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

This study has been completed.

First Received on March 15, 2007. Last Updated on November 18, 2009 History of Changes

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00448396

Purpose

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

Condition	Intervention	Phase
Advanced Malignancies	Drug: Patupilone	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners Cancer

Drug Information available for: Warfarin Epothilone B Warfarin sodium Warfarin potassium

U.S. FDA Resources

Further study details as provided by Novartis:

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.

Enrollment:	17
Study Start Date:	March 2007
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Patupilone	Drug: Patupilone

Eligibility

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00448396

Locations

United States, Texas

San Antonio, Texas, United States

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Chair:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00448396 History of Changes
Other Study ID Numbers:	CEPO906A2120
Study First Received:	March 15, 2007
Last Updated:	November 18, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Cancer
EPO
Patupilone
Solid tumors
Advanced malignancies

Additional relevant MeSH terms:

Neoplasms
Warfarin
Epothilone B
Anticoagulants
Hematologic Agents
Therapeutic Uses

Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 09, 2012