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NCT00670553 Clinical Trial

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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00670553
Other study ID # CLBH589CBE01
Secondary ID
Status Completed
Phase Phase 1
First received April 30, 2008
Last updated May 15, 2017
Start date September 2008
Est. completion date January 2010

Study information
Verified date May 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 7
Est. completion date January 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• panobinostat

Locations
Country Name City State
Belgium Novartis Investigative Site Liege

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Establish Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD) 1 to 28 days
Secondary Safety profile of oral LBH589 when given in combination with standard Radiotherapy min 1 month
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