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.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00670553
First received: April 30, 2008
Last updated: March 17, 2011
Last verified: March 2011
  Purpose

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: Allocation: Non-Randomized
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
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LBH589 Drug: panobinostat
Other Name: LBH589

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00670553

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

No publications provided

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00670553     History of Changes
Other Study ID Numbers: CLBH589CBE01
Study First Received: April 30, 2008
Last Updated: March 17, 2011
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Novartis:
Prostate,
Head & Neck,
Esophageal

Additional relevant MeSH terms:
Esophageal Neoplasms
Head and Neck Neoplasms
Prostatic Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 22, 2014