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

Advanced Malignancies Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00468260
• Other study ID #: CEPO906A2120E1
• Status: Terminated
• Phase: Phase 1
• First received: May 1, 2007
• Last updated: November 18, 2009
• Start date: May 2007

Study information

• Verified date: November 2009
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Malignancies
• Neoplasms

Intervention

Drug:
• Patupilone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety
Primary	Tolerability
Primary	Potential activity of patupilone once every 21 days in patients that completed the core study
Secondary	Objective response and tumor evaluation assessed by response evaluation criteria in solid tumors (RECIST)