Clinical trial · Interventional
Evaluate the Effects of Patupilone on the Pharmacokinetics of Midazolam and Omeprazole in Patients With Advanced Malignancies (Extension)
An Open Label Phase I Study to Evaluate the Effects of Patupilone on the Pharmacokinetics of Midazolam and Omeprazole in Patients With Advanced Malignancies (Extension)
NCT00442741CI-TRIAL-00006786withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): pts. will be captured in core
Summary
Brief summary (as posted)
The purpose of this extension 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 | Drug | — | UNRESOLVED |
| Patupilone + Omeprazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Patupilone + Midazolam
- interventionNames
- Drug: Patupilone
- type
- EXPERIMENTAL
- label
- Patupilone + Omeprazole
- interventionNames
- Drug: Patupilone + Omeprazole
Primary outcomes (1)
- measure
- To evaluate the safety, tolerability and potential activity of patupilone once every 21 days in patients that completed the core study
Secondary outcomes (1)
- measure
- Assessment of objective response and tumor evaluation will be based on the response evaluation criteria in solid tumors (RECIST)
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 * Completed the Core study * Completed all sampling in the core and not dose reduced Patients with adequate hematologic parameters Exclusion criteria: * 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.