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NCT02643667 · ClinicalTrials.gov registry record · Phase 2
Ibrutinib as Neoadjuvant Therapy in Localized Prostate Cancer
A Phase 2 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
NCT02643667: Completed Phase 2 study, sponsored by Washington University School of Medicine.
NCT02643667 is a Phase 2 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 27 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02643667, a Phase 2 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
Study Summary
30-40% of patients who undergo radical prostatetecomy (RP) with curative intent for their localized prostate cancer experience relapse of their disease. Thus, improved therapeutic approaches are needed in this patient population. Enhancing the patient's anti-tumor immune response prior to surgery may improve long-term outcomes following RP
Primary Outcome
* CTCAE v.4.0 * DLTs will be defined as any of the following that are attributable to ibrutinib. * Any grade 4 toxicity, including hematologic toxicities with the exception of lymphocytosis. Lymphocytosis, in the absence of clinical symptoms, is excluded from DLT, as this may be considered an on-target pharmacodynamics effect of BTK inhibition. * Any grade 3 toxicity. * Any recurrence of the same grade 3 toxicity. * Any delay of RP due to study-drug related toxicity. * Any complicatio
Interventions
- DRUG Ibrutinib
- PROCEDURE Radical prostatectomy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2016-07 |
| Est. Completion | 2023-04-12 |
| Phase | Phase 2 |
What the finished NCT02643667 record still lists
NCT02643667 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Ibrutinib is the first listed.
NCT02643667 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02643667 about?
NCT02643667 is a clinical study titled "Ibrutinib as Neoadjuvant Therapy in Localized Prostate Cancer". 30-40% of patients who undergo radical prostatetecomy (RP) with curative intent for their localized prostate cancer experience relapse of their disease. Thus, improved therapeutic approaches are needed in this patient population. Enhancing the patient's anti-tumor immune response prior to surgery ma...
What is the current status of trial NCT02643667?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2016-07. Estimated completion is 2023-04-12.
What interventions are being tested in trial NCT02643667?
The interventions under investigation include: Ibrutinib (DRUG), Radical prostatectomy (PROCEDURE).
Who is sponsoring clinical trial NCT02643667?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02643667's enrollment target sits among peer trials
27 1697th of 2000 higher than 293 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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