Evaluate the Effects of Patupilone on the Pharmacokinetics of Midazolam and Omeprazole in Patients With Advanced Malignancies
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Solid Tumors
Intervention: Patupilone and Omeprazole (Drug); Patupilone + Midalzolam (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Novartis Pharmaceuticals Official(s) and/or principal investigator(s): Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmeceuticals
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.
Clinical Details
Official title: An Open Label Phase I Study to Evaluate the Effects of Patupilone on the Pharmacokinetics of Midazolam and Omeprazole in Patients With Advanced Malignancies
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To evaluate the effects of patupilone on the pharmacokinetics of midazolam in patients with advanced malignancies.To evaluate the effects of patupilone on the pharmacokinetics of omeprazole in patients with advanced malignancies
Secondary outcome: To evaluate the safety and tolerability of Patupilone when administered concomitantly with midazolam in patients with advanced malignancies.To evaluate the safety and tolerability of Patupilone when administered concomitantly with omeprazole in patients with advanced malignancies.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
The University of Texas MD Anderson Cancer Center, Houston, Texas 77030, United States
Additional Information
Starting date: December 2006
Last updated: April 23, 2012
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