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

Phase 1TerminatedNCT00468260

Novartis Pharmaceuticals12 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Malignancies

Interventions

PatupiloneDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Safety

Tolerability

Potential activity of patupilone once every 21 days in patients that completed the core study

Secondary Outcomes

Objective response and tumor evaluation assessed by response evaluation criteria in solid tumors (RECIST)

Data from ClinicalTrials.gov

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