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

Novartis

Status and phase: Completed; Phase 1

Conditions: Tumors; Cutaneous T-Cell Lymphoma

Treatments: Drug: LBH589

Study type: Interventional

Funder types: Industry

Identifiers

NCT00412997

CLBH589B1101

Details and patient eligibility

About

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

Enrollment: 14 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

LBH589

Experimental group

Treatment:

Drug: LBH589