LBH589 in Adult Patients With Advanced Solid Tumors or Cutaneous T-cell Lymphoma

A Phase I Dose-escalation Study of LBH589 Administered Orally in Adult Patients With Advanced Solid Tumors or Cutaneous T-cell Lymphoma

The phase I study will evaluate the safety, efficacy and pharmacokinetics of LBH589B in adult patients with advanced solid tumors or Cutaneous T-cell lymphoma

Inclusion Criteria:

• Patients with either a) histologically-confirmed, advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists, or b) cytopathologically confirmed cutaneous T-cell lymphoma (CTCL) whose disease has progressed despite standard therapy or for whom no standard therapy exists. Inclusion is irrespective of stage of disease or extent of prior therapy.
• World Health Organization (WHO) Performance Status of ≤ 2
• Patients must have the adequate laboratory values

Exclusion Criteria:

• Patients with a history of primary CNS tumors
• Patients with any history of brain metastases
• Patients with any peripheral neuropathy ≥ CTCAE grade 2
• Patients with unresolved diarrhea ≥ CTCAE grade 2
• Impairment of cardiac function
• Impairment of gastrointestinal (GI) function or GI disease
• Liver or renal disease

Other protocol-defined inclusion/exclusion criteria may apply