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

Study Overview
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Brief Summary
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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.

Official Title
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An Open Label Phase I Study to Evaluate the Effects of Patupilone on the Pharmacokinetics of Midazolam and Omeprazole in Patients With Advanced Malignancies

Conditions
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Solid Tumors

Intervention / Treatment
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* Drug: Patupilone and Omeprazole
* Drug: Patupilone + Midalzolam


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patupilone and Omeprazole<br>patupiloe + omeprazole | Drug: Patupilone and Omeprazole<br> <br> |
| Experimental: patupilone + midalzolam<br>patupilone + midalzolam | Drug: Patupilone + Midalzolam<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, EPO906, Patupilone