Study of CEP-701 in Treatment of Prostate Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2005-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Prostate Cancer

Keywords

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prostate cancer prostate specific antigen PSA

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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CEP-701

Intervention Type DRUG

Eligibility Criteria

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* has been withdrawn from antiandrogen therapy for at least 6 weeks prior to entering screening period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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Johns Hopkins

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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C0701a/203/ON/US

Identifier Type: -

Identifier Source: org_study_id