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NCT05743621 · ClinicalTrials.gov registry record · Phase 1
Study of TVB-2640 in Men With Metastatic Castration-Resistant Prostate Cancer
A Phase 1 study of Prostatic Neoplasms, Castration-Resistant, sponsored by Weill Medical College of Cornell University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT05743621: Recruiting Phase 1 study of Prostatic Neoplasms, Castration-Resistant, sponsored by Weill Medical College of Cornell University.
NCT05743621 is a Phase 1 study of Prostatic Neoplasms, Castration-Resistant that is actively recruiting participants, run by Weill Medical College of Cornell University. The registered enrollment target is 30 participants, below the 738-participant average among 10 other Prostatic Neoplasms, Castration-Resistant trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05743621, a Phase 1 study of Prostatic Neoplasms, Castration-Resistant, is actively recruiting participants, sponsored by Weill Medical College of Cornell University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine what effects (good and bad) Enzalutamide and TVB-2640 have in the treatment of prostate cancer whose prostate cancer has spread to other parts of their body and that has not gotten better with previous treatment. This study is a Phase I clinical trial. Phase I clinical trials test the side effects of an investigational drug or an investigational combination with another drug. "Investigational" means that the drug is still being studied and research doctors are trying to find out more about it. Although Enzalutamide is already being used to treat men with prostate cancer, combining Enzalutamide with TVB-2640 together in patients with prostate cancer is considered experimental. This research study is being done because additional effective treatments are needed for prostate cancer that has spread and is growing despite hormone suppression. By doing this study, the investigators hope to learn if combining Enzalutamide with TVB-2640 can be done safely. Participation in this research will last about 12 to 24 months after enrollment.
Primary Outcome
The maximum tolerated dose (MTD) is defined as the highest dose level at which ≤1 patient experiences a dose-limiting toxicity, as defined in the protocol (DLT). Once all the patients are accrued, the MTD will be determined by performing isotonic regression on the pooled data.
Conditions Studied
Interventions
- DRUG Enzalutamide
- DRUG TVB-2640
Study Locations (1)
New York
- Weill Cornell Medicine/NewYork-Presbyterian Hospital - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-11-20 |
| Est. Completion | 2029-01-25 |
| Phase | Phase 1 |
What NCT05743621 shows while recruiting
NCT05743621 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 738-participant average among 10 other Prostatic Neoplasms, Castration-Resistant trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Prostatic Neoplasms, Castration-Resistant appearing as the primary indexed condition, and to 2 interventions - of which Enzalutamide is the first listed.
NCT05743621 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05743621 about?
NCT05743621 is a clinical study titled "Study of TVB-2640 in Men With Metastatic Castration-Resistant Prostate Cancer". The purpose of this study is to determine what effects (good and bad) Enzalutamide and TVB-2640 have in the treatment of prostate cancer whose prostate cancer has spread to other parts of their body and that has not gotten better with previous treatment. This study is a Phase I clinical trial. Phase...
What is the current status of trial NCT05743621?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2023-11-20. Estimated completion is 2029-01-25.
What conditions does trial NCT05743621 study?
This clinical trial studies the following conditions: Prostatic Neoplasms, Castration-Resistant.
What interventions are being tested in trial NCT05743621?
The interventions under investigation include: Enzalutamide (DRUG), TVB-2640 (DRUG).
Who is sponsoring clinical trial NCT05743621?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05743621 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05743621's enrollment target sits among peer trials
30 10th of 10 higher than 1 of 10 other Prostatic Neoplasms, Castration-Resistant trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostatic Neoplasms, Castration-Resistant 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.
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