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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

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 - CAAA601A32201 (NETTER-P)

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50857
Enrollment
2
Registered
2021-06-14
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-09

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

Conditions

Gastroenteropancreatic neuroendocrine GEP-NET

Interventions

Lutathera (7.4 GBq/200 mCi x 4 administrations every 8 weeks
cumulative dose: 29.6 GBq/800 mCi), with a concomitant administration of 2.5% Lysine - Arginine amino acid (AA) solution

Sponsors

Advanced Accelerator Applications
Lead Sponsor

Eligibility

Age
12 Years to 17 Years

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 = 50 or Lansky Play-Performance Scale score >= 50.

Exclusion criteria

Exclusion criteria: Laboratory parameters: • Estimated creatinine clearance calculated by the Cockroft-Gault method 3 x ULN for age. • Serum albumin

Design outcomes

Primary

MeasureTime frame
- 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 GEPNETs—

Secondary

MeasureTime frame
- 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—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)