Evaluate the Effects of Patupilone on the Pharmacokinetics and Pharmacodynamics of Warfarin in Patients With Advanced Malignancies
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|ClinicalTrials.gov Identifier: NCT00448396|
Recruitment Status : Completed
First Posted : March 16, 2007
Last Update Posted : November 19, 2009
|Condition or disease||Intervention/treatment||Phase|
|Advanced Malignancies||Drug: Patupilone||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||March 2007|
|Actual Primary Completion Date :||February 2008|
- To evaluate the effects of patupilone on the pharmacokinetics of warfarin in patients with advanced malignancies.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00448396
|United States, Texas|
|San Antonio, Texas, United States|
|Study Chair:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|