Hemotrial Un proyecto de SEHH

Ensayo clínico

A Randomized, Open Label Study of Oral CEP 701 Administered in Sequence With Standard Chemotherapy to Patients With Relapsed Acute Myeloid Leukemia (AML) Expressing FLT 3 Activating Mutations.Estudio abierto aleatorio del fármaco oral CEP-701 administrado consecutivamente con quimioterapia estándar en pacientes que han sufrido recaídas de leucemia mieloide aguda (LMA) mostrando mutaciones asociadas a la actividad del FLT-3

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Resumen

2017-03-15 03:57:24
2005-002258-23
C0701a/204/ON/US
A Randomized, Open Label Study of Oral CEP 701 Administered in Sequence With Standard Chemotherapy to Patients With Relapsed Acute Myeloid Leukemia (AML) Expressing FLT 3 Activating Mutations.Estudio abierto aleatorio del fármaco oral CEP-701 administrado consecutivamente con quimioterapia estándar en pacientes que han sufrido recaídas de leucemia mieloide aguda (LMA) mostrando mutaciones asociadas a la actividad del FLT-3
C0701a/204/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

Si
  INFORMACIÓN DE PLACEBOS USADOS:

No hay placebos asignados al ensayo

Información General

Leucemia Aguda

Relapsed Acute Myeloid Leukaemia (AML) expressing FLT-3 activating mutations.

The primary objective is to determine whether CEP 701 given in sequence with induction chemotherapy increases the proportion of patients with relapsed acute myeloid leukemia (AML) who achieve a second complete remission (CR) at the outcome assessment.

The secondary objectives of the study are to determine the following:• the proportion of patients who achieve an outcome of CR with incomplete blood count recovery (CRi) • the proportion of patients who achieve an outcome of partial remission (PR) • the proportion of patients who maintain an outcome of CR up to day 113• the proportion of patients who crossover to sequential CEP 701 treatment who achieve an outcome of CR at day 113 • remission duration (for patients who achieve a CR) • event-free survival • overall survival • safety and tolerability of CEP 701 administered in sequence with chemotherapy throughout the study• pharmacokinetics of CEP 701 at specified time points• CEP 701 inhibitory activity in plasma by means of a FLT 3 (fms-like tyrosine kinase 3) exvivo bioassay and cell assay at specified time points

Information no disponible en EudraCT


Patients are included in the study if all of the following criteria are met at the baseline visit:• cytological confirmation of AML• relapsed disease following first CR of a duration of 1 month (30 days) to 24 months (730 days). The time from first relapse to study entry (start of first course of induction chemotherapy) must be no longer than 30 days.• confirmation of FLT 3 activating mutation positive status after point of initial relapse• aged 18 years and older• written informed consent• ability to understand and comply with study restrictions• no comorbid conditions that would limit life expectancy to less than 3 months• Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1, or 2• women must be neither pregnant nor lactating, and either of nonchildbearing potential or using adequate contraception with a negative pregnancy test at study entry

Patients are excluded from participating in this study if 1 or more of the following criteria are met:• bilirubin levels greater than 2 times upper limit of normal (ULN), alanine transaminase or aspartate transaminase levels greater than 3 times ULN• serum creatinine concentrations greater than 1.5 mg/dL• resting ejection fraction of left ventricle less than 45% (applies only to patients scheduled to receive mitoxantrone, etoposide, and cytarabine [MEC])• untreated or progressive infection• any physical or psychiatric condition that may compromise participation in the study• known central nervous system involvement with AML• any previous treatment with a FLT 3 inhibitor• patient requires current treatment for the human immunodeficiency virus (HIV) with protease inhibitors• active gastrointestinal ulceration or bleeding • use of an investigational drug within 30 days of the baseline visit

The proportion of patients who achieve an outcome of complete remission at the outcome assessment.The secondary variables are as follows:• the proportion of patients who achieve an outcome of CRi or PR • the proportion of patients who maintain an outcome of CR up to day 113• the proportion of patients who achieve an outcome of CR at day 113 who crossover to sequential treatment with CEP 701• remission duration (for patients who achieve a CR) • event-free survival for all patients • overall survival for all patients

Fase II
  DISEÑO DEL ENSAYO:

No
Si

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
  COMPARADOR DEL ENSAYO CONTROLADO:

No
No

No
No

Si

Centros participantes:

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

2
5
  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:

16

Para estudios internacionales:

64
120

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


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