NCT00420524

A Study of Patupilone in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Function

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Advanced Malignancies
• Tumors

Interventions

Type	Name	Description
DRUG	Patupilone/EPO906

Timeline

• Start date: 2006-01-01
• Primary completion: 2010-07-01
• First posted: 2007-01-11
• Last updated: 2020-12-09

Locations

4 sites across 1 country: United States