NCT00472368

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 11, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Last Updated

May 1, 2012

Status Verified

April 1, 2012

Enrollment Period

1.1 years

First QC Date

May 10, 2007

Last Update Submit

April 27, 2012

Conditions

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

Keywords

Advanced cancerlymphomachronic hematological malignanciesadult

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Safety Efficacy

Study Arms (1)

LBH589

EXPERIMENTAL
Drug: LBH589

Interventions

LBH589DRUG
Also known as: Panobinostat
LBH589

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Lymphoma

Interventions

Panobinostat

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Hydroxamic AcidsHydroxylaminesAminesOrganic ChemicalsHydroxy AcidsCarboxylic AcidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2007

First Posted

May 11, 2007

Study Start

May 1, 2007

Primary Completion

June 1, 2008

Last Updated

May 1, 2012

Record last verified: 2012-04

Locations

US(1)