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NCT03177460 · ClinicalTrials.gov registry record · Phase 1
Daratumumab or FMS Inhibitor JNJ-40346527 Before Surgery in Treating Patients With High-Risk, Resectable Localized or Locally Advanced Prostate Cancer
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT03177460: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT03177460 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. 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
NCT03177460, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects of daratumumab or FMS inhibitor JNJ-40346527 before surgery in treating patients with high-risk prostate cancer that can be removed by surgery and has not spread to other parts of the body or has spread to nearby tissue or lymph nodes. Immunotherapy with monoclonal antibodies, such as daratumumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spreadFMS inhibitor JNJ-40346527 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving daratumumab or FMS inhibitor JNJ-40346527 before surgery may work better in treating patients with prostate cancer.
Primary Outcome
Will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Will be recorded for all patients, recording name, grade, start and end dates, attribution to study drug, and whether the event was alleviated or controlled with relevant appropriate care similar to Phase I trials.
Interventions
- PROCEDURE Radical Prostatectomy
- BIOLOGICAL Daratumumab
- DRUG FMS Inhibitor JNJ-40346527
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2017-06-07 |
| Est. Completion | 2024-01-30 |
| Phase | Phase 1 |
What the finished NCT03177460 record still lists
NCT03177460 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 3 interventions - of which Radical Prostatectomy is the first listed.
NCT03177460 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03177460 about?
NCT03177460 is a clinical study titled "Daratumumab or FMS Inhibitor JNJ-40346527 Before Surgery in Treating Patients With High-Risk, Resectable Localized or Locally Advanced Prostate Cancer". This phase I trial studies the side effects of daratumumab or FMS inhibitor JNJ-40346527 before surgery in treating patients with high-risk prostate cancer that can be removed by surgery and has not spread to other parts of the body or has spread to nearby tissue or lymph nodes. Immunotherapy with m...
What is the current status of trial NCT03177460?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2017-06-07. Estimated completion is 2024-01-30.
What interventions are being tested in trial NCT03177460?
The interventions under investigation include: Radical Prostatectomy (PROCEDURE), Daratumumab (BIOLOGICAL), FMS Inhibitor JNJ-40346527 (DRUG).
Who is sponsoring clinical trial NCT03177460?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03177460'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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