Clinical trial · Interventional
Evaluate the Effects of Patupilone on the Pharmacokinetics of Midazolam and Omeprazole in Patients With Advanced Malignancies
An Open Label Phase I Study to Evaluate the Effects of Patupilone on the Pharmacokinetics of Midazolam and Omeprazole in Patients With Advanced Malignancies
NCT00420615CI-TRIAL-00048679completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patupilone and Omeprazole | Drug | — | UNRESOLVED |
| Patupilone + Midalzolam | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Patupilone and Omeprazole
- description
- patupiloe + omeprazole
- interventionNames
- Drug: Patupilone and Omeprazole
- type
- EXPERIMENTAL
- label
- patupilone + midalzolam
- description
- patupilone + midalzolam
- interventionNames
- Drug: Patupilone + Midalzolam
Primary outcomes (2)
- measure
- To evaluate the effects of patupilone on the pharmacokinetics of midazolam in patients with advanced malignancies.
- timeFrame
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.