Status:
COMPLETED
Study to Evaluate Panobinostat (DACi) Pharmacokinetics and Safety in Solid Tumors and Varying Renal Function
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Panobinostat (LBH589) is a deacetylase inhibitor (DACi) which belongs to a structurally novel cinnamic hydroxamic acid class of compounds. It is one of the most potent class I/II pan-DAC inhibitor (pa...
Eligibility Criteria
Inclusion
- Patient has documented diagnosis of advanced solid tumor for which no standard systemic therapy exists
- Patient has normal or abnormal renal organ function
- Patient has provided written informed consent prior to any screening procedures
Exclusion
- Patient needing valproic acid for any medical condition during the study or within 5 days prior to the first panobinostat dose
- Patient received prior treatment with DAC inhibitors including panobinostat
- Patient requiring dialysis
- Patient requiring diuretics unless patient is taking potassium sparring diuretics
- Patient has acute renal failure, history of transplant, ESRD (however acceptable severe renal impaired group)
- Female patient who is pregnant or breast feeding or with childbearing potential and not willing to use a double method of contraception up to 3 months after the end of study treatment. Male patient who is not willing to use a barrier method of contraception up to 3 months after the end of study treatment.
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00997399
Start Date
March 1 2010
End Date
June 1 2014
Last Update
December 19 2020
Active Locations (5)
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1
University of Utah / Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84103
2
Novartis Investigative Site
Leiden, Netherlands, 2300 RC
3
Novartis Investigative Site
Utrecht, Netherlands, 3584CX
4
Novartis Investigative Site
Sankt Gallen, Switzerland, 9007