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
Interventional
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the effect of hepatic impairment on the pharmacokinetics of patupilone and its metabolite
After completion of the study (approximately 6 weeks from treatment)
Yes
Novartis Pharmaceuticals
Study Director
Novartis Pharmeceuticals
United States: Food and Drug Administration
CEPO906A2121
NCT00420524
January 2006
Name | Location |
---|---|
South Texas Accelerated Research Therapeutics | San Antonio, Texas 78229 |
University of California San Diego/Moores Cancer Center | La Jolla, California 92093-0987 |
Cancer Research and Treatment Center | Albuquerque, New Mexico 87131-5636 |
Institute for Drug Development Cancer Therapy & Research Center/The University of Texas Health Science | San Antonio, Texas 78229 |