Clinical trial · Interventional
Investigation of Mass Balance of the Test Drug and Major Metabolites
Investigation of Mass Balance and Major Metabolites After Administration of 28 mg Radiolabeled ZK 219477 in Patients With Solid Tumor in an Open-label, Non Randomized Design
NCT00432302CI-TRIAL-00020182completedPhase 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: a) Determine how the body takes up the test drug and distributes it into various body organs and tissues, how it processes the drug and how it ultimately removes it; and b) Examine how well the test drug works against cancer, and whether it is safe and tolerable to take
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 |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sagopilone (BAY 86-5302, ZK 219477) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sagopilone
- description
- Subjects received 28 mg ZK 219477, containing 14 kBq/7.8 µg \[14C\]-ZK 219477 in the first infusion (Treatment course 1) followed by subsequent infusions (Treatment courses 2 to n \[till disease progression\]) of 16 mg/m2 ZK 219477 without radioactive label. Interval between the treatments was at least 21 days.
- interventionNames
- Drug: Sagopilone (BAY 86-5302, ZK 219477)
Primary outcomes (12)
- measure
- Blood, urine and fecal samples will be collected over a period of 336 hours (14 days) to measure 14C, ZK 219477 and its major metabolites following the intravenous administration of 14C-ZK 219477.
- timeFrame
- 14 days
- measure
- Cmax
- timeFrame
- 14 days
- description
- Maximum plasma concentration for \[14C\]-ZK 219477, ZK 219477
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male ≥ 18 years; female ≥ 50 years without childbearing potential (confirmed by either: age ≥ 60; or history of hysterectomy; or hormone analysis in serum: Estradiol ≤ 20 pg/mL and follicle stimulating hormone ≥ 40 IU/L) * Solid tumor * Adequate function of major organs * Failed previous cancer treatment * Peripheral venous access Exclusion Criteria: * Concurrent severe and/or uncontrolled disease * Brain tumors * Marked constipation
References
Publications (0)
Data not yet available
No reference posted for this study.