Study of CEP-701 in Treatment of Prostate Cancer
Phase 2
Completed
- Conditions
- Prostate Cancer
- Registration Number
- NCT00081601
- Lead Sponsor
- Cephalon
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 30
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- has been withdrawn from antiandrogen therapy for at least 6 weeks prior to entering screening period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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Johns Hopkins
🇺🇸Baltimore, Maryland, United States