Text Size

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

This study has been terminated.
(pts. will be captured in core)
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00468260
First received: May 1, 2007
Last updated: November 18, 2009
Last verified: November 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Advanced Malignancies
 Drug: Patupilone
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

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

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

Estimated Enrollment: 12
Study Start Date: May 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00468260

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

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00468260     History of Changes
Other Study ID Numbers: CEPO906A2120E1
Study First Received: May 1, 2007
Last Updated: November 18, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Cancer
EPO906
Patupilone

Additional relevant MeSH terms:
Neoplasms
Warfarin
Epothilone B
Anticoagulants
Hematologic Agents
Therapeutic Uses
 Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 16, 2013