Clinical trial · Interventional
ZK-Epo Given With Prednisone in Patients With Metastatic Androgen-independent Prostate Cancer
Phase 2 Study of ZK-Epothilone (ZK-Epo; ZK219477) Plus Prednisone as First-line Chemotherapy in Patients With Metastatic Androgen-independent Prostate Cancer
NCT00350051CI-TRIAL-00051150completedPhase 2ClinicalTrials.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 evaluate whether treatment with a new drug called ZK-Epothilone (ZK-Epo) given with prednisone in patients with androgen-independent prostate cancer, who have not had previous chemotherapy, is safe and helps to decrease PSA (Prostate-specific antigen) levels.
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 |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sagopilone (ZK 219477) + prednisone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- interventionNames
- Drug: Sagopilone (ZK 219477) + prednisone
Primary outcomes (1)
- measure
- PSA Response to treatment with ZK-Epo plus prednisone after 6 cycles
- timeFrame
- at least 28 days post day 21 of last cycle of treatment
Secondary outcomes (1)
- measure
- Safety & Tolerability of ZK-Epo plus prednisone
- timeFrame
- until progression, unknown duration
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must have evidence of confirmed metastatic prostate cancer * Serum testosterone must be less than 50 ng/mL * Disease must be progressing despite anti-androgen therapy * PSA level must be elevated * Additional criteria determined at screening visit Exclusion Criteria: * Any previous cytotoxic chemotherapy for prostate cancer * Use of any investigational drug in the last 4 weeks * Symptomatic brain tumors requiring radiation to the brain * Active infection * Additional criteria determined at screening visit
References
Publications (1)
- RESULTBeer TM, Smith DC, Hussain A, Alonso M, Wang J, Giurescu M, Roth K, Wang Y. Phase II study of first-line sagopilone plus prednisone in patients with castration-resistant prostate cancer: a phase II study of the Department of Defense Prostate Cancer Clinical Trials Consortium. Br J Cancer. 2012 Aug 21;107(5):808-13. doi: 10.1038/bjc.2012.339. Epub 2012 Jul 31. PMID 22850553