Study of CEP-701 in Treatment of Prostate Cancer

Cephalon

Status and phase

Completed

Phase 2

Conditions

Prostate Cancer

Treatments

Drug: CEP-701

Study type

Interventional

Funder types

Industry

Identifiers

NCT00081601

C0701a/203/ON/US

Details and patient eligibility

About

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

Full 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.

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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has been withdrawn from antiandrogen therapy for at least 6 weeks prior to entering screening period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