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NCT03188328 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, PK, Dosimetry, MTD and Preliminary Efficacy of Intra-lesionally Injected AvidinOX, Followed by IV Escalating Doses of [177Lu]DOTA-biotin in Pts With Injectable Solid Tumors or Lymphomas
A Phase 1 study, sponsored by Alfasigma S.p.A..
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT03188328 is a Phase 1 study that was terminated before completion, run by Alfasigma S.p.A.. The registered enrollment target is 3 participants.
The verdict
NCT03188328, a Phase 1 study, was terminated before completion, sponsored by Alfasigma S.p.A..
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
Local treatment of unresectable tumors is challenging, particularly with radioactivity. Current practice relies on external beam irradiation or on a variety of medical devices for brachytherapy. Both approaches proved useful in controlling tumor growth but are characterized by poor patient's compliance, significant side effects, high costs and technological complexity hampering wide-spread use. The use of AvidinOX for radionuclide therapy of inoperable cancer lesions will offer a number of advantages compared to current brachytherapy. In fact, the perfusion of a target tissue with AvidinOX, compared to current devices, will allow adapting the therapy to the tumor/organ shape, and it will also make it possible to delay the administration of radioactivity for several days which, according to pre-clinical studies, might be also divided up into repeated doses. AvidinOX linking stably to tissue proteins, does not exhibit the problem of seed migration which is associated with high morbidity. Based on previous findings with AvidinOX in combination with radionuclides in pre-clinical studies as well as data from the clinical use in liver metastases, it can be assumed that intralesional injections of AvidinOX followed by intravenous injections of 177Lu-ST2210 could be a safe and efficacious method for treating inoperable tumor lesions.
Interventions
- DRUG AvidinOX
- DRUG 177Lu-ST2210
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2017-08-07 |
| Est. Completion | 2019-07-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03188328
The ClinicalTrials.gov registry entry for NCT03188328 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alfasigma S.p.A., which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which AvidinOX is the first listed.
NCT03188328 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03188328 about?
NCT03188328 is a clinical study titled "Safety, Tolerability, PK, Dosimetry, MTD and Preliminary Efficacy of Intra-lesionally Injected AvidinOX, Followed by IV Escalating Doses of [177Lu]DOTA-biotin in Pts With Injectable Solid Tumors or Lymphomas". Local treatment of unresectable tumors is challenging, particularly with radioactivity. Current practice relies on external beam irradiation or on a variety of medical devices for brachytherapy. Both approaches proved useful in controlling tumor growth but are characterized by poor patient's complia...
What is the current status of trial NCT03188328?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2017-08-07. Estimated completion is 2019-07-01.
What interventions are being tested in trial NCT03188328?
The interventions under investigation include: AvidinOX (DRUG), 177Lu-ST2210 (DRUG).
Who is sponsoring clinical trial NCT03188328?
This trial is sponsored by Alfasigma S.p.A., which has 7 total clinical trials registered on ClinicalTrials.gov.
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