Clinical trial · Interventional
A Study of Patupilone in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Function
An Open-label, Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Patupilone in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Function
- 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)
This phase I study will determine the pharmacokinetic profile of patupilone in patients with mild or moderately impaired hepatic function within 2 cycles of treatment. The study population for this trial consists of patients with a documented advanced solid tumor. Patients will be stratified into 3 groups: those with normal liver function, and those with mild or moderate liver dysfunction.
Conditions
Conditions (2)
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 | — |
| Tumors | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patupilone/EPO906 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm A (Normal liver function)
- interventionNames
- Drug: Patupilone/EPO906
- type
- EXPERIMENTAL
- label
- Arm B (Mild liver dysfunction)
- interventionNames
- Drug: Patupilone/EPO906
- type
- EXPERIMENTAL
- label
- Arm C (Moderate liver dysfunction)
- interventionNames
- Drug: Patupilone/EPO906
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years of age or older * World Health Organization (WHO) Performance Status score of: 0 - you are fully active and more or less as you were before your illness; 1 - you cannot carry out heavy physical work, but can do anything else; or 2 - you are up and about more than half the day, you can look after yourself, but are not well enough to work. * Life expectancy of 3 months or more * Patients with measurable or evaluable disease who have histologically documented advanced solid tumor and who have progressed after systemic therapy or for whom standard systemic therapy does not exist Exclusion Criteria: * Severe and/or uncontrolled medical disease * Known diagnosis of human immunodeficiency virus (HIV) infection * Presence of any other active or suspected acute or chronic uncontrolled infection * Severe cardiac insufficiency, with uncontrolled and/or unstable cardiac or coronary artery disease * History of another malignancy within 5 years prior to study entry, except for curatively treated non-melanotic skin cancer or cervical cancer in situ Other protocol-defined inclusion/exclusion criteria may apply.
References
Publications (0)
Data not yet available