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Completed Phase 1Phase 2 Interventional Results available

Study of MDX-010 in Patients With Metastatic Hormone-Refractory Prostate Cancer

ClinicalTrials.gov ID: NCT00323882

Public ClinicalTrials.gov record NCT00323882. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 26, 2026, 10:39 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase I/II, Open-label, Dose-escalation Study of MDX-010 Administered Every 3 Weeks for 4 Doses in Patients With Metastatic Hormone-Refractory Prostate Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Multicenter study in which patients with metastatic hormone refractory prostate cancer (HRPC), who have not had previous chemotherapy or immunotherapy treatments, received MDX-010 every 3 weeks for 4 doses (12 weeks total duration of induction). MDX-010 was administered at escalating dosage levels of 3, 5, and 10 mg/kg/dose infusions. At least 6 patients were to be enrolled in each dosage level. Patients who tolerated and responded to treatment or who had stable disease for 3 months or longer and who subsequently progressed during the follow up phase of the study had the option to receive additional treatment with MDX-010, up to 4 cycles. Patients were followed in the study for response up to 2 years and were followed for survival status for up to 5 years after enrollment.

Study identification

NCT ID
NCT00323882
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Bristol-Myers Squibb
Industry
Enrollment
75 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 31, 2005
Primary completion
Aug 31, 2009
Completion
Jun 30, 2013
Last update posted
Aug 27, 2014

2006 – 2013

United States locations

U.S. sites
14
U.S. states
8
U.S. cities
12
Facility City State ZIP Site status
The Angeles Clinic and Research Institute Los Angeles California 11818 —
The Angeles Clinic and Research Institute Los Angeles California 90025 —
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California 94115 —
Yale University School of Medicine New Haven Connecticut 06520 —
Josephine Ford Cancer Center-Downriver Brownstown Michigan 48183 —
Henry Ford Medical Center-Fairlane Dearborn Michigan 48126 —
Henry Ford Hospital Detroit Michigan 48202-2689 —
Henry Ford Medical Center-West Bloomfield West Bloomfield Michigan 48322 —
Washington University School of Medicine St Louis Missouri 63110 —
Memorial Sloan-Kettering Cancer Center New York New York 10021 —
Carolina BioOncology Institute Huntersville North Carolina 28078 —
Oregon Health and Science University Portland Oregon 97239-3098 —
Seattle Cancer Care Alliance Seattle Washington 98109 —
University of Washington Medical Center Seattle Washington 98195 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00323882, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 27, 2014 · Synced Sep 26, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00323882 live on ClinicalTrials.gov.

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