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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Terminated
CT.gov ID
NCT00468260
Collaborator
(none)
12
Enrollment
1
Location

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated 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 1, 2007

Outcome Measures

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) []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Locations

Site City State Country Postal Code
1 San Antonio Texas United States

Sponsors and Collaborators

  • Novartis Pharmaceuticals

Investigators

  • Study Chair: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00468260
Other Study ID Numbers:
  • CEPO906A2120E1
First Posted:
May 2, 2007
Last Update Posted:
Nov 19, 2009
Last Verified:
Nov 1, 2009
Keywords provided by , ,
Cancer
EPO906
Patupilone
Additional relevant MeSH terms:
Neoplasms
Epothilone B

Study Results

No Results Posted as of Nov 19, 2009