- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00752570
A Phase 2, Randomized, Double Blind, Placebo Controlled Study of AMG 386 in Combination With FOLFIRI in Subjects With Previously Treated Metastatic Colorectal Carcinoma
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the colon or rectum in patients who are presenting with metastatic disease
- One and only one prior chemotherapy regimen for metastatic disease consisting of the combination of a fluoropyrimidine-based chemotherapy and an oxaliplatin-based chemotherapy. Prior adjuvant chemotherapy used prior to the onset of metastatic disease is permitted
- At least one uni dimensionally measurable lesion per modified RECIST criteria. All sites of disease must be evaluated <= 28 days before randomization
- Radiographically documented disease progression per modified RECIST criteria either while receiving or <= 6 months after the last dose of prior chemotherapy regimen for metastatic disease
- ECOG performance status of 0 or 1
- Man or woman >= 18 years of age
- Adequate end organ assessments by laboratory studies (hematological and chemistries)
- Life expectancy >= 3 months
Exclusion Criteria:
Exclude subjects with a history of prior malignancy, except:
- Malignancy treated with curative intent and with no known active disease present for >= 3 years before enrollment and felt to be at low risk for recurrence by treating physician
- Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease
- Adequately treated cervical carcinoma in situ without evidence of disease
- Prostatic intraepithelial neoplasia without evidence of prostate cancer
- Prior irinotecan therapy
- Systemic chemotherapy, hormonal therapy, or immunotherapy <= 21 days prior to randomization
- Experimental or approved proteins/antibodies (eg, bevacizumab) <= 30 days prior to randomization
- Clinically significant cardiac disease within 12 months prior to randomization, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient medication, percutaneous transluminal coronary angioplasty/stent
- Known allergy or hypersensitivity to irinotecan, 5 FU (known dihydropyrimidine dehydrogenase deficiency) or leucovorin
- Active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as >= CTC grade 2 [CTCAE version 3.0])
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador de placebos: 2
AMG 386 placebo QW, FOLFIRI Q2W
|
AMG 386 placebo QW will be administered until subject develops disease progression, clinical progression, unacceptable toxicity, or withdraws consent.
Administration of FOLFIRI chemotherapy will commence on day 1 of each dosing week following the administration of AMG 386. FOLFIRI Q2W regimen: irinotecan 180 mg/m2 IV over 90 (+-15) minutes on Day 1, leucovorin 400 mg/m2 IV over 2 hrs on Day 1, 5 FU 400mg/m2 IV bolus, followed by 2400 mg/m2 continuous IV infusion over 46 hrs +- 2 hours. FOLFIRI will be administered until disease progression, FOLFIRI intolerability, death, or study withdrawal by the subject, investigator, or sponsor, whichever occurs earliest. |
Comparador activo: 1
Arm 1 : AMG 386 10 mg/kg QW, FOLFIRI Q2W
|
Administration of FOLFIRI chemotherapy will commence on day 1 of each dosing week following the administration of AMG 386. FOLFIRI Q2W regimen: irinotecan 180 mg/m2 IV over 90 (+-15) minutes on Day 1, leucovorin 400 mg/m2 IV over 2 hrs on Day 1, 5 FU 400mg/m2 IV bolus, followed by 2400 mg/m2 continuous IV infusion over 46 hrs +- 2 hours. FOLFIRI will be administered until disease progression, FOLFIRI intolerability, death, or study withdrawal by the subject, investigator, or sponsor, whichever occurs earliest.
AMG 386 (10 mg/kg QW) will be administered until subject develops disease progression, clinical progression, unacceptable toxicity, or withdraws consent.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
To estimate the treatment effect as measured by progression free survival (PFS) in subjects treated with AMG 386 + FOLFIRI relative to subjects treated with FOLFIRI + placebo.
Periodo de tiempo: The time frame will be event driven and will occur when 100 subjects have experienced a PFS event (radiographic disease progression or death).
|
The time frame will be event driven and will occur when 100 subjects have experienced a PFS event (radiographic disease progression or death).
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
To evaluate other measures of efficacy or clinical response including objective response rate (ORR), duration of response (DOR), overall survival (OS) in subjects treated with AMG 386 + FOLFIRI relative to subjects treated with FOLFIRI + placebo
Periodo de tiempo: Treatment phase or until disease progression
|
Treatment phase or until disease progression
|
To evaluate progression free survival and measures of efficacy by KRAS status
Periodo de tiempo: Treatment phase
|
Treatment phase
|
To evaluate patient reported outcomes (PROs), relative dose intensity, incidence of anti AMG 386 antibody formation, pharmacokinetics of AMG 386 (Cmax and AUC) and safety (incidence of AEs and significant laboratory changes)
Periodo de tiempo: Throughout study
|
Throughout study
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Neoplasias por tipo histológico
- Neoplasias
- Neoplasias por sitio
- Neoplasias Glandulares y Epiteliales
- Neoplasias del Sistema Digestivo
- Enfermedades Gastrointestinales
- Enfermedades del Colon
- Enfermedades intestinales
- Neoplasias Intestinales
- Enfermedades Rectales
- Carcinoma
- Neoplasias colorrectales
- Neoplasias Gastrointestinales
- Neoplasias colónicas
- Efectos fisiológicos de las drogas
- Agentes antineoplásicos
- Inhibidores de la angiogénesis
- Agentes moduladores de la angiogénesis
- Sustancias de crecimiento
- Inhibidores del crecimiento
- Trebananib
Otros números de identificación del estudio
- 20070307
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. .
Ensayos clínicos sobre AMG 386 Placebo
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AmgenTerminadoCarcinoma | Cáncer | Cáncer de ovarios | Cáncer de trompa de Falopio | Tumores sólidos | Oncología | Tumores | Metástasis | Neoplasias malignas ginecológicasBélgica, Estados Unidos, Australia
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National Cancer Institute (NCI)TerminadoSarcoma de tejido blando en adultos recidivante | Sarcoma de tejido blando en adultos en estadio III | Sarcoma de tejido blando en adultos en estadio IV | Angiosarcoma adultoEstados Unidos
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AmgenTerminadoCáncer | Cáncer de mama | Neoplasias de mama | Cáncer metastásico | Tumores de mama | Tumores sólidos | Oncología | Tumores | Metástasis | Cáncer de mama localmente recurrente y metastásicoEstados Unidos, Bélgica, Francia
-
AmgenTerminadoCarcinoma avanzado de células renales
-
AmgenTerminadoCáncer de ovarios | Cáncer de trompa de Falopio | Cáncer peritoneal primario
-
AmgenTerminadoInsuficiencia renal | Tumores sólidos avanzados | Enfermedad del riñonEstados Unidos
-
Chong Kun Dang PharmaceuticalDesconocidoHipertensión | DislipidemiasCorea, república de
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National Cancer Institute (NCI)TerminadoNeoplasia del Sistema Nervioso Central | Neoplasia SólidaEstados Unidos, Canadá
-
Chong Kun Dang PharmaceuticalTerminadoHipertensión y DislipidemiaCorea, república de