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

Completed · Phase 1

Conditions studied: Advanced Malignancies

In brief

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

Key facts

Study ID

NCT00448396

Run by

Novartis Pharmaceuticals

People needed

17

Starts

2007-03-01

Last updated by the study team

2009-11-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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