Evaluate the Effects of Patupilone on the Pharmacokinetics of Midazolam and Omeprazole in Patients With Advanced Malignancies
Phase 1
Completed
- Conditions
- Solid Tumors
- Interventions
- Registration Number
- NCT00420615
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description patupilone + midalzolam Patupilone + Midalzolam patupilone + midalzolam Patupilone and Omeprazole Patupilone and Omeprazole patupiloe + omeprazole
- Primary Outcome Measures
Name Time Method 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) 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)
- Secondary Outcome Measures
Name Time Method 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) 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)
Trial Locations
- Locations (1)
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States