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NCT05797246 · ClinicalTrials.gov registry record · Phase 2
Bevacizumab in Adults With Recurrent Respiratory Papillomatosis (RRP)
A Phase 2 study of Neoplasms and Infections, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT05797246: Active Phase 2 study of Neoplasms and Infections, sponsored by National Cancer Institute (NCI).
NCT05797246 is a Phase 2 study of Neoplasms and Infections that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 21 participants, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05797246, a Phase 2 study of Neoplasms and Infections, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Recurrent respiratory papillomatosis (RRP) is a rare disease that causes wart-like growths in the airways. These growths come back when removed; some people may need 2 or more surgeries per year to keep their airways clear. Better treatments are needed. Objective: To see if a drug called bevacizumab can reduce the number of surgeries needed in people with RRP. Eligibility: People aged 18 and older with recurrent RRP; they must need surgery to remove the growths in their airways. Design: Participants will be screened. Their ability to breathe and speak will be evaluated. They will have an endoscopy: a flexible tube with a light and camera will be inserted into their nose and throat. They will have a test of their heart function and imaging scans of their chest. Participants will have surgery to remove the growths in their airways. Bevacizumab is given through a small tube placed in a vein in the arm. After the surgery, participants will receive 11 doses of this drug: every 3 weeks for 3 doses, and then every 6 weeks for 8 more doses. They will come to the clinic for each dose; each visit will be about 8 hours. Tissue samples of the growths will be collected after the second treatment; this will be done under general anesthesia. Participants may undergo apheresis: Blood will be drawn from a needle in an arm. The blood will pass through a machine that separates out the cells needed for the study. The remaining blood will be returned to the body through a second needle. Follow-up will continue for 1 year after the last treatment....
Primary Outcome
Determined by measuring the mean duration between successive clinically indicated surgeries in the 12 months during treatment for that participant and determining whether that duration is longer than the mean duration between successive clinically indicated surgeries in the 12 months prior to treatment by one month or more. This fraction of participants who are classified as having a success will be reported along with a 95% confidence interval.
Conditions Studied
Interventions
- DRUG Bevacizumab
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2023-08-02 |
| Est. Completion | 2029-01-01 |
| Phase | Phase 2 |
What the registry record for NCT05797246 still lists
NCT05797246 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (99% lower).
The record links to 10 conditions, with Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which Bevacizumab is the first listed.
NCT05797246 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05797246 about?
NCT05797246 is a clinical study titled "Bevacizumab in Adults With Recurrent Respiratory Papillomatosis (RRP)". Background: Recurrent respiratory papillomatosis (RRP) is a rare disease that causes wart-like growths in the airways. These growths come back when removed; some people may need 2 or more surgeries per year to keep their airways clear. Better treatments are needed. Objective: To see if a drug cal...
What is the current status of trial NCT05797246?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2023-08-02. Estimated completion is 2029-01-01.
What conditions does trial NCT05797246 study?
This clinical trial studies the following conditions: Neoplasms, Infections, Pathologic Processes, Respiratory Tract Diseases, Virus Diseases.
What interventions are being tested in trial NCT05797246?
The interventions under investigation include: Bevacizumab (DRUG).
Who is sponsoring clinical trial NCT05797246?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05797246 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05797246's enrollment target sits among peer trials
21 145th of 158 higher than 14 of 158 other Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms 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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