Clinical trial · Interventional
Efficacy and Safety Study of Xyotax to Treat Prostate Cancer
Phase II Study of Xyotax in Advanced Hormone Refractory Prostate Cancer
NCT00446836CI-TRIAL-00021412completedPhase 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 determine whether Xyotax, a conjugate of the taxane drug paclitaxel, is effective in the treatment of prostate cancer that is no longer responsive to hormone therapy.
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 |
|---|---|---|---|
| Paclitaxel polyglumex (Xyotax) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Single arm
- description
- Open label use of Xyotax
- interventionNames
- Drug: Paclitaxel polyglumex (Xyotax)
Primary outcomes (2)
- measure
- PSA response
- timeFrame
- during trial (data from study not available)
- description
- data from study not available
- measure
- Correlation with soft tissue response
- timeFrame
- during trial (data from study not available)
- description
- data from study not available
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Progressing adenocarcinoma of the prostate having failed prior hormone therapy * Free of serious co-morbidity * Have a life expectancy of ≥ 24 weeks * Maintaining castrate status (either surgically or hormonally) Exclusion Criteria: * Patients with central nervous system metastases, except those patients who have had excision or radiotherapy and remain asymptomatic, off steroids and with no evidence of disease as shown by MRI for at least 6 months * Patients known to be HIV positive * Patients with active autoimmune disease * Patients involving concurrent anticancer drug therapy * Patients with unstable medical condition, such as uncontrolled diabetes mellitus or hypertension; active infections requiring systemic antibiotics, antivirals, or antifungals; clinical evidence of cardiac or pulmonary dysfunction including, but not limited to: unstable CHF, uncontrolled arrhythmias, unstable coagulation disorders, or recent myocardial infarction (within 6 months)
References
Publications (0)
Data not yet available
No reference posted for this study.