NCT00670553

Brief Summary

The purpose of this study is to assess the feasibility of combined administration of different LBH589 dosages with radiotherapy in order to establish the dosage to be evaluated in future studies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for phase_1 prostate-cancer

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_1 prostate-cancer

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

First Submitted

Initial submission to the registry

April 30, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 2, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

1.3 years

First QC Date

April 30, 2008

Last Update Submit

May 15, 2017

Conditions

Prostate CancerHead & Neck CancerEsophageal Cancer

Keywords

Prostate,Head & Neck,Esophageal

Outcome Measures

Primary Outcomes (1)

  • Establish Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD)

    1 to 28 days

Secondary Outcomes (1)

  • Safety profile of oral LBH589 when given in combination with standard Radiotherapy

    min 1 month

Study Arms (1)

LBH589

EXPERIMENTAL
Drug: panobinostat

Interventions

panobinostatDRUG
Also known as: LBH589
LBH589

Eligibility Criteria

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

You may qualify if:

  • Patients with age ≥18 years
  • Confirmed diagnosis of prostate cancer, SCC esophageal cancer or head \& neck cancer
  • No evidence of distant spread of the disease

You may not qualify if:

  • Patients who have severe and/or uncontrolled medical conditions
  • Female patients who are pregnant or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Liège, Belgium

Location

MeSH Terms

Conditions

Prostatic NeoplasmsHead and Neck NeoplasmsEsophageal Neoplasms

Interventions

Panobinostat

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal 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

April 30, 2008

First Posted

May 2, 2008

Study Start

September 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

May 17, 2017

Record last verified: 2017-05

Locations

BE(1)