Evaluation of the Response and Non-response of Nirogacestat in Desmoid Tumors- Clinical Study

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05879146
Phase
PHASE2
Status
Recruiting
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Conditions

  • Tumor

Eligibility Criteria

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

Interventions

  • Nirogacestat — DRUG
    Given by PO

Study Details

To learn about the safety and effects of an investigational drug called nirogacestat when given to participants with a desmoid tumor/aggressive fibromatosis

Key Dates

Start date
Nov 26, 2024
Status verified
May 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2028

Study Design

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

Arms

  • Experimental: nirogacestat
    Participants will take nirogacestat by mouth every day of each 28-day study cycle. Based on when you enroll in this study, you will take nirogacestat either 1 time a day at about the same time each day OR 2 times a day, about 12 hours apart.

Primary Outcome Measure

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 [ Time Frame: through study completion; an average of 1 year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Keila Torres, MD, PHD
[email protected]
713-792-4242
Keila Torres, MD, PHD (PRINCIPAL_INVESTIGATOR)

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