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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Neoplasms
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Panobinostat
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014