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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

May 1, 2007

Last Updated Date

May 24, 2007

Start Date ^†

May 2007

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00468260 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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

Brief Summary

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

Detailed Description

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Advanced Malignancies

Intervention ^†

Drug: Patupilone

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Terminated

Estimated Enrollment ^†

Completion Date

Primary Completion Date

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

Known diagnosis of human immunodeficiency virus (HIV) infection, hepatitis
Female patients who are pregnant or breast feeding
Patients with a severe and/or uncontrolled medical disease

Other protocol-defined inclusion/exclusion criteria may apply

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00468260

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Novartis

Collaborators ^††

Investigators ^†

Study Chair:

Novartis

Information Provided By

Novartis

Verification Date

May 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.