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Study of CEP-701 in Treatment of Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CEP-701
Sponsored by
Cephalon
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, prostate specific antigen, PSA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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bone and CT scans has increasing serum PSA concentrations life expectancy of at least 3 months ECOG of 0 or 1 has been withdrawn from antiandrogen therapy for at least 6 weeks prior to entering screening period Exclusion Criteria: has asymptomatic disease has active GI ulceration or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

Sites / Locations

  • Johns Hopkins

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 15, 2004
Last Updated
August 22, 2012
Sponsor
Cephalon
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1. Study Identification

Unique Protocol Identification Number
NCT00081601
Brief Title
Study of CEP-701 in Treatment of Prostate Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cephalon

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer, prostate specific antigen, PSA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
CEP-701

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of CEP-701 in Treatment of Prostate Cancer

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