Phase 2 study to evaluate safety and dosimetry of Lutathera in adolescent patients with GEP-NETs, pheochromocytoma and paragangliomas

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 - NETTER-P

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002951-39-FR

Enrollment

Registered

2020-12-03

Start date

2022-11-25

Completion date

Unknown

Last updated

2024-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

somatostatin receptor positive gastroenteropancreatic neuroendocrine (GEP-NET) tumors, pheochromocytoma and paragangliomas MedDRA version: 21.0 Level: PT Classification code 10052399 Term: Neuroendocrine tumour System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10077559 Term: Gastroenteropancreatic neuroendocrine tumour disease System Organ Class: 10029104 - Neoplasms benign, malignant and unspec

Interventions

Trade Name: Lutathera 370 MBq/mL solution for infusion Product Name: Lutathera 370 MBq/mL solution for infusion Pharmaceutical Form: Solution for infusion INN or Proposed INN: LUTETIUM (177LU) OXODOTR

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. GEP-NET cohort: Presence of metastasized or locally advanced, inoperable (curative intent), histologically proven, G1 or G2 (Ki-67 index =20%), well differentiated GEP-NET. PPGL cohort: presence of metastasized or locally advanced, inoperable (curative intent), histologically proven PPGL. 2. Patients from 12 to =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Laboratory parameters: • Estimated creatinine clearance calculated by the Cockroft-Gault method 3 x ULN for age. • Serum albumin <3.0 g/dL unless prothrombin time is within the normal range.

Design outcomes

Primary

Measure	Time frame
Main Objective: - To evaluate organ absorbed radiation doses from PRRT with Lutathera in adolescent patients with SSTR-positive GEP-NETs - To evaluate safety and tolerability of Lutathera in adolescents with SSTR-positive GEP-NETs ;Secondary Objective: - To evaluate cumulative safety of Lutathera in adolescents with SSTR-positive GEP-NETs - To evaluate long-term safety of Lutathera in adolescents with SSTR-positive GEP-NETs - To perform comparative assessment of dosimetry and pharmacokinetics (PK) between adolescent patients with GEP-NET and adult patients using the extrapolation model developed for the clinical study;Primary end point(s): - Target organ (e.g. kidney and bone marrow) absorbed radiation doses in adolescents with SSTR-positive GEP-NETs - The incidence of adverse events (AEs) and laboratory toxicities after the 1st Lutathera administration in adolescents with SSTR-positive GEP-NETs;Timepoint(s) of evaluation of this end point: After 1st administration	—

Measure

Time frame

Main Objective: - To evaluate organ absorbed radiation doses from PRRT with Lutathera in adolescent patients with SSTR-positive GEP-NETs - To evaluate safety and tolerability of Lutathera in adolescents with SSTR-positive GEP-NETs ;Secondary Objective: - To evaluate cumulative safety of Lutathera in adolescents with SSTR-positive GEP-NETs - To evaluate long-term safety of Lutathera in adolescents with SSTR-positive GEP-NETs - To perform comparative assessment of dosimetry and pharmacokinetics (PK) between adolescent patients with GEP-NET and adult patients using the extrapolation model developed for the clinical study;Primary end point(s): - Target organ (e.g. kidney and bone marrow) absorbed radiation doses in adolescents with SSTR-positive GEP-NETs - The incidence of adverse events (AEs) and laboratory toxicities after the 1st Lutathera administration in adolescents with SSTR-positive GEP-NETs;Timepoint(s) of evaluation of this end point: After 1st administration

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Secondary

Measure	Time frame
Secondary end point(s): - The incidence of adverse events (AEs) and laboratory toxicities until 6 months after the last Lutathera dose (short-term follow-up) in adolescents with SSTR-positive GEP-NETs - The incidence of adverse events (AEs) and laboratory abnormalities during the long term follow-up of 5 years after the last Lutathera dose in adolescents with SSTR-positive GEP-NETs - Calculated organ absorbed doses and PK parameters based on imaging/blood radioactivity concentration data from adolescent patients with SSTR-positive GEP-NETs compared to the predicted distribution / organ absorbed doses;Timepoint(s) of evaluation of this end point: After 1st administration, until 6 months after the last Lutathera dose and until 5 years after the last Lutathera dose	—

Measure

Time frame

Secondary end point(s): - The incidence of adverse events (AEs) and laboratory toxicities until 6 months after the last Lutathera dose (short-term follow-up) in adolescents with SSTR-positive GEP-NETs - The incidence of adverse events (AEs) and laboratory abnormalities during the long term follow-up of 5 years after the last Lutathera dose in adolescents with SSTR-positive GEP-NETs - Calculated organ absorbed doses and PK parameters based on imaging/blood radioactivity concentration data from adolescent patients with SSTR-positive GEP-NETs compared to the predicted distribution / organ absorbed doses;Timepoint(s) of evaluation of this end point: After 1st administration, until 6 months after the last Lutathera dose and until 5 years after the last Lutathera dose

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Countries

Belgium, Canada, France, Italy, Netherlands, Poland, Portugal, Spain, Sweden, United Kingdom, United States

Contacts

Public ContactMatthieu Ruffin

Advanced Accelerator Applications International SA

matthieu.ruffin@novartis.com+41225190700

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026