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NCT03490838 · ClinicalTrials.gov registry record · Phase 1
177Lu-PSMA-R2 in Patients With PSMA Positive Progressive, Metastatic, Castration Resistant Prostate Cancer
A Phase 1 study, sponsored by Advanced Accelerator Applications.
- Terminated
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT03490838 is a Phase 1 study that was terminated before completion, run by Advanced Accelerator Applications. The registered enrollment target is 27 participants.
The verdict
NCT03490838, a Phase 1 study, was terminated before completion, sponsored by Advanced Accelerator Applications.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
This Phase 1/2 study is intended to investigate the safety, tolerability, and radiation dosimetry of 177Lu-PSMA-R2 and further assess preliminary efficacy data in patients with metastatic castration-resistant prostate cancer (mCRPC). The Phase 1 portion of the study will determine the recommended dose of 177Lu-PSMA-R2 for radio-ligand therapy (RLT) of mCRPC, and the Phase 2 portion will expand into approximately 60 patients documenting the preliminary activity (anti-tumor response) of repeated treatments administered, continuing safety assessments and collecting QoL data.
Interventions
- DRUG 177Lu-PSMA-R2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2018-05-24 |
| Est. Completion | 2022-06-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03490838
The ClinicalTrials.gov registry entry for NCT03490838 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Advanced Accelerator Applications, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which 177Lu-PSMA-R2 is the first listed.
NCT03490838 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03490838 about?
NCT03490838 is a clinical study titled "177Lu-PSMA-R2 in Patients With PSMA Positive Progressive, Metastatic, Castration Resistant Prostate Cancer". This Phase 1/2 study is intended to investigate the safety, tolerability, and radiation dosimetry of 177Lu-PSMA-R2 and further assess preliminary efficacy data in patients with metastatic castration-resistant prostate cancer (mCRPC). The Phase 1 portion of the study will determine the recommended do...
What is the current status of trial NCT03490838?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2018-05-24. Estimated completion is 2022-06-02.
What interventions are being tested in trial NCT03490838?
The interventions under investigation include: 177Lu-PSMA-R2 (DRUG).
Who is sponsoring clinical trial NCT03490838?
This trial is sponsored by Advanced Accelerator Applications, which has 8 total clinical trials registered on ClinicalTrials.gov.
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