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

Phase 1

Completed

• Conditions: Advanced Malignancies
• Interventions: Drug: Patupilone

• Registration Number: NCT00448396
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-03-15
• Study First Submitted QC: 2007-03-15
• Study First Posted: 2007-03-16
• Primary Completion: 2008-02
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-18
• Last Update Posted: 2009-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patupilone	Patupilone	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.