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

Phase 1

Terminated

• Conditions: Advanced Malignancies

• Registration Number: NCT00468260
• 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: 2007-05
• Study First Submitted: 2007-05-01
• Study First Submitted QC: 2007-05-01
• Study First Posted: 2007-05-02
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-18
• Last Update Posted: 2009-11-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety
Tolerability
Potential activity of patupilone once every 21 days in patients that completed the core study

Secondary Outcome Measures

Name	Time	Method
Objective response and tumor evaluation assessed by response evaluation criteria in solid tumors (RECIST)