Clinical trial · Interventional
Evaluate the Effects of Patupilone on the Pharmacokinetics and Pharmacodynamics of Warfarin in Patients With Advanced Malignancies
An Open Label Phase I Study to Evaluate the Effects of Patupilone on the Pharmacokinetics and Pharmacodynamics of Warfarin in Patients With Advanced Malignancies
NCT00448396CI-TRIAL-00002791completedPhase 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)
To evaluate the effects of patupilone on the pharmacokinetics of warfarin in patients with advanced malignancies.
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 |
|---|---|---|---|
| Advanced Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patupilone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patupilone
- interventionNames
- Drug: Patupilone
Primary outcomes (1)
- measure
- To evaluate the effects of patupilone on the pharmacokinetics of warfarin in patients with advanced malignancies.
Secondary outcomes (2)
- measure
- To evaluate the effects of patupilone on the pharmacodynamics of warfarin in patients with advanced malignancies.
- measure
- Safety and tolerability of patupilone when administered concomitantly with warfarin in patients with advanced malignancies will be assessed by AE's, SAE's and safety labs.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria * Age ≥ 18 years of age * Life expectancy ≥3 months * Histologically documented advanced solid tumors which have progressed after standard systemic therapy or for which standard systemic therapy does not exist * Agents containing warfarin or heparin must be discontinued 7 days prior to enrollment in the study Exclusion criteria * History of/or active bleeding disorders * Known hypersensitivity to warfarin or related compounds * The use of vitamin K * Central lines that require anticoagulant maintenance * The use of agents containing warfarin and heparin * Known diagnosis of human immunodeficiency virus (HIV) infection, hepatitis Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available
No reference posted for this study.