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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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00670553
Enrollment
7
Registered
2008-05-02
Start date
2008-09-30
Completion date
2010-01-31
Last updated
2017-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer, Head & Neck Cancer, Prostate Cancer

Keywords

Prostate,, Head & Neck,, Esophageal

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.

Interventions

DRUGpanobinostat

Sponsors

Novartis Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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/

Design outcomes

Primary

MeasureTime frame
Establish Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD)1 to 28 days

Secondary

MeasureTime frame
Safety profile of oral LBH589 when given in combination with standard Radiotherapymin 1 month

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026