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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

Page last updated: August 23, 2015

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