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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00412997
First received: December 18, 2006
Last updated: November 26, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention Phase
Tumors
Cutaneous T-Cell Lymphoma
Drug: LBH589
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Dose-escalation Study of LBH589 Administered Orally in Adult Patients With Advanced Solid Tumors or Cutaneous T-cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • To determine the maximum-tolerated dose of LBH589 [ Time Frame: 1st cycle ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety and tolerability assessed by AEs, SAEs and laboratory values. [ Time Frame: Every 2 weeks ] [ Designated as safety issue: Yes ]
  • To characterize the pharmacokinetic (PK) profile of LBH589 [ Time Frame: every 3 cycles ] [ Designated as safety issue: No ]
  • To assess antitumor activity of LBH589 [ Time Frame: every 2 cycles ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: November 2006
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LBH589 Drug: LBH589
Other Name: panobinostat

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00412997

Locations
Japan
Novartis Investigative Site
Tokyo, Japan
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00412997     History of Changes
Other Study ID Numbers: CLBH589B1101
Study First Received: December 18, 2006
Last Updated: November 26, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:
advanced solid tumor
Cutaneous T-cell lymphoma
Phase I
HDAC inhibitor
Adult patients

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on April 15, 2014