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Information is also accessible through the patient and families tab. Family friendly summaries are created and reviewed by our advocacy partners. The information is updated to the best of our knowledge but might not reflect the latest information. Note that most studies are only available at a limited number of sites, please click on ‘further information’ for details. Studies, particularly early phase trials, may also temporarily close to enrolment or not have slots available for all treatment groups. In all cases, study teams at individual C17 centres will have the most up-to-date information.

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Title
Status

 

ARST1921 - A Safety, Pharmacokinetic and Efficacy Study of a y-Secretase Inhibitor, Nirogacestat (PF-03084014) in Children and Adolescents With Progressive, Surgically Unresectable Desmoid Tumors

Closed to enrollment

More information

ARST1921 - A Safety, Pharmacokinetic and Efficacy Study of a y-Secretase Inhibitor, Nirogacestat (PF-03084014) in Children and Adolescents With Progressive, Surgically Unresectable Desmoid Tumors

Go to Health Care Provider version

DiagnosisUnresectable, Recurrent Desmoid FibromatosisStudy StatusClosed to enrollment
PhaseII
Age12 Months to 18 YearsRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: Nirogacestat (given orally)
Last Posted Update2024-03-19
ClinicalTrials.gov #NCT04195399
International Sponsor
Children's Oncology Group
Principal Investigators for Canadian Sites
Alberta Children's Hospital - Dr. Victor Lewis
Montreal Children's Hospital - Dr. Sharon B. Abish
CancerCare Manitoba - Dr. Ashley Chopek
Stollery Children's Hospital -
Centres
Medical contact
Dr. Victor Lewis

 

Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich
Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 
Medical contact
Dr. Magimairajan Vanan
Social worker/patient navigator contact
Rhéanne Bisson
 
Clinical research contact
Rebekah Hiebert
Megan Ridler
Kathy Hjalmarsson

 

 

Medical contact
Dr. Sarah McKillop
Dr. Sunil Desai

 

 

Social worker/patient navigator contact
Danielle Sikora
 Michelle Woytiuk 
Jaime Hobbs
Clinical research contact
Amanda Perreault

 

 

Study Description

This phase II trial studies how well the drug nirogacestat works in treating patients between the age of 1 to 18 years old with desmoid tumours that have grown after prior treatment and that cannot be removed by surgery. Nirogacestat works by blocking some of the chemicals that play a role in the growth of tumor cells. 

Inclusion Criteria
  • Patient must have a desmoid tumor that is existing or that has come back (recurrent) and that cannot be removed by surgery
  • Patients must be between 12 months to 18 years old 
  • At minimum, patients must be up and about at least 50% of their waking hours 
  • Blood work must come back within the acceptable ranges
  • Patients must have adequate heart function 
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • Your study doctor will discuss with you the medications you can and cannot take

Other inclusion and exclusion criteria may apply