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

Novartis

Status and phase: Completed; Phase 1

Conditions: Advanced Malignancies

Treatments: Drug: Patupilone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00448396

CEPO906A2120

Details and patient eligibility

About

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

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• 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
• Agents containing warfarin or heparin must be discontinued 7 days prior to enrollment in the study

Exclusion criteria

• History of/or active bleeding disorders
• Known hypersensitivity to warfarin or related compounds
• The use of vitamin K
• Central lines that require anticoagulant maintenance
• The use of agents containing warfarin and heparin
• Known diagnosis of human immunodeficiency virus (HIV) infection, hepatitis 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)

---

17 participants in 1 patient group

Patupilone

Experimental group

Treatment:

Drug: Patupilone