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NCT03466216 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Study of AlphaMedix™ in Adult Subjects With SSTR (+) NET
A Phase 1 study, sponsored by Orano Med.
- Terminated
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT03466216 is a Phase 1 study that was terminated before completion, run by Orano Med. The registered enrollment target is 33 participants.
The verdict
NCT03466216, a Phase 1 study, was terminated before completion, sponsored by Orano Med.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study Summary
AlphaMedix™ (²¹²Pb-DOTAMTATE) is a radiotherapeutic drug indicated in subjects with unresectable, metastatic somatostatin receptor (SSTR) positive neuroendocrine tumors (NETs). Because 212Pb is an in vivo generator of alpha particles, it is particularly suitable for SSTR therapy applications. This drug addresses an unmet need in the field of peptide receptor radionuclide therapy (PRRT) for NETs. Substitution of an alpha emitter (²¹²Pb) for the beta emitters currently being used (i.e., 177Lu or 90Y) will provide significantly higher Linear Energy Transfer (LET) and a shorter path length. Higher LET particles should cause more tumor cell death. Shorter path length should result in less collateral damage of the normal tissue and therefore less side effects for subjects receiving the drug.
Interventions
- DRUG AlphaMedix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2018-02-05 |
| Est. Completion | 2023-04-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03466216
The ClinicalTrials.gov registry entry for NCT03466216 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 33 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 1 intervention - of which AlphaMedix is the first listed.
NCT03466216 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03466216 about?
NCT03466216 is a clinical study titled "Phase 1 Study of AlphaMedix™ in Adult Subjects With SSTR (+) NET". AlphaMedix™ (²¹²Pb-DOTAMTATE) is a radiotherapeutic drug indicated in subjects with unresectable, metastatic somatostatin receptor (SSTR) positive neuroendocrine tumors (NETs). Because 212Pb is an in vivo generator of alpha particles, it is particularly suitable for SSTR therapy applications. This ...
What is the current status of trial NCT03466216?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2018-02-05. Estimated completion is 2023-04-06.
What interventions are being tested in trial NCT03466216?
The interventions under investigation include: AlphaMedix (DRUG).
Who is sponsoring clinical trial NCT03466216?
This trial is sponsored by Orano Med, which has 4 total clinical trials registered on ClinicalTrials.gov.
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