Clinical trial · Interventional
PhII One Label Non-Comparative Trial in Metastatic Hormone Refractory Prostate Cancer in Combination With Prednisolone
A Multicenter Phase II Open Label Non-Comparative Trial of RP56976 Administered Every Three Weeks in Combination With Daily Prednisolone for Metastatic Hormone Refractory Prostate Cancer
NCT00291005CI-TRIAL-00002165completedPhase 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)
* To evaluate the overall tumor response rate in subjects with metastatic hormone refractory prostate cancer * To evaluate PSA (tumor marker) response rate * To evaluate safety
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 |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ARD6562, Docetaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall tumor response rate by Response Evaluation Criteria in Solid Tumor (RECIST)
Secondary outcomes (1)
- measure
- Overall response rate by modified WHO criteria, PSA response rate, safety
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 20 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * Men with prostate adenocarcinoma with at least one metastatic lesion which is measurable and who progressed after prior hormonal therapy. Exclusion Criteria: * 1.Body temperature \> 38 degree centigrade. * 2.Prior radiotherapy to \> 25% of bone marrow. * 3.Prior isotope therapy and/or brachytherapy * 4.Prior gene therapy. * 5.Active double cancer. * 6.Known brain or leptomeningeal involvement. * 7.History of hypersensitivity reaction to drug * 8.Other serious illness or medical condition * 9.Subjects whom the investigators consider inappropriate from social or medical aspects.
References
Publications (0)
Data not yet available
No reference posted for this study.