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
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Prostate Cancer, Head & Neck Cancer, Esophageal Cancer
Both
Prostate Cancer, Head & Neck Cancer, Esophageal Cancer
Trial Information
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
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Establish Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD)
Outcome Time Frame:
1 to 28 days
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
Belgium: Federal Agency for Medicinal Products and Health Products
Study ID:
CLBH589CBE01
NCT ID:
NCT00670553
Start Date:
September 2008
Completion Date:
Related Keywords:
- Prostate Cancer
- Head & Neck Cancer
- Esophageal Cancer
- Prostate,
- Head & Neck,
- Esophageal
- Esophageal Diseases
- Esophageal Neoplasms
- Head and Neck Neoplasms
- Prostatic Neoplasms
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