Mitose
- Agentes Antineoplásicos Fitogênicos
- Paclitaxel
- Ramucirumabe
Outros números de identificação do estudo
- 14204
- CP12-1026 (Outro identificador: ImClone Systems)
- I4T-IE-JVBW (Outro identificador: Eli Lilly and Company)
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 .