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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Epothilone B; Epothilones; Midazolam; Omeprazole

Criteria

Inclusion criteria:

• 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

Exclusion criteria:

• 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.