ABX-EGF (a Monoclonal Antibody) Given to Patients With Prostate Cancer With or Without Tumor in Other Parts of the Body - Tabular View

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ABX-EGF (a Monoclonal Antibody) Given to Patients With Prostate Cancer With or Without Tumor in Other Parts of the Body

This study has been completed.

Study NCT00061126. Last updated on June 23, 2005. Information provided by Abgenix

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	ABX-EGF (a Monoclonal Antibody) Given to Patients With Prostate Cancer With or Without Tumor in Other Parts of the Body
Official Title ^†	A Clinical Trial Evaluating the Safety and Efficacy of ABX-EGF in Patients With Hormone Resistant Prostate Cancer With or Without Metastasis
Brief Summary	A clinical trial examining the safety and effectiveness of ABX-EGF when given to patients with prostate cancer with or without tumor in other parts of the body. Patients will be treated for a maximum of 48 doses (6 treatment courses; 8 doses per course) or until evidence of progressive disease.
Detailed Description
Study Phase	Phase II
Study Type ^†	Interventional
Study Design ^†	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Prostate Cancer
Intervention ^†	Drug: ABX-EGF
MEDLINE PMIDs
Links

Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†	50
Start Date ^†	April 2003
Completion Date
Eligibility Criteria ^†	Inclusion Criteria: Male 18 years of age or older Has tumor tissue available for diagnostics Failed front line luteinizing hormone-releasing hormone analogue (LHRH) such as leuprolide or goserelin, or failed orchiectomy, as evidenced by disease progression. Patients must continue on a LHRH analogue (unless the patient had an orchiectomy) throughout the course of the study ECOG score of 0 or 1 Exclusion Criteria: Any prior chemotherapy for prostate cancer besides hormonal therapy (including no prior EGFr targeting agent) Prior history of cancer other than prostate carcinoma within the past 5 years that has required treatment or been active (prior basal cell carcinoma is allowed) Known to be HIV positive Myocardial infarction within one year prior to entering the study
Gender	Male
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00061126
Organization ID	ABX-0310
Secondary IDs ^††	ABX-EGF
Study Sponsor ^†	Abgenix
Collaborators ^††	Immunex Corporation
Investigators ^†
Information Provided By	Abgenix
Verification Date	September 2004
First Received Date ^†	May 21, 2003
Last Updated Date	June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.