An Open-Label Phase 2 Study of Oral CEP-701 in Patients With Asymptomatic Hormone-Refractory Cancer With Rising Prostate Specific Antigen

Cephalon1 site in 1 country30 target enrollmentMarch 2004

ConditionsProstate Cancer

DrugsCEP-701

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: Cephalon
Enrollment: 30
Locations: 1
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine the proportion of patients with a serological prostate specific antigen (PSA) by day 85.

Detailed Description

A serological PSA response is defined as a reduction from baseline PSA serum concentration of at least 50%, which is confirmed by a second PSA value 28 or more days later.

Registry

clinicaltrials.gov

Start Date

March 2004

End Date

June 2005

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Cephalon

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•at least 18 yrs of age
•diagnosis of adenocarcinoma of the prostate
•no detectable metastatic disease as assessed by bone and CT scans
•has increasing serum PSA concentrations
•life expectancy of at least 3 months
•ECOG of 0 or 1
•has been withdrawn from antiandrogen therapy for at least 6 weeks prior to entering screening period

Exclusion Criteria

•has asymptomatic disease
•has active GI ulceration or bleeding
•has been treated with non-hormonal systemic anticancer therapy or has received radiation within 4 weeks of baseline visit
•bilirubin \>2x ULN or ALT or AST \>2xULN or serum creatinine \>1.5mg/dL
•hemoglobin \<9g/dL or platelets below 100,000/uL or ANC below 1500/uL
•receiving treatment for HIV with protease inhibitors
•has had prior malignancy within past 5 yrs with exception of resected basal or squamous cell carcinomas of the skin
•has used investigational drug with previous one month