Hemotrial Un proyecto de SEHH

Ensayo clínico

Estudio de fase 3, abierto y aleatorizado, de bosutinib comparado con imatinib en sujetos con leucemia mieloide crónica cromosoma Filadelfia positiva en fase crónica, de diagnóstico recienteA Phase 3 Randomized, Open-Label Study of Bosutinib Versus Imatinib in Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myelogenous Leukemia

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Estudio de fase 3, abierto y aleatorizado, de bosutinib comparado con imatinib en sujetos con leucemia mieloide crónica cromosoma Filadelfia positiva en fase crónica, de diagnóstico recienteA Phase 3 Randomized, Open-Label Study of Bosutinib Versus Imatinib in Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myelogenous Leukemia


Resumen

2017-03-15 04:05:44
2007-003780-50
3160A4-3000-WW
Estudio de fase 3, abierto y aleatorizado, de bosutinib comparado con imatinib en sujetos con leucemia mieloide crónica cromosoma Filadelfia positiva en fase crónica, de diagnóstico recienteA Phase 3 Randomized, Open-Label Study of Bosutinib Versus Imatinib in Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myelogenous Leukemia
3160A4-3000-WW

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
Wyeth Research Division of Wyeth Pharmaceuticals Inc. United States

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test Glivec
Novartis Europharm Ltd BOSUTINIB
SKI-606 Film-coated tablet
Oral use

Detalles del Fármaco (Principio Activo):

SKI-606

Concentración del fármaco:

mg milligram(s) equal

100

Contenido del fármaco


Si
No

No
Information no disponible en EudraCT

No
No

No
No

Information no disponible en EudraCT
No

No
No

No
  FÁRMACO 2:
Test Glivec
Novartis Europharm Ltd BOSUTINIB
SKI-606 Film-coated tablet
Oral use

Detalles del Fármaco (Principio Activo):

SKI-606

Concentración del fármaco:

mg milligram(s) equal

500

Contenido del fármaco


Si
No

No
Information no disponible en EudraCT

No
No

No
No

Information no disponible en EudraCT
No

No
No

No
  FÁRMACO 3:
Comparator
Film-coated tablet
Oral use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg milligram(s) equal

400

Contenido del fármaco


Si
No

No
Information no disponible en EudraCT

No
No

No
No

Information no disponible en EudraCT
No

No
No

No
  FÁRMACO 4:
Comparator
Film-coated tablet
Oral use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg milligram(s) equal

100

Contenido del fármaco


Si
No

No
Information no disponible en EudraCT

No
No

No
No

Information no disponible en EudraCT
No

No
No

No
  INFORMACIÓN DE PLACEBOS USADOS:

No hay placebos asignados al ensayo

Información General



Sindromes Mieloproliferativos

Leucemia mieloide crónica (LMC)Chronic myelogenous leukemia (CML)


Compare the rate of complete cytogenetic response (CCyR) at one year in chronic phase subjects receiving bosutinib alone versus chronic phase subjects receiving imatinib alone.

Estimate the major molecular response (MMR) rate at one year.Estimate the duration of CCyR, CHR, and MMR.Estimate the time to transformation to accelerated phase (AP) and blast phase (BP).Assess the population PK of bosutinib.Assess comparative safety of bosutinib vs. imatinib

No


Cytogenetic diagnosis of chronic phase Ph+ CML diagnosed for ? 6 months.2. Adequate hepatic, and renal function.3. ECOG Performance status of 0 or 1.4. Age ? 18 years.5. Recovered to ? grade 1 or baseline from any toxicities of prior anti-cancer treatment.6. Negative serum pregnancy test within two weeks of the first dose of test article if the subject is a woman of childbearing potential. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose sexual partners are eithersterile or using contraceptives.7. Willingness of all subjects who are not surgically sterile or postmenopausal to agree and commit to the use of a reliable method of birth control for the duration of the study and for 28 days after the last dose of test article.

1. Philadelphia chromosome negative CML.2. Prior anti-leukemia treatment. Up to 6 months of prior hydroxyurea or anagrelide treatment is allowed.3. Identified stem cell donor with transplant planned within 12 months of randomization.4. Prior stem cell transplant5. Central nervous system leukemia.6. Extramedullary disease only.7. History of accelerated or blast phase CML.8. Major surgery or radiotherapy within 14 days of randomization.9. Concomitant use of or need for medications known to prolong the QT interval.10. History of clinically significant or uncontrolled cardiac disease11. Known seropositivity to HIV, current acute or chronic hepatitis B (hepatitis B surface-antigen positive),hepatitis C, or cirrhosis.12. Recent or ongoing clinically significant gastrointestinal disorder13. Evidence of serious active infection or significant medical or psychiatric illness.

The primary endpoint for this study is the complete cytogenetic response (CCyR) rate at one year after randomization.

Fase III
  DISEÑO DEL ENSAYO:

Si
Si

Si
No

No
No

No
No
  COMPARADOR DEL ENSAYO CONTROLADO:

Si
No

No
No

Si

Centros participantes:


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

9
  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:


50

Para estudios internacionales:


206
412

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


EC Finalizado



EC Finalizado