Hemotrial Un proyecto de SEHH

Ensayo clínico

Estudio de extensión abierto del fármaco oral CEP-701 en pacientes con enfermedades malignas hematológicas y no hematológicas que han participado en un estudio clínico del CEP-701

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Resumen

2017-03-15 03:58:41
2005-005542-39
C0701a/501/ON/US
Estudio de extensión abierto del fármaco oral CEP-701 en pacientes con enfermedades malignas hematológicas y no hematológicas que han participado en un estudio clínico del CEP-701
C0701a/501/ON/US

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
Cephalon Inc. United States

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test
lestaurtinib
CEP-701 Oral solution
Oral use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg/ml milligram equal

25

Contenido del fármaco


Si
No

No
Information no disponible en EudraCT

No
No

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
No

No
No

No
  INFORMACIÓN DE PLACEBOS USADOS:

No hay placebos asignados al ensayo

Información General



Trasplante Hematopoyético

Patients with hematologic and non hematologic malignancies who have participated in a clinical study of CEP 701 may participate in this extension study.


To assess the safety and tolerability of long term administration of CEP 701 in patients with advanced malignancy.

To measure the time to objective disease progression.

Information no disponible en EudraCT


- Participation in a previous clinical study of oral CEP 701 and would benefit by continuing treatment with CEP 701. Patients randomized to chemotherapy alone in study C0701a/204/ON/US may also be included in this study if in the opinion of their physician they might benefit by receiving oral CEP-701.- Aged 18 years or older.Written informed consent is obtained.- Diagnosis of hematologic or non hematologic malignancy.- Patient must be willing and able to comply with study restrictions and to return to the clinic for clinical and follow up evaluations as specified in this protocol.- Enter this study within 30 days after participating in the previous clinical study of oral CEP 701; or, if the patient received chemotherapy after the previous study of oral CEP 701, within an interval of 3 to14 days after receiving the final dose of chemotherapy.- Women must be neither pregnant or lactating, and either not of child-bearing potential or using adequate contraception with a negative pregnancy test result at study entry.

- Active gastrointestinal ulceration or bleeding.- 1 or more of the following abnormal clinical chemistry laboratory values: ->bilirubin is more than 2 times the upper limit of normal (ULN) ->alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is more than 3 times ULN- Serum creatinine is more than 2.0 mg/dl- Non hematologic malignancy and 1 or more of the following abnormal hematology values: ->hemoglobin is below 9 g/dl ->platelet counts are below 100000/µl ->Absolute neutrophil counts are below 1500/µl- The patient requires current treatment for the human immunodeficiency virus (HIV) with protease inhibitors or requires potent CYP3A4 inhibitors including cyclosporine, clotrimazole, fluconazole, itraconazole, voriconazole, ketoconazole, erythromycin, clarithromycin, troleandomycin, and nefazodone

- Safety and tolerability will be assessed by evaluating adverse events (comprising withdrawals due to adverse events and serious adverse events including deaths), results of clinical laboratory tests, vital signs measurements, physical examination findings, and concomitant medication usage.- Time to objective disease progression will be determined as the number of days from the baseline visit to the day of assessment of objective disease progression in this extension study.

Fase II
  DISEÑO DEL ENSAYO:

No
No

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
Information no disponible en EudraCT
  COMPARADOR DEL ENSAYO CONTROLADO:

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
No

Si

Centros participantes:


Si
Information no disponible en EudraCT
  TIEMPO ESTIMADO DURACIÓN DEL ENSAYO:

2
6
  TIEMPO ESTIMADO DURACIÓN DEL ENSAYO EN ESPAÑA:


  POBLACIÓN DE PACIENTES EN EL ESTUDIO:
  Población de pacientes: 1

Rango de edad:


0
1

1

Sexo:


1
1

Número planeado de pacientes a incluir:


8

Para estudios internacionales:


28
100

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


Por Determinar



En Marcha