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

Phase 1

Completed

• Conditions: Head & Neck Cancer; Prostate Cancer; Esophageal Cancer
• Interventions: Drug: panobinostat

• Registration Number: NCT00670553
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-04-30
• Study First Submitted QC: 2008-05-01
• Study First Posted: 2008-05-02
• Study Start: 2008-09
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-15
• Last Update Posted: 2017-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LBH589	panobinostat	-

Primary Outcome Measures

Name	Time	Method
Establish Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD)	1 to 28 days

Secondary Outcome Measures

Name	Time	Method
Safety profile of oral LBH589 when given in combination with standard Radiotherapy	min 1 month

Trial Locations

Locations (1)

Novartis Investigative Site; 🇧🇪 Liege, Belgium