A Dose Finding Study With I.V. Panobinostat (LBH589), Docetaxel, and Prednisone in Patients With Hormone Refractory Prostate Cancer
NCT ID: NCT00663832
Last Updated: 2020-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
44 participants
INTERVENTIONAL
2008-02-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LBH589
LBH589 (i.v. panobinostat)
i.v. LBH589 dose levels: 10, 15, or 20 mg/m2
i.v. docetaxel 75 or 60 mg/m2
oral prednisone 5mg bid.
LBH589 i.v. administered on days 1 and 8 in combination with docetaxel i.v. on day 1 and prednisone p.o 5mg bid every day of a 21-day cycle
Interventions
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LBH589 (i.v. panobinostat)
i.v. LBH589 dose levels: 10, 15, or 20 mg/m2
i.v. docetaxel 75 or 60 mg/m2
oral prednisone 5mg bid.
LBH589 i.v. administered on days 1 and 8 in combination with docetaxel i.v. on day 1 and prednisone p.o 5mg bid every day of a 21-day cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Evidence of disease progression
* Self care, able to perform light work activities
* Willing to use contraception throughout the study and for 12 weeks after study completion
Exclusion Criteria
* Prior radiotherapy within 3 weeks of starting study treatment
* Prior radiopharmaceuticals (strontium, samarium).
* Impaired cardiac function
* Heart disease
* Liver or renal disease with impaired functions.
18 Years
MALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Rockville, Maryland, United States
Novartis Investigative Site
Detroit, Michigan, United States
Novartis Investigative Site
St Louis, Missouri, United States
Novartis Investigative Site
Las Vegas, Nevada, United States
Novartis Investigative Site
New York, New York, United States
Novartis Investigative Site
Durham, North Carolina, United States
Novartis Investigative Site
Portland, Oregon, United States
Novartis Investigative Site
Vancouver, British Columbia, Canada
Novartis Investigative Site
Hamilton, Ontario, Canada
Countries
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Related Links
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Results for CLBH589C2205 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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2007-003315-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLBH589C2205
Identifier Type: -
Identifier Source: org_study_id