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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00670553

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer Head & Neck Cancer Esophageal Cancer	Drug: panobinostat	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

7 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Sep 1, 2008

Actual Primary Completion Date :

Jan 1, 2010

Actual Study Completion Date :

Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LBH589	Drug: panobinostat Other Names: LBH589

Arm

Intervention/Treatment

Experimental: LBH589

Drug: panobinostat

Other Names:

LBH589

Outcome Measures

Primary Outcome Measures

Establish Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD) [1 to 28 days]

Secondary Outcome Measures

Safety profile of oral LBH589 when given in combination with standard Radiotherapy [min 1 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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