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

• Status: Terminated
• 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 Participation in study EPO906A2120E1

• 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

• Completed all PK sampling in the core study

Exclusion criteria

• Known diagnosis of human immunodeficiency virus (HIV) infection, hepatitis

• Female patients who are pregnant or breast feeding

• Patients with a severe and/or uncontrolled medical disease

Other protocol-defined inclusion/exclusion criteria may apply