Evaluate the Effects of Patupilone on the Pharmacokinetics and Pharmacodynamics of Warfarin in Patients With Advanced Malignancies
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Advanced Malignancies
Intervention: Patupilone (Drug)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis, Study Chair, Affiliation: Novartis
Summary
To evaluate the effects of patupilone on the pharmacokinetics of warfarin in patients with
advanced malignancies.
Clinical Details
Official title: An Open Label Phase I Study to Evaluate the Effects of Patupilone on the Pharmacokinetics and Pharmacodynamics of Warfarin in Patients With Advanced Malignancies
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: To evaluate the effects of patupilone on the pharmacokinetics of warfarin in patients with advanced malignancies.
Secondary outcome: To evaluate the effects of patupilone on the pharmacodynamics of warfarin in patients with advanced malignancies.Safety and tolerability of patupilone when administered concomitantly with warfarin in patients with advanced malignancies will be assessed by AE's, SAE's and safety labs.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
San Antonio, Texas, United States
Additional Information
Starting date: December 2006
Last updated: May 1, 2008
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