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An Open-label, Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Patupilone in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Function
This phase I study will determine the pharmacokinetic profile of patupilone in patients with mild or moderately impaired hepatic function within 2 cycles of treatment. The study population for this trial consists of patients with a documented advanced solid tumor. Patients will be stratified into 3 groups: those with normal liver function, and those with mild or moderate liver dysfunction.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of California San Diego/Moores Cancer Center
La Jolla, California, United States
Cancer Research and Treatment Center
Albuquerque, New Mexico, United States
Institute for Drug Development Cancer Therapy & Research Center/The University of Texas Health Science
San Antonio, Texas, United States
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States
Start Date
January 1, 2006
Primary Completion Date
July 1, 2010
Last Updated
December 9, 2020
36
ACTUAL participants
Patupilone/EPO906
DRUG
Lead Sponsor
Novartis Pharmaceuticals
NCT06898450
NCT01247597
Data Source & Attribution
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