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.
| Condition(s) | Desmoid Tumor |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | The primary purpose of this protocol is Systemic therapy with oral study agent, nirogacestat, followed by a single cryoablation procedure. |
| Who can participate | Inclusion Criteria: 1. Histologically-confirmed diagnosis of desmoid tumor (DT) that is progressing (by RECIST criteria over the past 12 months) or symptomatic (as defined by change in pain regimen or impairment of activities of daily living (ADLs), or at investigator discretion). Note: Must have diagnosis of desmoid tumor on pathology report. 2. Desmoid tumor is 50 to \<75% cryoablatable. Tumors that are 50 to \<75% (volume) ablatable in a single session are characterized by: 1. Proximity (\< 1 cm) to critical structures, such as nerves, vessels, bowel, or skin, at risk of injury during ablation, despite hydrodissection 2. Large size ( \> 100 mL) 3. Complex shape, such that parts of the tumor cannot be reached from a single approach or subject position 4. Thin, infiltrative components, wh |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Nam Bui |
| Locations | Palo Alto, California, United States |
| Start date | 2023-08-15 |
| NCT ID | NCT05949099 |
| Official listing | https://clinicaltrials.gov/study/NCT05949099 |