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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: Clinical Trial Phase 1 study, sponsored by Orano Med.
NCT03466216 is a Phase 1 study that was terminated before completion, run by Orano Med. The registered enrollment target is 33 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
DLT is defined as non-hematological toxicity - all Grade 4 and Grade 3 (except alk. phos.) that is not responsive to NMT 72 hours of supportive care - and all hematological toxicity that does not recover to NMT than Grade 2 within 8 wks of dose administration.
Interventions
- DRUG AlphaMedix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2018-02-05 |
| Est. Completion | 2023-04-06 |
| Phase | Phase 1 |
Why NCT03466216 stopped before completion
NCT03466216 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 1 intervention - of which AlphaMedix is the first listed.
NCT03466216 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03466216's enrollment target sits among peer trials
33 1280th of 2000 higher than 705 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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