Status:
COMPLETED
Evaluate the Effects of Patupilone on the Pharmacokinetics and Pharmacodynamics of Warfarin in Patients With Advanced Malignancies
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Advanced Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To evaluate the effects of patupilone on the pharmacokinetics of warfarin in patients with advanced malignancies.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00448396
Start Date
March 1 2007
Last Update
November 19 2009
Active Locations (1)
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1
San Antonio, Texas, United States