At a glance
ClinicalIndex Comparison Record- ✓Histologically proven adenocarcinoma of prostate with documented PSA progression (≥3 consecutive rises, last value ≥4 ng/mL, ≥1 week apart) despite castration or during non-hormonal chemotherapy
- ✓Either no prior chemotherapy for advanced/metastatic disease (except mitoxantrone or estramustine) OR failure of ≤1 prior tubulin-binding chemotherapy regimen (e.g., docetaxel)
- ✓Patients on antiandrogen must have ≥4 weeks (≥6 weeks for nilutamide/bicalutamide) since withdrawal to document progression
- ✓Age ≥18 years
- ✕Chemotherapy, radiation, or experimental therapy within 4 weeks of E7389 start
- ✕Radiation encompassing ≥30% of marrow or radioactive strontium treatment
- ✕Therapeutic anticoagulation with warfarin or related compounds (mini-dose permitted)
- ✕Severe/uncontrolled intercurrent illness or infection
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Multicenter, Open Label, Two Stage Design Study Evaluating E7389 in Patients With Hormone Refractory Prostate Cancer With Advanced and/or Metastatic Disease Stratified by Prior Chemotherapy
In Brief
A Phase 2 clinical trial evaluating E7389 for Prostate Cancer. Completed, enrolled 108 participants across 18 sites.
Detailed Summary
This is a multi-centre, phase II, open-label, two-stage design, single-arm study in patients with hormone-refractory prostate cancer (HRPC) with advanced (rising PSA) and/or metastatic disease and who have had prior anti-androgen therapy. The study will further explore the efficacy of E7389 by enrollment of patients into two strata: those who have had no prior systemic chemotherapy for their disease (except for mitoxantrone and estramustine), and those who failed no more than one previous chemotherapeutic regimen with tubulin-binding agents such as docetaxel.
Study Details
Timeline
Interventions
Intravenous 1.4 mg/m2 on a 3-week course.