Open Label Trial of Perifosine in Patients Currently Being Treated on Perifosine Trials in Solid Tumors or Multiple Myeloma
An Open Label Trial of Perifosine in Patients Currently Being Treated on Perifosine Trials in Solid Tumors or Multiple Myeloma
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Perifosine is an oral anticancer agent with limited toxicity and a novel mechanism of action that is distinctly different from cytotoxic chemotherapies. It has been shown to inhibit and otherwise modify signaling through a number of pathways including Akt, p21, and JNK. Perifosine has been tested in Phase I and Phase II settings in a variety of dosing schedules including daily, weekly, and daily following a loading dose. In general, it has been well tolerated with dose-related nausea, vomiting, diarrhea, and fatigue being the most commonly observed toxicities.
Perifosine has induced partial responses or stable disease in solid tumors including but not limited to renal cell, sarcoma, and hepatocellular carcinoma. Perifosine is currently being studied in multiple diseases as a single agent as well as in combination with other cancer therapies. As studies are closed there are patients that have achieved a partial response or stable disease.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Patients must be currently receiving treatment with perifosine on a previously approved protocol.
- Patients must have had at least one evaluation following the initiation of treatment and have stable disease, partial response or complete response.
- Patient is willing to sign a new consent Regarding the protocol no exclusion criteria are described.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Perifosine 201
Perifosine 201: A Phase 1/2 trial of Perifosine in the Treatment of Non-Small Cell Lung Cancer. Perifosine dosage: Arm A: 50 mg p.o. 3 times daily with meals. Arm B: 150 mg p.o. daily at bedtime. Arm C: 300 mg p.o. 3 times a day (900 mg) once a week. |
All patients should continue therapy on their current regimen until disease progression.
The trial specific intervention is specified in the arms descriptions.
Otros nombres:
|
|
Experimental: Perifosine 206
Perifosine 206: A Randomized Phase II Trial of Three Doses of Perifosine in Combination with Trastuzumab. Arm A: Perifosine 50 mg p.o. daily + 6 mg/kg Trastuzumab on day 1 of a 21-day cycle or 2 mg/kg on days 1, 8 and 15 of a 21 day cycle. Arm B: Perifosine 50 mg p.o three times a day + 6 mg/kg Trastuzumab on day 1 of a 21-day cycle or 2 mg/kg on days 1, 8 and 15 of a 21 day cycle. Arm C: Perifosine 300 mg three times on one day + 6 mg/kg Trastuzumab on day 1 of a 21-day cycle or 2 mg/kg on days 1, 8 and 15 of a 21 day cycle. |
All patients should continue therapy on their current regimen until disease progression.
The trial specific intervention is specified in the arms descriptions.
Otros nombres:
Trastuzumab was given 6mg/kg i.v.
daily or 2 mg/kg i.v. on day 1, 8 and 15.
|
|
Experimental: Perifosine 207
Perifosine 207: a Phase IIA Trial of Two Schedules of Perifosine Arm A: 50 mg daily with food.
Arm B: 50 mg twice daily with food.
|
All patients should continue therapy on their current regimen until disease progression.
The trial specific intervention is specified in the arms descriptions.
Otros nombres:
|
|
Experimental: Perifosine 208
Perifosine 208: A Phase II Trial of Two Schedules of Perifosine in Combination with Endocrine Therapy (Tamoxifen) for Patients with Estrogen Receptor or Progesterone Receptor Positive Metastatic Breast Cancer Dosage: Arm A: 50 mg Perifosine /day p.o. .Endocrine therapy continued at same dose and schedule.
Arm B: 900 Perifosine weekly.
Endocrine therapy continued at same dose and schedule.
|
All patients should continue therapy on their current regimen until disease progression.
The trial specific intervention is specified in the arms descriptions.
Otros nombres:
Endocrine therapy with tamoxifen will be evaluated in combination with perifosine to determine if the combination overcomes resistance to endocrine therapy .
|
|
Experimental: Perifosine 209
Perifosine 209: A Phase II Trial of Perifosine in Patients with Sarcomas.
Perifosine 900 mg weekly (This dose should be divided so that the maximum dose rate is 300 mg in any 4-hour interval).
|
All patients should continue therapy on their current regimen until disease progression.
The trial specific intervention is specified in the arms descriptions.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
To evaluate the safety and tolerability
Periodo de tiempo: 12 weeks
|
To evaluate the safety and tolerability of perifosine as a single agent as well as in combination with hormonal therapies or trastuzumab.
|
12 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Eric Grossman, MD, Keryx Biopharmaceuticals, Inc., NY 10022-9819
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 (Actual)
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 cardiovasculares
- Enfermedades Vasculares
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Neoplasias
- Trastornos linfoproliferativos
- Trastornos inmunoproliferativos
- Enfermedades hematológicas
- Trastornos hemorrágicos
- Trastornos hemostáticos
- Paraproteinemias
- Trastornos de proteínas en sangre
- Neoplasias De Células Plasmáticas
- Mieloma múltiple
- Efectos fisiológicos de las drogas
- Agentes antineoplásicos
- Hormonas, sustitutos hormonales y antagonistas hormonales
- Agentes Antineoplásicos Hormonales
- Agentes antineoplásicos inmunológicos
- Antagonistas de hormonas
- Agentes de conservación de la densidad ósea
- Antagonistas de estrógeno
- Moduladores selectivos del receptor de estrógeno
- Moduladores del receptor de estrógeno
- Trastuzumab
- Tamoxifeno
Otros números de identificación del estudio
- Perifosine 534
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