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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Epothilone B
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 20, 2014