Evaluate the Effects of Patupilone on the Pharmacokinetics of Midazolam and Omeprazole in Patients With Advanced Malignancies

Completed · Phase 1

Conditions studied: Solid Tumors

In brief

The purpose of this study is to evaluate the potential inhibitory effects of patupilone on metabolism using midazolam and omeprazole as the respective probe drugs.

Key facts

Study ID

NCT00420615

Run by

Novartis Pharmaceuticals

People needed

34

Starts

2006-12-01

Last updated by the study team

2020-12-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients 18 years or older
• Histologically documented advanced solid tumor, who have failed standard systemic therapy, or for whom standard systemic therapy does not exist
• Life expectancy of 3 months or more
• Patients with adequate hematologic parameters

You may not qualify if…

• Hypersensitivity to midazolam or omeprazole or related compounds
• Female patients who are pregnant or breast-feeding.
• Patients with a severe and/or uncontrolled medical disease
• Patients with a known diagnosis of human immunodeficiency virus (HIV) infection
• Patients having received an investigational agent within 30 days prior to study entry
• Other protocol defined inclusion/exclusion criteria may apply.

Where it is running

• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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