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NCT01384253 · ClinicalTrials.gov registry record · Phase 1
Safety Study of ²¹²Pb-TCMC-Trastuzumab Radio Immunotherapy
A Phase 1 study, sponsored by Orano Med.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT01384253 is a Phase 1 study that has completed, run by Orano Med. The registered enrollment target is 18 participants.
The verdict
NCT01384253, a Phase 1 study, has completed, sponsored by Orano Med.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
Monoclonal antibodies can transport and deliver radioactive elements capable of releasing sufficient amounts of energy to destroy tumor cells. In this clinical trial, we will study alpha particle radio immunotherapy using lead-212 (²¹²Pb), an isotope with a short path length targeted to malignant cells by the trastuzumab antibody, as a potential treatment for metastatic diseases. This Phase I trial is designed to determine the toxicity profile of ²¹²Pb-TCMC-Trastuzumab, its dose-limiting toxicities, and its anti-tumor effects in patients with HER-2 positive intraperitoneal cancers.
Interventions
- BIOLOGICAL trastuzumab
- OTHER ²¹²Pb-TCMC-Trastuzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2011-07 |
| Est. Completion | 2016-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01384253
The ClinicalTrials.gov registry entry for NCT01384253 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Orano Med, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which trastuzumab is the first listed.
NCT01384253 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01384253 about?
NCT01384253 is a clinical study titled "Safety Study of ²¹²Pb-TCMC-Trastuzumab Radio Immunotherapy". Monoclonal antibodies can transport and deliver radioactive elements capable of releasing sufficient amounts of energy to destroy tumor cells. In this clinical trial, we will study alpha particle radio immunotherapy using lead-212 (²¹²Pb), an isotope with a short path length targeted to malignant ce...
What is the current status of trial NCT01384253?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2011-07. Estimated completion is 2016-07.
What interventions are being tested in trial NCT01384253?
The interventions under investigation include: trastuzumab (BIOLOGICAL), ²¹²Pb-TCMC-Trastuzumab (OTHER).
Who is sponsoring clinical trial NCT01384253?
This trial is sponsored by Orano Med, which has 4 total clinical trials registered on ClinicalTrials.gov.
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