Study to Evaluate Panobinostat (DACi) Pharmacokinetics and Safety in Solid Tumors and Varying Renal Function
NCT ID: NCT00997399
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
37 participants
INTERVENTIONAL
2010-03-31
2014-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
To date, the pharmacokinetics (PK) of panobinostat has been characterized in patients with solid tumors and hematological malignancies participating in several phase I/II clinical studies. Panobinostat PK does not appear to be different in patients with solid tumors and hematological malignancies. However, the effect of organ dysfunction on PK of panobinostat is yet to be elucidated.
Kidney and liver are involved in the elimination and metabolism of panobinostat. The current study is designed to evaluate the impact of renal function status on panobinostat PK.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
LBH589
panobinostat (LBH589)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
panobinostat (LBH589)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patient has normal or abnormal renal organ function
3. Patient has provided written informed consent prior to any screening procedures
Exclusion Criteria
2. Patient received prior treatment with DAC inhibitors including panobinostat
3. Patient requiring dialysis
4. Patient requiring diuretics unless patient is taking potassium sparring diuretics
5. Patient has acute renal failure, history of transplant, ESRD (however acceptable severe renal impaired group)
6. 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Utah / Huntsman Cancer Institute
Salt Lake City, Utah, United States
Novartis Investigative Site
Leiden, , Netherlands
Novartis Investigative Site
Utrecht, , Netherlands
Novartis Investigative Site
Sankt Gallen, , Switzerland
Novartis Investigative Site
Merseyside, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Sharma S, Witteveen PO, Lolkema MP, Hess D, Gelderblom H, Hussain SA, Porro MG, Waldron E, Valera SZ, Mu S. A phase I, open-label, multicenter study to evaluate the pharmacokinetics and safety of oral panobinostat in patients with advanced solid tumors and varying degrees of renal function. Cancer Chemother Pharmacol. 2015 Jan;75(1):87-95. doi: 10.1007/s00280-014-2612-8. Epub 2014 Nov 7.
Related Links
Access external resources that provide additional context or updates about the study.
Results for CLBH589X2105 on the Novartis Clinical Trial Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2009-012263-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLBH589X2105
Identifier Type: -
Identifier Source: org_study_id