Study of CEP-701 in Treatment of Prostate Cancer

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

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

Key facts

Study ID

NCT00081601

Run by

Cephalon

People needed

30

Starts

2004-03-01

Expected to finish

2005-06-01

Last updated by the study team

2012-08-24

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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• has been withdrawn from antiandrogen therapy for at least 6 weeks prior to entering screening period

You may not qualify if…

• 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

Where it is running

• Johns Hopkins — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.