- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01021072
A First in Man Study of MABp1 in Patients With Advanced Cancers
A Phase 1 Study of MABp1 in Patients With Advanced Cancers
The purpose of this study is to block interleukin-1 alpha activity with a True Human monoclonal antibody, thus interrupting the inflammatory response that supports tumor growth/metastasis and which drives the cachexic process.
An adaptive design will be employed which will allow for the exploration of different dosing regimens, as well as tumor types that show preliminary evidence of efficacy.
Descripción general del estudio
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Texas
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Houston, Texas, Estados Unidos, 77030
- MD Anderson Cancer Center
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Houston, Texas, Estados Unidos, 77030
- M.D. Anderson Cancer Institute
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- pathologically confirmed advanced malignancy that is metastatic or unresectable and which is refractory to standard therapy or for which thee is no standard therapy that provides benefits for >/= 3 months
- measurable or non-measurable disease at baseline
- at least 4 weeks since the last dose of chemotherapy, radiation therapy, immunotherapy, or surgery; at least 6 weeks for therapy which is known to have delayed toxicity; at least 4 weeks since treatment with biologic/targeted therapies; at least 2 weeks since last hormonal therapy
- will not be treated with any other chemotherapy, immunotherapy, radiotherapy or investigational drug while enrolled on this protocol
- age >/= 18 year, male or female
- Eastern Cooperative Oncology Group performance status 0,1,or 2
- Serum potassium and magnesium levels within institutional normal limits. Total serum calcium or ionized calcium level must be greater than or equal to the low limit of normal.
- Adequate renal function, defined by serum creating </= 1.5 x ULN
- Adequate hepatic function
- Adequate bone marrow function WOCBP, a negative serum pregnancy test result at screening.
- WOCBP or men whose sexual partners are WOCBP who are willing to use an acceptable method of contraception for at least 1 month prior to study entry, for the duration of the study, and for at least 3 months after the last dose of study medication
- Signed and dated IRB approved ICF before any protocol specific screening procedures are performed
Exclusion Criteria:
- serious uncontrolled medical disorder or active infection which would impair the patient to receive protocol therapy.
- Uncontrolled or significant cardiovascular diseae
- dementia or altered mental status that would prohibit the understanding or rendering of informed consent
- not recovered from the adverse effects of prior therapy at the time of enrollment </= grade 1
- symptomatic brain metastases which are either untreated or uncontrolled by surgery and or radiotherapy
- received extensive prior radiation therapy to the bone marrow
- immunocompromised, including subjects know to be infected with HIV
- history of hypersensitivity to compounds of similar chemical or biologic composition to the antibody women how are pregnant or breastfeeding
- WOCBP or men whose sexual partners are WOCBP who are unwilling or unable to use an acceptable method of contraception for at least 1 month prior to study entry, for the duration of the study, and for at least 3 months after the last dose of study medication
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- 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: MTD
The study will utilize a standard 3+3 design for dose escalation.
Once the maximum tolerated dose has been reached, an expansion cohort, as well as tumor specific expansion cohorts will be explored.
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0.25 mg/kg,0.75 mg/kg,1.25 mg/kg, 3.75 mg/kg IV (in the vein) on day 1 of each 21 day cycle until progression or unacceptable toxicity develops.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Maximum tolerated dose
Periodo de tiempo: one year
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one year
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Tumor response
Periodo de tiempo: one year
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one year
|
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Cachexia Response
Periodo de tiempo: 8 weeks
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Change in LBT as measured by DEXA
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8 weeks
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2009-PT004
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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