Study of CEP-701 in Treatment of Prostate Cancer

This study has been completed.

First Received: April 15, 2004 Last Updated: September 14, 2005 History of Changes

Sponsor:	Cephalon
Information provided by:	Cephalon
ClinicalTrials.gov Identifier:	NCT00081601

Purpose

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

Condition	Intervention	Phase
Prostate Cancer	Drug: CEP-701	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label Phase 2 Study of Oral CEP-701 in Patients With Asymptomatic Hormone-Refractory Cancer With Rising Prostate Specific Antigen

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: CEP 701

U.S. FDA Resources

Further study details as provided by Cephalon:

Estimated Enrollment:	30
Study Start Date:	October 2003
Estimated Study Completion Date:	October 2004

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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has been withdrawn from antiandrogen therapy for at least 6 weeks prior to entering screening period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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00081601

Locations

United States, Maryland
Johns Hopkins
Baltimore, Maryland, United States, 21287

Sponsors and Collaborators

Cephalon

More Information

No publications provided

Study ID Numbers:	C0701a/203/ON/US
Study First Received:	April 15, 2004
Last Updated:	September 14, 2005
ClinicalTrials.gov Identifier:	NCT00081601 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cephalon:

prostate cancer
prostate specific antigen
PSA

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 25, 2009