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NCT03545165 · ClinicalTrials.gov registry record · Phase 1
177Lu-J591 and 177Lu-PSMA-617 Combination for mCRPC
A Phase 1 study, sponsored by Weill Medical College of Cornell University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT03545165 is a Phase 1 study that was terminated before completion, run by Weill Medical College of Cornell University. The registered enrollment target is 6 participants.
The verdict
NCT03545165, a Phase 1 study, was terminated before completion, sponsored by Weill Medical College of Cornell University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
Phase I dose escalation study with combination of 177Lu-J591 and 177Lu-PSMA-617 using a dose-fractionated regimen will be performed in patients with documented progressive metastatic CRPC. The cumulative 177Lu-J591 dose for each subject will be 2.7 GBq/m2 (73 mCi/m2) of 177Lu with 20 mg J591 and the cumulative 177Lu-PSMA-617 dose for each subject will vary (depending on the Cohort) from 3.7 GBq (100 mCi) to 18.5 GBq (500 mCi). The 177Lu-PSMA-617 dose will be escalated in up to 6 different dose levels (3+3 dose-escalation study / de-escalation design). For the phase II portion, a minimum number of 14 patients will be enrolled at MTD (including those enrolled at MTD in Phase I) and a maximum of 24.
Interventions
- DRUG 177Lu-PSMA-617
- DRUG 177Lu-J591
- DRUG 68Ga-PSMA-HBED-CC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2018-04-18 |
| Est. Completion | 2020-07-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03545165
The ClinicalTrials.gov registry entry for NCT03545165 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which 177Lu-PSMA-617 is the first listed.
NCT03545165 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03545165 about?
NCT03545165 is a clinical study titled "177Lu-J591 and 177Lu-PSMA-617 Combination for mCRPC". Phase I dose escalation study with combination of 177Lu-J591 and 177Lu-PSMA-617 using a dose-fractionated regimen will be performed in patients with documented progressive metastatic CRPC. The cumulative 177Lu-J591 dose for each subject will be 2.7 GBq/m2 (73 mCi/m2) of 177Lu with 20 mg J591 and the...
What is the current status of trial NCT03545165?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2018-04-18. Estimated completion is 2020-07-15.
What interventions are being tested in trial NCT03545165?
The interventions under investigation include: 177Lu-PSMA-617 (DRUG), 177Lu-J591 (DRUG), 68Ga-PSMA-HBED-CC (DRUG).
Who is sponsoring clinical trial NCT03545165?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
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