Study of CEP-701 in Treatment of Prostate Cancer - Tabular View

Tracking Information
First Received Date ^ICMJE	April 15, 2004
Last Updated Date	September 14, 2005
Start Date ^ICMJE	October 2003
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00081601 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study of CEP-701 in Treatment of Prostate Cancer
Official Title ^ICMJE	An Open-Label Phase 2 Study of Oral CEP-701 in Patients With Asymptomatic Hormone-Refractory Cancer With Rising Prostate Specific Antigen
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.
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Prostate Cancer
Intervention ^ICMJE	Drug: CEP-701
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	30
Completion Date	October 2004
Primary Completion Date
Eligibility Criteria ^ICMJE	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bone and CT scans has increasing serum PSA concentrations life expectancy of at least 3 months ECOG of 0 or 1 has been withdrawn from antiandrogen therapy for at least 6 weeks prior to entering screening period Exclusion Criteria: has asymptomatic disease has active GI ulceration or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
Gender	Male
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00081601
Responsible Party
Study ID Numbers ^ICMJE	C0701a/203/ON/US
Study Sponsor ^ICMJE	Cephalon
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Cephalon
Verification Date	September 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP