Status:
COMPLETED
LBH589 in Adult Patients With Advanced Solid Tumors or Cutaneous T-cell Lymphoma
Lead Sponsor:
Novartis
Conditions:
Tumors
Cutaneous T-Cell Lymphoma
Eligibility:
All Genders
20+ years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00412997
Start Date
November 1 2006
Last Update
November 27 2012
Active Locations (1)
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1
Novartis Investigative Site
Tokyo, Japan