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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Panobinostat

Criteria

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