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 Pharmaceuticals7 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer Head & Neck Cancer Esophageal Cancer

Interventions

panobinostatDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Novartis Investigative Site

Liège, Belgium

Outcomes

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

Data from ClinicalTrials.gov

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