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

NCT ID: NCT00412997

Last Updated: 2012-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Brief Summary

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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

Detailed Description

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Conditions

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Tumors Cutaneous T-Cell Lymphoma

Keywords

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advanced solid tumor Cutaneous T-cell lymphoma Phase I HDAC inhibitor Adult patients

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LBH589

Group Type EXPERIMENTAL

LBH589

Intervention Type DRUG

Interventions

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LBH589

Intervention Type DRUG

Other Intervention Names

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panobinostat

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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CLBH589B1101

Identifier Type: -

Identifier Source: org_study_id