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NETTER-P - A Multicenter Open-label Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine (GEP-NET) Tumors, Pheochromocytoma and Paragangliomas (PPGL)

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NETTER-P - A Multicenter Open-label Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine (GEP-NET) Tumors, Pheochromocytoma and Paragangliomas (PPGL)

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DiagnosisGastroenteropancreatic Neuroendocrine Tumors, Pheochromocytoma, ParagangliomaStudy StatusOpen
PhaseII
Age12 to 17 Years OldRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: Lutetium [177Lu] oxodotreotide/dotatate (Other Name: Lutathera) Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial)
Last Posted Update2022-12-22
ClinicalTrials.gov #NCT04711135
International Sponsor
Advanced Accelerator Applications
Principal Investigators for Canadian Sites
CHU de Québec – Université Laval – Dr François-Alexandre Buteau
Centres
Medical contact
Raoul Santiago
 
Social worker/patient navigator contact
Isabelle Audet
 
Clinical research contact
Barbara Desbiens
 

 

 

 

Study Description

This is a phase 2 study designed to evaluate the safety of a drug called Lutathera in patients 12 to <18 years old with GEP-NET and PPGL disease. For patients on the study, this drug will be infused 4 times at 8-week intervals. After the infusions are complete, a follow-up period will take place after the last dose for each patient who received at least one dose of Lutathera.

Inclusion Criteria
  • Patients must have a diagnosis of GEP-NET or PPGL that has gotten worse or can not be operated on
  • Patients must be between 12 to <18 years old at the time of enrollment
  • Patients must be up and about for over half of their waking hours
  • Patients and their families (as applicable) must agree to sign the written informed consent forms outlined by the study team

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team.