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

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.

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Key information

Conditions

Prostate Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Head & Neck Cancer Head and Neck Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site

Liège, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Panobinostat

Drug

Other names: LBH589

Primary outcomes

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

Time frame: 1 to 28 days

Secondary outcomes

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

Time frame: min 1 month

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: May 2, 2008
Registry last updated: May 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting