Trial Information
An Open Label Phase I Study to Evaluate the Effects of Patupilone on the Pharmacokinetics and Pharmacodynamics of Warfarin in Patients With Advanced Malignancies
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To evaluate the effects of patupilone on the pharmacokinetics of warfarin in patients with advanced malignancies.
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Chair
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CEPO906A2120
NCT ID:
NCT00448396
Start Date:
March 2007
Completion Date:
Related Keywords:
- Advanced Malignancies
- Cancer
- EPO
- Patupilone
- Solid tumors
- Advanced malignancies
- Neoplasms
Name | Location |
|
Austin, Texas 78705 |