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Study of CEP-701 in Treatment of Prostate Cancer

Sponsor
Cephalon (Industry)
Overall Status
Completed
CT.gov ID
NCT00081601
Collaborator
(none)
30
Enrollment
1
Location
15
Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label Phase 2 Study of Oral CEP-701 in Patients With Asymptomatic Hormone-Refractory Cancer With Rising Prostate Specific Antigen
Study Start Date :
Mar 1, 2004
Actual Primary Completion Date :
May 1, 2005
Actual Study Completion Date :
Jun 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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    • has been withdrawn from antiandrogen therapy for at least 6 weeks prior to entering screening period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

    Locations

    Site City State Country Postal Code
    1 Johns Hopkins Baltimore Maryland United States 21287

    Sponsors and Collaborators

    • Cephalon

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cephalon
    ClinicalTrials.gov Identifier:
    NCT00081601
    Other Study ID Numbers:
    • C0701a/203/ON/US
    First Posted:
    Apr 19, 2004
    Last Update Posted:
    Aug 24, 2012
    Last Verified:
    Aug 1, 2012
    Keywords provided by Cephalon
    prostate cancer
    prostate specific antigen
    PSA
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Aug 24, 2012