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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

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: April 30, 2008
Last updated: August 31, 2016
Last verified: August 2016
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.

Condition Intervention Phase
Prostate Cancer
Head & Neck Cancer
Esophageal Cancer
Drug: panobinostat
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Establish Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD) [ Time Frame: 1 to 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety profile of oral LBH589 when given in combination with standard Radiotherapy [ Time Frame: min 1 month ] [ Designated as safety issue: Yes ]

Enrollment: 7
Study Start Date: September 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LBH589 Drug: panobinostat
Other Name: LBH589


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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:

  • 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

  Contacts and Locations
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Please refer to this study by its identifier: NCT00670553

Novartis Investigative Site
Liege, Belgium
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals Identifier: NCT00670553     History of Changes
Other Study ID Numbers: CLBH589CBE01 
Study First Received: April 30, 2008
Last Updated: August 31, 2016
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Novartis:
Head & Neck,

Additional relevant MeSH terms:
Prostatic Neoplasms
Head and Neck Neoplasms
Esophageal Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on October 27, 2016