Hemotrial Un proyecto de SEHH

Ensayo clínico

Ensayo aleatorizado, abierto, multicéntrico, en 2 fases, con grupos paralelos, para evaluar la eficacia, seguridad y tolerabilidad de AZD1152 sólo y en combinación con dosis bajas de arabinósido de citosina (DBAraC), comparado con DBAraC sólo, en pacientes de edad mayor o igual a 60 años con leucemia mieloide aguda (LMA) de nuevo diagnostico, que se han considerado no candidatos a quimioterapia intensiva de inducción.A randomised, open-label, multi-centre, 2-stage, parallel group study to assess the efficacy, safety and tolerability of AZD1152 alone and in combination with low dose cytosine arabinoside (LDAC) in comparison with LDAC alone in patients aged greater than or equal to 60 with newly diagnosed acute myeloid leukaemia (AML) who are considered unsuitable to receive intensive induction chemotherapy regimens

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Resumen

2017-03-15 04:10:52
2009-010114-30
D1531C00009
Ensayo aleatorizado, abierto, multicéntrico, en 2 fases, con grupos paralelos, para evaluar la eficacia, seguridad y tolerabilidad de AZD1152 sólo y en combinación con dosis bajas de arabinósido de citosina (DBAraC), comparado con DBAraC sólo, en pacientes de edad mayor o igual a 60 años con leucemia mieloide aguda (LMA) de nuevo diagnostico, que se han considerado no candidatos a quimioterapia intensiva de inducción.A randomised, open-label, multi-centre, 2-stage, parallel group study to assess the efficacy, safety and tolerability of AZD1152 alone and in combination with low dose cytosine arabinoside (LDAC) in comparison with LDAC alone in patients aged greater than or equal to 60 with newly diagnosed acute myeloid leukaemia (AML) who are considered unsuitable to receive intensive induction chemotherapy regimens
D1531C00009

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
AstraZeneca AB Sweden

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test Cytarabine 20 mg/ml Injection
Mayne Pharma plc AZD1152 100mg Lyophile
AZD1152 Powder and solvent for solution for infusion
Intravenous use

Detalles del Fármaco (Principio Activo):

AZD1152 Hydrate AZD1152 Pure

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
Low dose cytosine arabinoside
Solution for injection
Subcutaneous use

Detalles del Fármaco (Principio Activo):

cytosine arabin

Concentración del fármaco:

mg/ml milligram equal

20

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



Leucemia Aguda

Leucemia mieloide agudaAcute Myeloid Leukemia


Stage 1: To make a preliminary assessment of the relative efficacy of AZD1152 monotherapy compared to LDAC by assessment of OCRRThe outcome of Stage 1 will inform the decision as to whether the trial should continue to Stage 2. Stage 2:to determine the relative efficacy of AZD1152, both alone, and in combination with LDAC compared to LDAC alone by assessment of OCRR

Stage 1: AZD1152 monotherapy compared to LDAC 1. To assess the efficacy by assessment of Overall Survival (OS), Duration of Response (DoR) and Time to Complete Response (TTCR) 2. To assess the effects on a) patients health related quality of life (HRQoL) and disease-related symptoms b) the number of key healthcare cost-generating events c) the requirement for key healthcare interventions 3. Safety/tolerability Stage 2: AZD1152, alone and in combination with LDAC, compared to LDAC alone1. To determine the efficacy by assessment of OS, DoR and TTCR 2. To assess the effects on a) HRQoL and disease-related symptoms b) the number of key healthcare cost-generating events c) the requirement for key healthcare interventions 3. Safety/tolerability Stage 1 and 2: To determine the population PK of AZD1152 and AZD1152 hQPA, and to assess the relationship between PK and measures of PD response, efficacy and AEs in patients with AML

Si

Biomarker Sub-study: Included in the main protocolObjectives of the biomarker sub-study: To predict how people will respond to treatment with the study drug(s) AZD1152 and LDAC used alone, and AZD1152 and LDAC used in combination in the study and to

1. Provision of written informed consent prior to any study specific procedures2. Newly diagnosed male or female patients aged greater than or equal to 60 years3. De Novo (primary) or Secondary AML4. Not eligible for intensive induction chemotherapy because of medical, social or psychological reasons5. World Health Organisation (WHO) performance status 0-3 (WHO performance status 3 is only acceptable if solely attributed to the underlying leukaemia)6. Serum bilirubin lower than or equal to 1.5 x Upper Limit of Normal (ULN) unless considered due to leukaemic organ involvement (Gilbert's or related syndrome allowed)7. Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) lower than or equal to 2.5 x ULN, unless considered due to leukaemic organ involvement8. Serum creatinine lower than or equal to 1.5 x ULN or 24-hour creatinine clearance > 50 mL/min (measured or calculated by Cockcroft-Gault)9. Likely ability to complete 3 cycles (12 weeks) of treatment10. Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients.

1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site and/or agents for AstraZeneca)2. Previous randomisation of treatment in the present study3. Participation in another clinical study in which an investigational product was received within 14 days before the first dose in this study, or at any time if the patient has not recovered from side-effects associated with that investigational product (to CTCAE Grade 1 or baseline, except alopecia)4. Administration of LDAC is clinically contraindicated5. Patients with AML of FAB M3 classification Acute Promyelocytic Leukaemia (APL)6. Patients with blast crisis of chronic myeloid leukaemia7. Mean QTc interval greater than or equal to 470ms calculated from 3 ECGs using Fridericia's or Bazett's Correction8. Any chemotherapy e.g. for prior MDS, or radiotherapy within 14 days prior to starting the study (not including palliative radiotherapy at local sites)9. Persistent, chronic, clinically significant toxicities, from any prior anti-cancer therapy greater than CTCAE Grade 1 (except alopecia)10. Patients with symptomatic clinically defined central nervous system (CNS) disease (asymptomatic patients are eligible if symptom free for > 10 days)11. Uncontrolled intercurrent illness including, but not limited to active infection, symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations which would limit compliance with protocol requirements12. Major surgery within 4 weeks prior to entry into the study (excluding the placement of vascular access) that involved general anaesthesia or respiratory assistance13. Patients with documented cases of human immunodeficiency virus (HIV) or hepatitis B or C14. Female patients who are breast feeding, or patients of reproductive potential not employing an effective method of birth control15. History of hypersensitivity to active or inactive excipients of any study medication (AZD1152 or LDAC)

Overall Complete Response Rate (OCRR), defined as the proportion of patients achieving a Complete Remission (CR) or confirmed CRi (complete remission with incomplete recovery of neutrophils or platelets sustained at 2 consecutive assessments)

Fase II
  DISEÑO DEL ENSAYO:

Si
Si

Si
No

No
Si

No
No
  COMPARADOR DEL ENSAYO CONTROLADO:

Si
No

No
Si

No

Centros participantes:


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

3
0
  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:


4

Para estudios internacionales:


150
420

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


EC Finalizado



EC Finalizado