Clinical trial · Interventional
Pharmacokinetics of Patupilone After a Single Intravenous Administration in Patients With Advance Solid Tumor Malignancies.
An Open-label Single Center Study to Characterize the Absorption, Distribution, Metabolism, and Elimination (ADME) of Patupilone (EPO906) After a Single Intravenous Administration of 10 mg/m2 [14C] Patupilone in Patients With Advanced Solid Tumor Malignancies.
NCT00426140CI-TRIAL-00048681completedPhase 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 main purpose of this study is to characterize the distribution, metabolism, and elimination (ADME) of Patupilone after a single intravenous administration in patients with advanced solid tumor malignancies
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 | — |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patupilone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EPO906
- interventionNames
- Drug: Patupilone
Primary outcomes (1)
- measure
- To characterize the pharmacokinetic profile of patupilone including any potential metabolite(s) in blood/plasma as well as the total radioactivity in blood and plasma.
- timeFrame
- one week
Secondary outcomes (2)
- measure
- Safety and tolerability will be assessed by AEs, SAEs and out of range lab values.
- timeFrame
- every 6 weeks
- measure
- Radiological scans will also be completed at approximately 6 weeks to asses anti-tumor activity.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 18 years or older 2. 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. 3. Adequate hematological laboratory parameters 4. No major impairment of renal or hepatic function 5. Female patients must have a negative serum pregnancy test at screening. Exclusion Criteria: 1. Severe and/or uncontrolled medical disease; 2. Severe cardiac insufficiency with uncontrolled and/or unstable cardiac or coronary artery disease; 3. Known diagnosis of human immunodeficiency virus (HIV) infection; 4. Presence of any other active or suspected acute or chronic uncontrolled infection; 5. Symptomatic brain metastases or leptomeningeal disease. Other protocol-defined inclusion/exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.