ClinicalTrials.gg
Sign In
CompletedNCT00670553Updated May 17, 2017

A Phase I Study of LBH589 (Panobinostat) in Combination With External Beam Radiotherapy for the Treatment of Prostate Cancer, Esophageal Cancer and Head and Neck Cancer

A Phase 1 interventional study of panobinostat in Prostate Cancer, Head & Neck Cancer and Esophageal Cancer, sponsored by Novartis Pharmaceuticals. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-17.

Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Prostate Cancer
  • Head & Neck Cancer
  • Esophageal Cancer

Keywords

  • Prostate,
  • Head & Neck,
  • Esophageal
03

In context

Prostatic Neoplasms

6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.

This study's enrollment of 7 is below the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,711 studies on the registry; 218 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 435 (75%) have results posted.

Browse Novartis Pharmaceuticals studies →All Novartis studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion criteria:

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

Other protocol-defined inclusion/exclusion criteria may apply

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    LBH589

    Drug: panobinostat

Interventions

06

What researchers measure

Primary outcomes

  1. Establish Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD)

    Time frame: 1 to 28 days

Secondary outcomes

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

    Time frame: min 1 month

07

Study locations

1 site
  • Novartis Investigative Site
    Liège, Belgium
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2008, a primary completion of Jan 2010 and a completion of Jan 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 30, 2008
First posted
May 2, 2008
Start
Sep 2008
Primary completionActual
Jan 2010
CompletionActual
Jan 2010
Last update
May 17, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00670553
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
May 2, 2008
Start date
Sep 2008
Primary completion
Jan 2010
Completion
Jan 2010
Last update
May 17, 2017

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Panobinostat

Other studies in this condition

Prostatic Neoplasms →

Other studies from this sponsor

Novartis Pharmaceuticals →

Start the discussion