Study of CEP-701 in Treatment of Prostate Cancer

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cephalon

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• has been withdrawn from antiandrogen therapy for at least 6 weeks prior to entering screening period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