Study of Cryoablation and Nirogacestat for Desmoid Tumor

Part of paid clinical trials in Palo Alto, California.

Sponsor
Nam Bui
Study ID
NCT05949099
Phase
PHASE2
Status
Recruiting
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Conditions

  • Desmoid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nirogacestat — DRUG
    Nirogacestat 150 mg by mouth twice-daily continuously for Cycles 1 through 3. Treatment with nirogacestat may continue via this study protocol for up to 24 months (26 cycles of treatment), unless there is progression of disease, intolerance, start of new anticancer therapy, or Subject Study Completion or Termination occurs.
  • Cryoablation — PROCEDURE
    Cryoablation procedure (single session) of one tumor mass between Cycles 3 and 4 of nirogacestat treatment

Study Details

The primary purpose of this protocol is Systemic therapy with oral study agent, nirogacestat, followed by a single cryoablation procedure.

Key Dates

Start date
Aug 15, 2023
Status verified
Sep 2025
Primary completion
Feb 1, 2028
Completion
Feb 1, 2028

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nirogacestat 150 mg
    Patients will receive 3-cycle lead-in with systemic therapy with nirogacestat 150 mg po BID, given continuously.

Primary Outcome Measure

Clinical Benefit per RECIST v1.1 [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94395
Priyanka Reddy
[email protected]
650-497-8288
Amir Emami
[email protected]
(650) 723-2868
Nam Bui, M.D. (PRINCIPAL_INVESTIGATOR)
Pejman Ghanouni, M.D. (SUB_INVESTIGATOR)
Kristen Ganjoo, M.D. (SUB_INVESTIGATOR)
Maggie Zhou, M.D (SUB_INVESTIGATOR)

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By research site
Stanford University· Palo Alto, CA