A Study to Determine the Absorption, Distribution, Metabo... | NCT00472368

Studies
A Study to Determine the Absorption, Distribution, Metabolism, and Excretion of LBH589

NCT00472368

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

May 1, 2012Estimated

Enrollment

4Actual

Phase

Phase 1

Conditions

Cancer Patients With Advanced Solid Tumors Including Lymphoma or Chronic Hematological Malignancies

Interventions

LBH589

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Jun 2008Actual

Completion Date

Not provided

First Submitted Date

May 10, 2007

First Submission Date that Met QC Criteria

May 10, 2007

First Posted Date

May 11, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2012

Last Update Posted Date

May 1, 2012Estimated

Description Module

Brief Summary

This single center study will help determine the absorption, metabolism, and excretion of LBH589 and to assess the safety and efficacy of LBH589 in advanced cancer patients for whom no standard therapy exists.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Label	Type	Description	Intervention Names
LBH589	Experimental		Drug: LBH589

Name	Type	Description	Arm Group Labels	Other Names
LBH589	Drug		LBH589	Panobinostat

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rates and routes of excretion of LBH589 and its metabolites in urine and feces following administration of a single oral dose of [14C] LBH589	oral dose of [14C] LBH589	during the first 8 days on study

Secondary Outcomes

Measure	Description	Time Frame
Safety Efficacy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria

Histologically or cytologically confirmed cancer patients including solid tumors, lymphoma, or chronic hematological malignancies with progression on prior standard therapies.
Eastern Cooperative Oncology Group (ECOG) Performance Status of < 2
Normal renal and hepatic function

Exclusion criteria

Patients with central nervous system (CNS) involvement or brain metastases
Patients who have received chemotherapy, any investigational drug, undergone major surgery, or received wide field radiotherapy less than 4 weeks ago
Patients with congenital long QT syndrome or uncontrolled hypertension
Patients with a myocardial infarction or unstable angina within 6 months
Congestive heart failure
Impairment of gastrointestinal (GI) function
Use of any anti-cancer therapy
Female patients who are pregnant or breast feeding

Other protocol inclusion/exclusion criteria may apply.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Buffalo	New York	14263	United States

Condition Browse Module

MeSH Terms

ID	Term
D008223	Lymphoma

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077767	Panobinostat

Ancestor Terms

ID	Term
D006877	Hydroxamic Acids
D006898	Hydroxylamines
D000588	Amines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided