Este estudio evaluará la seguridad y eficacia de LBH489B en pacientes adultos con linfoma T cutáneo refractario.
Elegibilidad
Edad mínima: 18 YearsSexo: ALL
Criterios de inclusión
Written informed consent obtained prior to any screening procedures
Age ≥ 18 years old
Patients with biopsy-confirmed stages IB-IVA mycosis fungoides or Sézary syndrome. Patients with SS who have bone marrow involvement are also eligible.
Patients must have received at least two prior treatment regimens at least one of which was a systemic therapy regimen. Systemic regimens include oral bexarotene, PUVA, photophoresis, oral corticosteroids, total skin electron bean therapy, chemotherapy such as methotrexate, and interferon. Topical steroids alone are not considered as a treatment regimen.
Patients must have had disease progression on or following their most recent treatment regimen or an inadequate response to their most recent treatment regimen.
Patients will be accrued to one of two groups: Patients previously treated with oral bexarotene and patients who have not had prior oral bexarotene treatment.
Criterios de exclusión
Prior treatment with an HDAC inhibitor.
Patients with visceral disease including CNS involvement (i.e. stage IVB CTCL). Note; Patients with SS who have bone marrow involvement are eligible.
Impaired cardiac function
Concomitant use of drugs with a risk of causing torsades de pointes
Patients who have received chemotherapy or any investigational drug or undergone major surgery \< 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy
Less than 3 months since prior electron beam therapy
Female patients who are pregnant or breast feeding, or patients of reproductive potential not using an effective method of birth control, and male patients whose sexual partners are women of childbearing potential not using effective birth control
Uncontrolled hypertension
Concomitant use of any anti-cancer therapy or radiation therapy. Low potency topical steroid use is permitted. Topical bexarotene use is prohibited during the trial
Concomitant use of CYP3A4/5 inhibitors.
Patients with unresolved diarrhea \> CTCAE grade 1
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LBH589
Other concurrent severe and/or uncontrolled medical conditions
Patients who would need to receive valproic acid for any reason during the study or ≤ 5 days prior to starting study drug.
Intervenciones
drug
Panobinostat
Ubicaciones
Novartis Investigative Site
CABA, Buenos Aires, Argentina
Novartis Investigative Site
Buenos Aires, Argentina
Patrocinadores
PrincipalNovartis Pharmaceuticals
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