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

NCT ID: NCT00448396

Last Updated: 2009-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Brief Summary

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

Detailed Description

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Conditions

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Advanced Malignancies

Keywords

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Cancer EPO Patupilone Solid tumors Advanced malignancies

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patupilone

Group Type EXPERIMENTAL

Patupilone

Intervention Type DRUG

Interventions

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Patupilone

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis Pharmaceuticals

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_CHAIR

Novartis Pharmaceuticals

Locations

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San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CEPO906A2120

Identifier Type: -

Identifier Source: org_study_id