Clinical trial · Interventional
Japanese Study of the Combined Administration of Docetaxel With Prednisolone for Metastatic Hormone Refractory Prostate Cancer
An Extension 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.
NCT00723086CI-TRIAL-00002680completedPhase 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 the safety of docetaxel administered every 3 weeks repeatedly for 11 and more cycles and in combination with daily prednisolone for metastatic hormone refractory prostate cancer.
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 |
|---|---|---|---|
| Therapy, Prostatic Neoplasms | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel (XRP6976) | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Incidence rate of adverse events on each grade evaluated by National Cancer Institute Common Toxicity Criteria (Version 2.0)
- timeFrame
- First treatment up to 37 months
Secondary outcomes (1)
- measure
- No obvious disease progression
- timeFrame
- First treatment up to 37 months
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: Patients who completed the 10 cycles of docetaxel administrations in the preceding XRP6976J/2101 study and wish to continue docetaxel administrations,and who have no alternative therapy for hormone refractory prostate cancer according to the Investigator's judgment. Exclusion Criteria: * Continuation in the study would be detrimental to the patient's well-being * Development of life-threatening and/or toxic conditions not manageable by symptomatic care, dose reduction, or delay of dosing * Obvious disease progression (rising prostate specific antigen, any increase of ≥ 20 % in the sum of the measurable lesion in comparison to the nadir value, and progression in non-measurable lesion) * Patients treated with anti-cancer treatment other than study therapy after completion of 10 cycles of study treatment in the XRP6976J/2101 study
References
Publications (0)
Data not yet available
No reference posted for this study.