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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00448396

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Advanced Malignancies	Drug: Patupilone	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 :

Mar 1, 2007

Actual Primary Completion Date :

Feb 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patupilone	Drug: Patupilone

Arm

Intervention/Treatment

Experimental: Patupilone

Drug: Patupilone

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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 Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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