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NCT00323882 · ClinicalTrials.gov registry record · Phase 1
Study of MDX-010 in Patients With Metastatic Hormone-Refractory Prostate Cancer
A Phase 1 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
NCT00323882 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 75 participants.
The verdict
NCT00323882, a Phase 1 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG MDX-010
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2006-01 |
| Est. Completion | 2013-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00323882
The ClinicalTrials.gov registry entry for NCT00323882 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which MDX-010 is the first listed.
NCT00323882 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00323882 about?
NCT00323882 is a clinical study titled "Study of MDX-010 in Patients With Metastatic Hormone-Refractory Prostate Cancer". 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 o...
What is the current status of trial NCT00323882?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2006-01. Estimated completion is 2013-07.
What interventions are being tested in trial NCT00323882?
The interventions under investigation include: MDX-010 (DRUG).
Who is sponsoring clinical trial NCT00323882?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
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