Clinical trial · Interventional
Efficacy and Safety of Patupilone in Men (≥18 Years) With Metastatic Hormone Refractory Prostate Cancer
A Randomized Multicenter Phase II Trial of Patupilone (EPO906) Plus Prednisone Versus Docetaxel Plus Prednisone in Patients With Metastatic Hormone Refractory Prostate Cancer
NCT00411528CI-TRIAL-00048933completedPhase 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 objective of this study is to assess the response of patupilone plus prednisone compared to docetaxel plus prednisone on prostate specific antigen (PSA) in patients with metastatic hormone refractory prostate cancer. Additionally, this study will assess the response on measureable disease and the effects on patient-reported outcomes.
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 |
|---|---|---|---|
| Metastatic Hormone Refractory Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| Patupilone | Drug | — | UNRESOLVED |
| prednisone | Drug | Prednisone | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- 1: 8 mg/m2 study drug + prednisone
- description
- Patupilone 8 mg/m2 + prednisone 5 mg bid daily
- interventionNames
- Drug: Patupilone
- Drug: prednisone
- type
- EXPERIMENTAL
- label
- 2: study drug + prednisone days 1 -8
- description
- Patupilone 10 mg/m2 + prednisone days 1 -8 at 25 mg bid, day 9 at 20 mg bid, day 10 at 15 mg bid, day 11 at 10 mg bid, day 12 - 21 at 5 mg bid
- interventionNames
- Drug: Patupilone
- Drug: prednisone
- type
- EXPERIMENTAL
- label
- 3: Study drug + prednisone days 1 - 4
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Must be ≥ 18 years of age * Confirmed and documented diagnosis of prostate cancer * Confirmed and documented evidence of progression of disease (hormone refractory) * Low testosterone levels * Chemotherapy-naïve Exclusion criteria: * Recent radiation therapy (within 4 weeks) * Known brain metastasis * Peripheral neuropathy * Active diarrhea * Significant illnesses such as heart disease, diabetes, or chronic or uncontrolled infections * Allergic reactions to patupilone or docetaxel or prednisone or similar compounds Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (1)
- DERIVEDde Liano AG, Reig O, Mellado B, Martin C, Rull EU, Maroto JP. Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer. Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10. PMID 24722180