Hemotrial Un proyecto de SEHH

Ensayo clínico

Estudio Fase II de Panobinostat oral en monoterapia, en pacientes con leucemia mieloide aguda (LMA) refractaria de novo o refractaria secundaria.

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Resumen

2017-03-15 04:08:15
2008-002983-32
CLBH589B2213
Estudio Fase II de Panobinostat oral en monoterapia, en pacientes con leucemia mieloide aguda (LMA) refractaria de novo o refractaria secundaria.
CLBH589B2213

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
Novartis Farmacéutica S.A. Spain

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test
panobinostat
LBH589 Capsule, hard
Oral use

Detalles del Fármaco (Principio Activo):
LBH589

Concentración del fármaco:
mg milligram(s) equal

5

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
panobinostat
LBH589 Capsule, hard
Oral use

Detalles del Fármaco (Principio Activo):
LBH589

Concentración del fármaco:
mg milligram(s) 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

Pacientes con leucemia mieloide aguda (LMA) refractaria de novo o refractaria secundaria

To determine the complete remission rate (CRR, defined as CR + CRi).

? To assess partial response. ? To assess time to and duration of remission.? To assess overall and event-free survival.? To assess safety and tolerability.

No


5.1.1 Stratum A Specific Inclusion Criterion1. Refractory AML with confirmed initial diagnosis of de novo AML (excluding APL)5.1.2 Stratum B Specific Inclusion Criterion1. Refractory AML with confirmed initial diagnosis of AML (excluding APL) secondary to AHD or MDS with either condition precedent to AML (MDS/AHD) having received either no treatment or conventional care regimens (CCR), including best supportive care (BSC), low dose cytarabine, intensive chemotherapy, hypomethylating agents (azacitidine, decitabine), or other therapies (e.g. lenalidomide)5.1.3 Stratum A or B General Inclusion Criteria1. Written informed consent prior to study-specific screening procedures2. Age ≥ 18 years old3. Refractory AML, defined as no response (CR1) to initial induction treatment or CR1 lasting <12 months and in first relapse4. Eastern Cooperative Group (ECOG) performance status ≤ 2 5. Laboratory values as follows:? Electrolyte panel WNL for the institution (potassium and magnesium values < lower limit of normal must be corrected to WNL prior to dosing)? Total calsium (corrected for albumin) or ionized calcium WNL for the institution? AST/SGOT and ALT/SGPT ≤ 2.5 x ULN (NCI CTCAE Gr 1)? Serum creatinine ≤ 1.5 x ULN (NCI CTCAE Gr 1)? Serum bilirubin ≤ 1.5 x ULN unless attributed to underlying disease (NCI CTCAE Gr 1)? INR ≤ 1.5 and PTT WNL. Patients receiving anticoagulation therapy (e.g. coumadin, heparin) are eligible provided anticoagulation therapy can be discontinued or changed to parenteral medications while the platelet count is less than 50,000/mm3? Negative serum pregnancy test (within 7 days of first dose)? Negative urine pregnancy test immediately prior to first dose? Clinically euthyroid (hypothyroidism corrected with supplementation is permitted)6. Patient has received remission induction therapy (± consolidation) for AML, including chemotherapy and/or HSCT.7. Previous chemotherapy for AML has stopped at least 2 weeks or at least five half lives, whichever is longer, before the first dose of study drug8. Patient has recovered from toxicity of previous antileukemic therapy, including Grade ≤ 1 non-hematologic toxicity prior to the first dose of study drug

5.1.4 Stratum A or B General Exclusion Criteria1. Patients with initial diagnosis of AML secondary to ionizing radiation/cytotoxic therapy (e.g. alkylating agents) for previous malignancy2. Patients requiring valproic acid for any medical condition during the study or within 5 days prior to the first dose of study drug3. Clinical symptoms suggesting CNS leukemia (patients with neurologic symptoms must undergo lumbar puncture and a CT scan or MRI of the brain to exclude CNS involvement4. Patients receiving supportive therapy related to complications of allogeneic transplantation, including infections or GVH directed therapy5. Patients who have received either hydroxyurea or glucocorticosteroids for prevention of leukostasis less than 24 hours before the fist dose of study drug6. Patients with another malignancy (with the exception of prior MDS in patients with initial diagnosis of AML secondary to MDS/AHD) unless disease-free for at least 3 years following the completion of curative intent therapy. Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasm regardless of the disease-free duration, are eligible if definitive treatment for the condition has been completed.7. Patients with impaired cardiac function including any of the following:? Complete left bundle branch block or use of a permanent cardiac pacemaker, congenital long QT syndrome, history or presence of ventricular tachyarrhythmias, clinically significant resting bradycardia (<50 beats per minute), QTcF ≥ 450 ms on screening ECG, or right bundle branch block + left anterior hemiblock (bifascicular block)? LVEF< lower limit of institutional normal, as assessed by ECHO or MUGA? Presence of unstable atrial fibrillation (ventricular response rate >100 bpm). Patients with stable atrial fibrillation are eligible provided they do not meet the other cardiac exclusion criteria? Angina pectoris or acute MI within 6 months? Other clinically significant heart disease (e.g. uncontrolled hypertension or history of poor compliance with an antihypertensive regimen)8. Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes mellitus, chronic obstructive or chronic restrictive pulmonary disease including dyspnea at rest from any cause) or history of serious organ dysfunction or disease involving the heart, kidney or liver and/or known seropositive HIV (HIV screening testing is not required) 9. Patient has an impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral panobinostat (e.g., ulcerative disease, uncontrolled vomiting, grade > 1 diarrhea, malabsorption syndrome, obstruction, or stomach and/or small bowel resection)10. Psychiatric disorder that interferes with ability to understand the study and give informed consent, and/or would impact study participation or follow-up11. Concurrent use of medications that have a relative risk of prolonging the QT interval or of inducing Torsade de Pointes, if such treatment cannot be discontinued or switched to a different medication prior to the first dose of study drug12. Female patients who are pregnant or breast-feeding or patients of childbearing potential (WOCBP) not willing to use a double barrier method of contraception during the study and for 3 months following the last dose of study drug. WOCBP are defined as sexually mature women who have not undergone a hysterectomy or surgical sterilization or who have not been postmenopausal for at least 12 consecutive months (i.e. has had menses any time in the preceding 12 consecutive months).13. Male patients whose sexual partner(s) are women of childbearing potential (WOCBP) who are not willing to use a double barrier method of contraception, one of which includes a condom, during the study and for 3 months after the end of treatment.14. Patient is receiving concurrent immuno, gene, or biologic therapy15. Patient is unable to swallow capsules

? Complete remission rate (CRR), defined as the number of CR/CRi in patients with refractory de novo AML (Stratum A) or refractory secondary AML (Stratum B). CR and CRi will be assessed by the Investigator according to the response criteria for AML (Cheson, et al 2003) as implemented in the Post-test supplement 1.

Fase II
  DISEÑO DEL ENSAYO:

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
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:

50
164

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


 Por Determinar



En Marcha