Evaluate the Effects of Patupilone on the Pharmacokinetics and Pharmacodynamics of Warfarin in Patients With Advanced Malignancies

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the effects of patupilone on the pharmacokinetics of warfarin in patients with advanced malignancies.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Epothilone B; Epothilones; Warfarin

Criteria

Inclusion criteria

• Age ≥ 18 years of age

• Life expectancy ≥3 months

• Histologically documented advanced solid tumors which have progressed after standard systemic therapy or for which standard systemic therapy does not exist

• Agents containing warfarin or heparin must be discontinued 7 days prior to enrollment in the study

Exclusion criteria

• History of/or active bleeding disorders

• Known hypersensitivity to warfarin or related compounds

• The use of vitamin K

• Central lines that require anticoagulant maintenance

• The use of agents containing warfarin and heparin

• Known diagnosis of human immunodeficiency virus (HIV) infection, hepatitis Other protocol-defined inclusion/exclusion criteria may apply