Hemotrial Un proyecto de SEHH

Ensayo clínico

Estudio Fase II de Panobinostat oral, en pacientes adultos con Linfoma de Hodgkin clásico refractario/en recaida, después de fallo a dosis altas de quimioterapia con transfusión autóloga de células madre y un régimen que contiene gemcitabina o vinorelbina o vinblastina

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Estudio Fase II de Panobinostat oral, en pacientes adultos con Linfoma de Hodgkin clásico refractario/en recaida, después de fallo a dosis altas de quimioterapia con transfusión autóloga de células madre y un régimen que contiene gemcitabina o vinorelbina o vinblastina


Resumen

2017-03-15 04:08:20
2008-003016-35
CLBH589E2214
Estudio Fase II de Panobinostat oral, en pacientes adultos con Linfoma de Hodgkin clásico refractario/en recaida, después de fallo a dosis altas de quimioterapia con transfusión autóloga de células madre y un régimen que contiene gemcitabina o vinorelbina o vinblastina
CLBH589E2214

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
LBH589E Capsule, hard
Oral use

Detalles del Fármaco (Principio Activo):

LBH589E

Concentración del fármaco:

mg milligram(s) equal

5
LBH589E

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


Recaida

Linfomas y otros Síndromes Linfoproliferativos

Linfoma de Hodgkin clásico refractario/en recaída


To determine the objective response rate to therapy with oralpanobinostat in patients with refractory/relapsed classical HL usingmodified response criteria for malignant lymphoma (see Post-textsupplement 1).

? To determine response rate based on central review of CT scan/MRI? To assess the time to response? To assess the duration of response? To evaluate progression-free survival, PFS rate at 6 month and 8month? To assess the safety and tolerability of panobinostat treatment? To assess overall survival? To characterize the PK of panobinostat, including the parent drugand any potential metabolite/s when feasible in at least 15consenting patients with HL

No


1. Patient age is ? 18 years2. Patient has an Eastern Cooperative Oncology Group (ECOG)performance status of ? 23. Patient has a history of classical HL (i.e. Nodular sclerosing, Mixedcellularity,Lymphocyte-rich, Lymphocyte depleted)4. Patient has progressive disease after receiving high dosechemotherapy with AHSCT.5. Patient has progressive disease on or after therapy with agemcitabine- or vinorelbine- or vinblastine-containing regimen, afterfirst relapse.Note: If last therapy was more than ? 18 months ago, then a biopsyshould be performed to confirm diagnosis.6. Patient has at least one site of measurable nodal disease at baseline? 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan(MRI is allowed only if CT scan can not be performed). See Posttextsupplement 1.Note: Patients with bone marrow involvement are eligible, but thiscriteria alone should not be used for disease measurement.7. Patient has the following laboratory values (labs may be repeated, ifneeded, to obtain acceptable values before screen fail):? Absolute neutrophil count (ANC) ? 1.5 x 10 9/L [SI units 1.5 x109/L]? Platelet count ? 75 x 109/L? Serum potassium, magnesium, phosphorus, sodium, total calcium(corrected for serum albumin) or ionized calcium within normallimits (WNL) for the institutionNote: Potassium, calcium, magnesium, sodium, and/or phosphorussupplements may be given to correct values that are

1. Patient has a history of prior treatment with a DAC inhibitor includingpanobinostat2. Patient will need valproic acid for any medical condition during thestudy or within 5 days prior to the first panobinostat treatment3. Patient has been treated with monoclonal antibody therapy (e.g.,rituximab or anti CD-30 antibody, etc.) within 4 weeks of start ofstudy treatment4. Patient has received chemotherapy or any investigational drug orundergone major surgery ? 2 weeks prior to starting study drug orwhose side effects of such therapy have not resolved to ? grade 15. Patient has been treated with > 5 prior systemic lines of treatment(see Post-text supplement 2 for definitions and examples)6. Patient has received prior radiation therapy ? 4 weeks or limited fieldradiotherapy ? 2 weeks prior to start of study treatment or whoseside effects of such therapy have not resolved to ? grade 17. Patient is using any anti-cancer therapy concomitantly8. Patient has been treated with allogeneic hematopoietic stem celltransplant who has received immunosuppressive therapy within 90days prior to start of screening and/or have ? Grade 2 graft versus host disease (GvHD).9. Patient has a history of another primary malignancy ? 3 years beforestudy entry, with the exception of non-melanoma skin cancer, andcarcinoma in situ of uterine cervix10. Patient has a history of CNS involvement with lymphoma11. Patient has impaired cardiac function including any of the following:? Complete left bundle branch block or use of a permanent cardiacpacemaker, congenital long QT syndrome, history or presence ofventricular tachyarrhythmias, clinically significant restingbradycardia (<50 beats per minute), QTcF > 450 msec onscreening ECG, or right bundle branch block + left anteriorhemiblock (bifascicular block)? Presence of unstable atrial fibrillation (ventricular heart rate >100bpm). Patients with stable atrial fibrillation are allowed in the studyprovided they do not meet the other cardiac exclusion criteria? Previous history angina pectoris or acute MI within 6 months? Congestive heart failure (New York Heart Association functionalclassification III-IV)12. Patient has any other clinically significant heart disease (e.g.,uncontrolled hypertension)13. Patient has an impairment of gastrointestinal (GI) function or GIdisease that may significantly alter the absorption of panobinostat(e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea,malabsorption syndrome, obstruction, or stomach and/or small bowelresection)14. Patient has unresolved diarrhea ? grade 215. Patient has any other concurrent severe and/or uncontrolled medicalcondition(s) (e.g., uncontrolled diabetes mellitus, active oruncontrolled infection, chronic obstructive or chronic restrictivepulmonary disease including dyspnoea at rest from any cause) thatcould cause unacceptable safety risks or compromise compliancewith the protocol16. Patient has a known history of HIV seropositivity (screening HIVtesting is not required)17. Patient has active bleeding diathesis or is currently being treated withtherapeutic doses of sodium warfarin (Coumadin®) or other vitaminK active agentsNote: mini-dose of Coumadin® (e.g., 1 mg/day) or anti-coagulantagents given to maintain intravenous line patency, as well asunfractionated or low molecular weight heparin therapy is permitted.18. Patient is using medications that have a relative risk of prolongingthe QT interval or of inducing Torsade de Pointes, where suchtreatment cannot be discontinued or switched to a differentmedication prior to starting study drug19. Women who are pregnant or breast feeding or women ofchildbearing potential (WOCBP) not willing to use a double methodof contraception during the study and 3 months after the end oftreatment. One of these methods of contraception must be a barriermethod. WOCBP are defined as sexually mature women who havenot undergone a hysterectomy or who have not been naturallypostmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months).WOCBP must have a negative serum pregnancy test at baseline.20. Male patient whose sexual partner(s) are WOCBP who are notwilling to use a double method of contraception, one of whichincludes a condom, during the study and for 3 months after the endof treatment

CT scan to assess the response rate and for monitoring for progression safetypharmacokinetic parameters: Cmax, Tmax, and AUC0-24Exploratory FDG-PET scan response and exploratory biomarkers

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:

1
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:


6

Para estudios internacionales:


56
102

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


EC Finalizado



EC Finalizado

Inicial