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

Eisai Inc.17 sites in 1 country108 target enrollmentJanuary 2006

ConditionsProstate Cancer

InterventionsE7389

DrugsE7389

Overview

Phase: Phase 2
Intervention: E7389
Conditions: Prostate Cancer
Sponsor: Eisai Inc.
Enrollment: 108
Locations: 17
Primary Endpoint: Objective Prostate Specific Antigen (PSA) Response Rate Based on Bubley Criteria
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

January 2006

End Date

January 2008

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Eisai Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

1

With stratification

Intervention: E7389

Outcomes

Primary Outcomes

Objective Prostate Specific Antigen (PSA) Response Rate Based on Bubley Criteria

Time Frame: 12 months

Bubley Criteria: Patients must have progressive disease to enter study. For outcomes, PSA response must show at least 50% decrease. Duration of response is the time from \>50% decrease from baseline to when there is a 50% decrease in nadir. PSA progressive disease- 25% increase from baseline or increase of 5 ng/mL along with measureable disease Stable disease- decline of less than 50% and not more than 25% increase.

Secondary Outcomes

Progression Free Survival(12 months)
Duration of Prostate Specific Antigen Response Based on Bubley Criteria(12 months.)
Overall Survival(12 months)
Best Objective Tumor Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria(12 months)