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

Novartis

Status and phase: Completed; Phase 1

Conditions: Esophageal Cancer; Head & Neck Cancer; Prostate Cancer

Treatments: Drug: panobinostat

Study type: Interventional

Funder types: Industry

Identifiers

NCT00670553

CLBH589CBE01

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

LBH589

Experimental group

Treatment:

Drug: panobinostat