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NCT00420615 Clinical Trial

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

Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00420615
Other study ID # CEPO906A2123
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date December 2006

Study information
Verified date April 2012
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 34
Est. completion date
Est. primary completion date August 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Patupilone and Omeprazole

• Patupilone + Midalzolam

Locations
Country Name City State
United States The University of Texas MD Anderson Cancer Center Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate the effects of patupilone on the pharmacokinetics of midazolam in patients with advanced malignancies. Day 1 (0.5h, 1h, 1.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h), Day 29 (0.5h, 1h, 1.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h)
Primary To evaluate the effects of patupilone on the pharmacokinetics of omeprazole in patients with advanced malignancies Day 1 (0.33h (20m), 0.67h (40m), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h)
Secondary To evaluate the safety and tolerability of Patupilone when administered concomitantly with midazolam in patients with advanced malignancies. at each visit (week 1, week 2, week 5, and end of study)
Secondary To evaluate the safety and tolerability of Patupilone when administered concomitantly with omeprazole in patients with advanced malignancies. at each visit (week 1, week 2, week 5, and end of study)
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