Status:
COMPLETED
A Dose Finding Study With I.V. Panobinostat (LBH589), Docetaxel, and Prednisone in Patients With Hormone Refractory Prostate Cancer
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
This Phase Ib dose escalation study is designed to characterize the safety, tolerability and preliminary efficacy of i.v. panobinostat (LBH589) in combination with docetaxel and prednisone in the 1st ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- HRPC patients
- 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:
- History of other cancers not curatively treated with no evidence of disease for more than 5 years.
- 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.
- Other protocol-defined inclusion/exclusion criteria may apply
Exclusion
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00663832
Start Date
February 1 2008
Last Update
December 19 2020
Active Locations (9)
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1
Novartis Investigative Site
Rockville, Maryland, United States, 20850
2
Novartis Investigative Site
Detroit, Michigan, United States, 48201
3
Novartis Investigative Site
St Louis, Missouri, United States, 63110
4
Novartis Investigative Site
Las Vegas, Nevada, United States, 89135