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

Novartis

Status and phase: Terminated; Phase 1

Conditions: Advanced Malignancies

Treatments: Drug: Patupilone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00468260

CEPO906A2120E1

Details and patient eligibility

About

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

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)