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: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and tolerability in patients with hepatic impairment will be assessed by adverse events (AEs), serious adverse events (SAEs) and out of range lab values
at completion of the study
Yes
Novartis Pharmaceuticals
Study Director
Novartis Pharmeceuticals
United States: Food and Drug Administration
CEPO906A2121E1
NCT00421044
May 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 |
Institute for Drug Development Cancer Therapy & Research Center/The University of Texas Health Science Center | San Antonio, Texas 78229 |