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
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Advanced Malignancies
Both
Advanced Malignancies
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-extension Study
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Chair
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CEPO906A2120E1
NCT ID:
NCT00468260
Start Date:
May 2007
Completion Date:
Related Keywords:
- Advanced Malignancies
- Cancer
- EPO906
- Patupilone
- Neoplasms
Name | Location |
|---|---|
| Austin, Texas 78705 |
