LBH589 in Adult Patients With Advanced Solid Tumors or Cutaneous T-cell Lymphoma
- Registration Number
- NCT00412997
- Lead Sponsor
- Novartis
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LBH589 LBH589 -
- Primary Outcome Measures
Name Time Method To determine the maximum-tolerated dose of LBH589 1st cycle
- Secondary Outcome Measures
Name Time Method Safety and tolerability assessed by AEs, SAEs and laboratory values. Every 2 weeks To characterize the pharmacokinetic (PK) profile of LBH589 every 3 cycles To assess antitumor activity of LBH589 every 2 cycles
Trial Locations
- Locations (1)
Novartis Investigative Site
🇯🇵Tokyo, Japan