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

This study has been terminated.

( pts. will be captured in core )

First Received: May 1, 2007 Last Updated: May 24, 2007 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00468260

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

MedlinePlus related topics: Blood Thinners Cancer

Drug Information available for: Warfarin Epothilone B

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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-Extension Study

Further study details as provided by Novartis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	12
Study Start Date:	May 2007

Eligibility

Criteria

Inclusion criteria Participation in study EPO906A2120E1

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
Completed all PK sampling in the core study

Exclusion criteria

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00468260

Locations

United States, Texas

San Antonio, Texas, United States

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

No publications provided

Study ID Numbers:	CEPO906A2120E1
Study First Received:	May 1, 2007
Last Updated:	May 24, 2007
ClinicalTrials.gov Identifier:	NCT00468260 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Cancer
EPO906
Patupilone

Study placed in the following topic categories:

Epothilone B
Epothilones
Tubulin Modulators
Antimitotic Agents
Warfarin

Additional relevant MeSH terms:

Epothilone B
Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009