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

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ClinicalTrials.gov Identifier: NCT00468260
Recruitment Status : Terminated (pts. will be captured in core)
First Posted : May 2, 2007
Last Update Posted : November 19, 2009
Sponsor:
Information provided by:
Novartis

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 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-extension Study
Study Start Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
Drug Information available for: Warfarin
U.S. FDA Resources




Primary Outcome Measures :
  1. Safety
  2. Tolerability
  3. Potential activity of patupilone once every 21 days in patients that completed the core study

Secondary Outcome Measures :
  1. Objective response and tumor evaluation assessed by response evaluation criteria in solid tumors (RECIST)


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

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): NCT00468260


Locations
United States, Texas
San Antonio, Texas, United States
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00468260     History of Changes
Other Study ID Numbers: CEPO906A2120E1
First Posted: May 2, 2007    Key Record Dates
Last Update Posted: November 19, 2009
Last Verified: November 2009

Keywords provided by Novartis:
Cancer
EPO906
Patupilone

Additional relevant MeSH terms:
Neoplasms
Warfarin
Epothilone B
Epothilones
Anticoagulants
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action