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

Tumors Clinical Trial

Official title:

A Phase I Dose-escalation Study of LBH589 Administered Orally in Adult Patients With Advanced Solid Tumors or Cutaneous T-cell Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00412997
• Other study ID #: CLBH589B1101
• 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. 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

Related Conditions & MeSH terms

• Cutaneous T-Cell Lymphoma
• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous
• Tumors

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