- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01253525
Study of Weekly Paclitaxel With Ramucirumab in Participants With Advanced Gastric Adenocarcinomas
16 de mayo de 2014 actualizado 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
6
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Chiba, Japón, 277-8577
- ImClone Investigational Site
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Osaka, Japón, 569-8686
- ImClone Investigational Site
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Osaka, Japón, 589-5811
- ImClone Investigational Site
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
20 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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
Otros nombres:
80 milligram/square meter (mg/m2) intravenously Days 1, 8, and 15 of each 28 day cycle
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Participants With a Dose-Limiting Toxicity (DLT) During Cycle 1
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 1
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de noviembre de 2010
Finalización primaria (Actual)
1 de octubre de 2011
Finalización del estudio (Actual)
1 de octubre de 2011
Fechas de registro del estudio
Enviado por primera vez
2 de diciembre de 2010
Primero enviado que cumplió con los criterios de control de calidad
2 de diciembre de 2010
Publicado por primera vez (Estimar)
3 de diciembre de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
18 de junio de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
16 de mayo de 2014
Última verificación
1 de mayo de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias por tipo histológico
- Neoplasias
- Carcinoma
- Neoplasias Glandulares y Epiteliales
- Adenocarcinoma
- Mecanismos moleculares de acción farmacológica
- Agentes antineoplásicos
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Agentes antineoplásicos, fitogénicos
- Paclitaxel
- Ramucirumab
Otros números de identificación del estudio
- 14204
- CP12-1026 (Otro identificador: ImClone Systems)
- I4T-IE-JVBW (Otro identificador: Eli Lilly and Company)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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