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

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ClinicalTrials.gov Identifier: NCT00448396
Recruitment Status : Completed
First Posted : March 16, 2007
Last Update Posted : November 19, 2009
Sponsor:
Information provided by:
Novartis

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : March 2007
Actual Primary Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arms and Interventions
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Arm Intervention/treatment
Experimental: Patupilone Drug: Patupilone


Outcome Measures
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Primary Outcome Measures :
  1. To evaluate the effects of patupilone on the pharmacokinetics of warfarin in patients with advanced malignancies.

Secondary Outcome Measures :
  1. To evaluate the effects of patupilone on the pharmacodynamics of warfarin in patients with advanced malignancies.
  2. 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00448396


Locations
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United States, Texas
San Antonio, Texas, United States
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00448396    
Other Study ID Numbers: CEPO906A2120
First Posted: March 16, 2007    Key Record Dates
Last Update Posted: November 19, 2009
Last Verified: November 2009
Keywords provided by Novartis:
Cancer
EPO
Patupilone
Solid tumors
Advanced malignancies
Additional relevant MeSH terms:
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Neoplasms
Epothilone B
Antineoplastic Agents
Tubulin Modulators
 Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action