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NCT05949099 · ClinicalTrials.gov registry record · Phase 2
Study of Cryoablation and Nirogacestat for Desmoid Tumor
A Phase 2 study of Desmoid Tumor, sponsored by Nam Bui.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT05949099: Recruiting Phase 2 study of Desmoid Tumor, sponsored by Nam Bui.
NCT05949099 is a Phase 2 study of Desmoid Tumor that is actively recruiting participants, run by Nam Bui. The registered enrollment target is 28 participants, below the 83-participant average among 4 other Desmoid Tumor trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05949099, a Phase 2 study of Desmoid Tumor, is actively recruiting participants, sponsored by Nam Bui.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary purpose of this protocol is Systemic therapy with oral study agent, nirogacestat, followed by a single cryoablation procedure.
Primary Outcome
Clinical benefit (CB) is defined as the number of participants assessed with a complete response (CR), partial response (PR), or stable disease (SD) within 1 year and with no evidence of loss of response nor progression within that year. Response \& progression will be assessed according to the Revised Response Evaluation Criteria in Solid Tumors (RECIST)v1.1, as follows: RECIST v1.1: * CR=Disappearance of all lesions * PR=≥30% decrease in diameter of target lesions * Progressive disease (PD)=
Conditions Studied
Interventions
- PROCEDURE Cryoablation
- DRUG Nirogacestat
Study Locations (1)
California
- Stanford University - Palo Alto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2023-08-15 |
| Est. Completion | 2028-02-01 |
| Phase | Phase 2 |
What NCT05949099 shows while recruiting
NCT05949099 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 83-participant average among 4 other Desmoid Tumor trials with a reported enrollment target (66% lower).
The record links to 1 condition, with Desmoid Tumor appearing as the primary indexed condition, and to 2 interventions - of which Cryoablation is the first listed.
NCT05949099 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05949099 about?
NCT05949099 is a clinical study titled "Study of Cryoablation and Nirogacestat for Desmoid Tumor". The primary purpose of this protocol is Systemic therapy with oral study agent, nirogacestat, followed by a single cryoablation procedure.
What is the current status of trial NCT05949099?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2023-08-15. Estimated completion is 2028-02-01.
What conditions does trial NCT05949099 study?
This clinical trial studies the following conditions: Desmoid Tumor.
What interventions are being tested in trial NCT05949099?
The interventions under investigation include: Cryoablation (PROCEDURE), Nirogacestat (DRUG).
Who is sponsoring clinical trial NCT05949099?
This trial is sponsored by Nam Bui, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05949099 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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