NCT00412997

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

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

Enrollment
14

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

November 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Last Updated

November 27, 2012

Status Verified

November 1, 2012

Enrollment Period

1.5 years

First QC Date

December 18, 2006

Last Update Submit

November 26, 2012

Conditions

TumorsCutaneous T-Cell Lymphoma

Keywords

advanced solid tumorCutaneous T-cell lymphomaPhase IHDAC inhibitorAdult patients

Outcome Measures

Primary Outcomes (1)

  • To determine the maximum-tolerated dose of LBH589

    1st cycle

Secondary Outcomes (3)

  • Safety and tolerability assessed by AEs, SAEs and laboratory values.

    Every 2 weeks

  • To characterize the pharmacokinetic (PK) profile of LBH589

    every 3 cycles

  • To assess antitumor activity of LBH589

    every 2 cycles

Study Arms (1)

LBH589

EXPERIMENTAL
Drug: LBH589

Interventions

LBH589DRUG
Also known as: panobinostat
LBH589

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • World Health Organization (WHO) Performance Status of ≤ 2
  • Patients must have the adequate laboratory values

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Tokyo, Japan

Location

MeSH Terms

Conditions

NeoplasmsLymphoma, T-Cell, Cutaneous

Interventions

Panobinostat

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeLymphoproliferative 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

December 18, 2006

First Posted

December 19, 2006

Study Start

November 1, 2006

Primary Completion

May 1, 2008

Last Updated

November 27, 2012

Record last verified: 2012-11

Locations

JP(1)