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An Open Label Phase I Study to Evaluate the Effects of Patupilone on the Pharmacokinetics and Pharmacodynamics of Warfarin in Patients With Advanced Malignancies


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Malignancies

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Trial Information

An Open Label Phase I Study to Evaluate the Effects of Patupilone on the Pharmacokinetics and Pharmacodynamics of Warfarin in Patients With Advanced Malignancies

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Chair

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CEPO906A2120

NCT ID:

NCT00448396

Start Date:

March 2007

Completion Date:

Related Keywords:

  • Advanced Malignancies
  • Cancer
  • EPO
  • Patupilone
  • Solid tumors
  • Advanced malignancies
  • Neoplasms

Name

Location

Austin, Texas  78705