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OpenTrials
Completed

NCT Number: NCT00448396

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

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

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Key information

Conditions

Advanced Malignancies Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

San Antonio, Texas, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patupilone

Drug

Primary outcomes

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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
First posted
Mar 16, 2007
Registry last updated
Nov 19, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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