Back to resultsA 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
Primary Purpose
Prostate Cancer, Head & Neck Cancer, Esophageal Cancer
Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
panobinostat
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate,, Head & Neck,, Esophageal
Eligibility 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
Sites / Locations
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LBH589
Arm Description
Outcomes
Primary Outcome Measures
Establish Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD)
Secondary Outcome Measures
Safety profile of oral LBH589 when given in combination with standard Radiotherapy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00670553
Brief 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
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 Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Head & Neck Cancer, Esophageal Cancer
Keywords
Prostate,, Head & Neck,, Esophageal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LBH589
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
panobinostat
Other Intervention Name(s)
LBH589
Primary Outcome Measure Information:
Title
Establish Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD)
Time Frame
1 to 28 days
Secondary Outcome Measure Information:
Title
Safety profile of oral LBH589 when given in combination with standard Radiotherapy
Time Frame
min 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Liege
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
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
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