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NCT02552394 · ClinicalTrials.gov registry record · Phase 1
J591 in Patients With Advanced Prostate Cancer and Unfavorable Circulating Tumor Cell Counts
A Phase 1 study, sponsored by Weill Medical College of Cornell University.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT02552394: Completed Phase 1 study, sponsored by Weill Medical College of Cornell University.
NCT02552394 is a Phase 1 study that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02552394, a Phase 1 study, has completed, sponsored by Weill Medical College of Cornell University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
This clinical trial is for men with advanced prostate cancer that may have spread to other parts of the body. Currently, once prostate cancer cells have spread from the prostate to other organs it is not treatable by surgery. The purpose of this study is to treat patients with an experimental antibody (i.e. that has not been FDA approved) called J591 that attaches itself to a special protein on cancer cells called PSMA to try to eliminate these cancer cells (called circulating tumor cells) from the circulation. In the initial phase of the study, 6 participants will receive the experimental J591 treatment. Routine blood tests, research blood tests, physical exam will be performed at each visit. Participants will also be asked to complete a questionnaire about how they are feeling. Participants will have a radiographic scan every 3 months to check the status of their disease. Participants who tolerate the treatment well may be re-treated at the same level every 3 months, and may continue on treatment as long as they are responding to therapy and not experiencing unacceptable side effects.
Primary Outcome
Determine the effect of mAb Hu-J591 on reducing circulating tumor cells (CTCs) from \> 5/7.5 mL of whole blood to \< 5/7.5 mL of whole blood in metastatic prostate cancer (PC) with elevated baseline CTC count and to identify the least effective dose that clears CTCs.
Interventions
- DRUG huJ591
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2015-07 |
| Est. Completion | 2021-01-03 |
| Phase | Phase 1 |
What the finished NCT02552394 record still lists
NCT02552394 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which huJ591 is the first listed.
NCT02552394 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02552394 about?
NCT02552394 is a clinical study titled "J591 in Patients With Advanced Prostate Cancer and Unfavorable Circulating Tumor Cell Counts". This clinical trial is for men with advanced prostate cancer that may have spread to other parts of the body. Currently, once prostate cancer cells have spread from the prostate to other organs it is not treatable by surgery. The purpose of this study is to treat patients with an experimental antib...
What is the current status of trial NCT02552394?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2015-07. Estimated completion is 2021-01-03.
What interventions are being tested in trial NCT02552394?
The interventions under investigation include: huJ591 (DRUG).
Who is sponsoring clinical trial NCT02552394?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02552394's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 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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