A Study of a New Drug, Nirogacestat, for Treating Desmoid Tumors That Cannot be Removed by Surgery

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

October 7, 2020

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Desmoid FibromatosisRecurrent Desmoid FibromatosisUnresectable Desmoid Fibromatosis
Interventions
PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Echocardiography Test

Undergo ECHO

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Nirogacestat

Given PO

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

PROCEDURE

X-Ray Imaging

Undergo x-ray

Trial Locations (98)

1145

Starship Children's Hospital, Grafton

2145

The Children's Hospital at Westmead, Westmead

4101

Queensland Children's Hospital, South Brisbane

6009

Perth Children's Hospital, Perth

8011

Christchurch Hospital, Christchurch

10032

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York

10065

Memorial Sloan Kettering Cancer Center, New York

10467

Montefiore Medical Center - Moses Campus, The Bronx

12208

Albany Medical Center, Albany

13210

State University of New York Upstate Medical University, Syracuse

14263

Roswell Park Cancer Institute, Buffalo

15224

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

17033

Penn State Children's Hospital, Hershey

19104

Children's Hospital of Philadelphia, Philadelphia

19803

Alfred I duPont Hospital for Children, Wilmington

20007

MedStar Georgetown University Hospital, Washington D.C.

20010

Children's National Medical Center, Washington D.C.

21287

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore

23507

Children's Hospital of The King's Daughters, Norfolk

24014

Carilion Children's, Roanoke

28203

Carolinas Medical Center/Levine Cancer Institute, Charlotte

29425

Medical University of South Carolina, Charleston

29605

BI-LO Charities Children's Cancer Center, Greenville

30329

Children's Healthcare of Atlanta - Arthur M Blank Hospital, Atlanta

32207

Nemours Children's Clinic-Jacksonville, Jacksonville

32610

University of Florida Health Science Center - Gainesville, Gainesville

32803

AdventHealth Orlando, Orlando

32827

Nemours Children's Hospital, Orlando

33607

Saint Joseph's Hospital/Children's Hospital-Tampa, Tampa

33701

Johns Hopkins All Children's Hospital, St. Petersburg

35233

Children's Hospital of Alabama, Birmingham

36604

USA Health Strada Patient Care Center, Mobile

37203

The Children's Hospital at TriStar Centennial, Nashville

37232

Vanderbilt University/Ingram Cancer Center, Nashville

37916

East Tennessee Childrens Hospital, Knoxville

38105

Saint Jude Children's Research Hospital, Memphis

39216

University of Mississippi Medical Center, Jackson

40202

Norton Children's Hospital, Louisville

43205

Nationwide Children's Hospital, Columbus

44195

Cleveland Clinic Foundation, Cleveland

44308

Children's Hospital Medical Center of Akron, Akron

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

45404

Dayton Children's Hospital, Dayton

46202

Riley Hospital for Children, Indianapolis

48109

C S Mott Children's Hospital, Ann Arbor

48823

Michigan State University, East Lansing

49007

Bronson Methodist Hospital, Kalamazoo

49503

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital, Grand Rapids

53226

Children's Hospital of Wisconsin, Milwaukee

53792

University of Wisconsin Carbone Cancer Center - University Hospital, Madison

60611

Lurie Children's Hospital-Chicago, Chicago

60637

University of Chicago Comprehensive Cancer Center, Chicago

61637

Saint Jude Midwest Affiliate, Peoria

63110

Washington University School of Medicine, St Louis

63141

Mercy Hospital Saint Louis, St Louis

64108

Children's Mercy Hospitals and Clinics, Kansas City

70118

Children's Hospital New Orleans, New Orleans

70121

Ochsner Medical Center Jefferson, New Orleans

73104

University of Oklahoma Health Sciences Center, Oklahoma City

75390

UT Southwestern/Simmons Cancer Center-Dallas, Dallas

76104

Cook Children's Medical Center, Fort Worth

77030

M D Anderson Cancer Center, Houston

78229

University of Texas Health Science Center at San Antonio, San Antonio

78723

Dell Children's Medical Center of Central Texas, Austin

79905

El Paso Children's Hospital, El Paso

80045

Children's Hospital Colorado, Aurora

80218

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center, Denver

83712

Saint Luke's Cancer Institute - Boise, Boise

84113

Primary Children's Hospital, Salt Lake City

85202

Banner Children's at Desert, Mesa

89102

University Medical Center of Southern Nevada, Las Vegas

89109

Sunrise Hospital and Medical Center, Las Vegas

89135

Alliance for Childhood Diseases/Cure 4 the Kids Foundation, Las Vegas

89144

Summerlin Hospital Medical Center, Las Vegas

89502

Renown Regional Medical Center, Reno

90027

Children's Hospital Los Angeles, Los Angeles

90095

Mattel Children's Hospital UCLA, Los Angeles

90242

Kaiser Permanente Downey Medical Center, Downey

92123

Rady Children's Hospital - San Diego, San Diego

92354

Loma Linda University Medical Center, Loma Linda

94158

UCSF Medical Center-Mission Bay, San Francisco

94304

Lucile Packard Children's Hospital Stanford University, Palo Alto

94609

UCSF Benioff Children's Hospital Oakland, Oakland

94611

Kaiser Permanente-Oakland, Oakland

95817

University of California Davis Comprehensive Cancer Center, Sacramento

96826

Kapiolani Medical Center for Women and Children, Honolulu

97239

Oregon Health and Science University, Portland

72202-3591

Arkansas Children's Hospital, Little Rock

06106

Connecticut Children's Medical Center, Hartford

20889-5600

Walter Reed National Military Medical Center, Bethesda

02114

Massachusetts General Hospital Cancer Center, Boston

02215

Dana-Farber Cancer Institute, Boston

07601

Hackensack University Medical Center, Hackensack

02903

Rhode Island Hospital, Providence

T3B 6A8

Alberta Children's Hospital, Calgary

T6G 2B7

University of Alberta Hospital, Edmonton

H3H 1P3

The Montreal Children's Hospital of the MUHC, Montreal

00926

University Pediatric Hospital, San Juan

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

SpringWorks Therapeutics, Inc.

INDUSTRY

lead

Children's Oncology Group

NETWORK