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
| NCT number | NCT00420615 |
| Other study ID # | CEPO906A2123 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 1 |
| First received | |
| Last updated | |
| Start date | December 2006 |
| Verified date | April 2012 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | The University of Texas MD Anderson Cancer Center | Houston | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States,
| 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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