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

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00412997

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 I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized 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:

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: LBH589

U.S. FDA Resources

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

More Information

No publications provided

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00412997 History of Changes
Other Study ID Numbers:	CLBH589B1101
Study First Received:	December 18, 2006
Last Updated:	March 16, 2010
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 February 09, 2012