Status:
COMPLETED
Evaluate the Effects of Patupilone on the Pharmacokinetics of Midazolam and Omeprazole in Patients With Advanced Malignancies
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00420615
Start Date
December 1 2006
Last Update
December 8 2020
Active Locations (1)
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1
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030