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

ConditionTumor
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years. Individuals younger than 18 years old are excluded. More than 99% of the population evaluated at MDACC with a diagnosis of DT is older than 18. Sixty-three percent of the population with a diagnosis of DT evaluated at MDACC are 10 - 54 years old. The remaining 37 percent are older than 54 years old. Additionally, most of the robust data related to dosing or adverse event data currently available on the use of nirogacestat is in adults

Histologically documented DT with evidence of radiographic tumor progression (≥ 10% or absolute increase in dimensions of ≥ 10 mm in maximal diameter) in unidimensional measurement within the previous 18 months. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam

Recurrent or primary disease

Symptomatic disease or impending morbidity (as defined by physician) and patient and physician agree treatment would be of benefit

Disqualifiers

Unable to undergo serial biopsies

Participants with familial adenomatous polyposis

Unable to tolerate MRI or for whom MRI is contraindicated

Pregnant or breastfeeding women are excluded from this study. Based on findings in animal studies, oral administration of nirogacestat to pregnant rats during the period of organogenesis resulted in embryo-fetal toxicities at maternal exposures that were significantly lower than adult human exposures at the recommended dose of 150 mg twice daily. Nirogacestat should be avoided during pregnancy

Trial design

Design model

Single group

Treatments tested in this trial

  • Nirogacestat

    Drug

    Given by PO

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: nirogacestatExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

SpringWorks Therapeutics, Inc.

Collaborator