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

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

This study is ongoing, but not recruiting participants.

Sponsored by:	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

MedlinePlus related topics:

Cancer Lymphoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Phase I Dose-Escalation Study of LBH589 Administered Orally in Adult Patients With Advanced Solid Tumors or Cutaneous T-Cell Lymphoma

Further study details as provided by Novartis:

Primary Outcome Measures:

To determine the maximum-tolerated dose of LBH589

Secondary Outcome Measures:

Safety and tolerability assessed by AEs, SAEs and laboratory values.
To characterize the pharmacokinetic (PK) profile of LBH589
To assess antitumor activity of LBH589

Estimated Enrollment:	18
Study Start Date:	November 2006

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

	Tokyo, Japan

Sponsors and Collaborators

Novartis

Investigators


Study Chair:	Novartis	Novartis

More Information

Study ID Numbers:	CLBH589B1101
First Received:	December 18, 2006
Last Updated:	January 25, 2008
ClinicalTrials.gov Identifier:	NCT00412997
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:

Solid tumor

Cutaneous T-cell lymphoma

Phase I

HDAC inhibitor

Adult patients with advanced solid tumors or cutaneous T-cell lymphoma whose disease has progressed

Study placed in the following topic categories:

Lymphatic Diseases

Mycoses

Sezary syndrome

Immunoproliferative Disorders

Cutaneous T-cell lymphoma

Lymphoma, T-Cell

Sezary Syndrome

Mycosis Fungoides

Lymphoma, Non-Hodgkin

Lymphoproliferative Disorders

Lymphoma

Lymphoma, T-Cell, Cutaneous

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Immune System Diseases

ClinicalTrials.gov processed this record on September 05, 2008