An Open Label Phase I Study to Evaluate the Effects of Patupilone on the Pharmacokinetics of Midazolam and Omeprazole in Patients With Advanced Malignancies
- 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
- 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.
Type of Study:
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the effects of patupilone on the pharmacokinetics of midazolam in patients with advanced malignancies.
Outcome Time Frame:
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)
United States: Food and Drug Administration
- Solid Tumors
|The University of Texas MD Anderson Cancer Center
||Houston, Texas 77030-4009