Pharmacokinetics and Safety of Panobinostat in Patients With Advanced Solid Tumors and Various Degrees of Hepatic Function
NCT ID: NCT01007968
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
25 participants
INTERVENTIONAL
2010-03-31
2012-11-30
Brief Summary
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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 hepatic function status on panobinostat PK.
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
OTHER
NONE
Study Groups
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HDACi
LBH589
Interventions
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LBH589
Eligibility Criteria
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Inclusion Criteria
2. Patient has normal or abnormal hepatic 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 requires treatment with warfarin that cannot be switched to another anticoagulant treatment prior to starting study drug
4. Patient has encephalopathy
5. Patient has ascites requiring intervention
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
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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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University of Utah / Huntsman Cancer Institute
Salt Lake City, Utah, United States
Novartis Investigative Site
Leiden, , Netherlands
Novartis Investigative Site
Lund, , Sweden
Novartis Investigative Site
Stockholm, , Sweden
Novartis Investigative Site
Sankt Gallen, , Switzerland
Novartis Investigative Site
Edinburgh, , United Kingdom
Countries
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References
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Slingerland M, Hess D, Clive S, Sharma S, Sandstrom P, Loman N, Porro MG, Mu S, Waldron E, Valera SZ, Gelderblom H. A phase I, open-label, multicenter study to evaluate the pharmacokinetics and safety of oral panobinostat in patients with advanced solid tumors and various degrees of hepatic function. Cancer Chemother Pharmacol. 2014 Nov;74(5):1089-98. doi: 10.1007/s00280-014-2594-6. Epub 2014 Sep 25.
Related Links
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Results for CLBH589X2101 on the Novartis clinical trial website
Other Identifiers
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2009-012262-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLBH589X2101
Identifier Type: -
Identifier Source: org_study_id