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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: Completed Phase 1 study, sponsored by Orano Med.
NCT01384253 is a Phase 1 study that has completed, run by Orano Med. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Adverse events considered dose limiting toxicity: * Grade 3 elevations of ALP, bilirubin, ALT, or AST lasting ≥7 days * Grade 3 elevations of serum creatinine within 6 weeks of treatment * Grade 2 elevations of serum creatinine lasting ≥7 days that occur after 6 weeks * Grade 3 proteinuria * Any other Grade 3 or 4 non-hematologic toxicity * Grade 4 neutropenia lasting ≥7 days or febrile neutropenia of any duration * Grade 3 thrombocytopenia that fails to recover to ≤ Grade 2 at 6 weeks * Grade
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 |
What the finished NCT01384253 record still lists
NCT01384253 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which trastuzumab is the first listed.
NCT01384253 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01384253's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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