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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00412997
Other study ID # CLBH589B1101
Secondary ID
Status Completed
Phase Phase 1
First received December 18, 2006
Last updated November 26, 2012
Start date November 2006

Study information

Verified date November 2012
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date
Est. primary completion date May 2008
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
LBH589


Locations

Country Name City State
Japan Novartis Investigative Site Tokyo

Sponsors (1)

Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary To determine the maximum-tolerated dose of LBH589 1st cycle Yes
Secondary Safety and tolerability assessed by AEs, SAEs and laboratory values. Every 2 weeks Yes
Secondary To characterize the pharmacokinetic (PK) profile of LBH589 every 3 cycles No
Secondary To assess antitumor activity of LBH589 every 2 cycles No
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