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

Phase 2

Withdrawn

• Conditions: Gastroenteropancreatic neuroendocrine; GEP-NET; 10014713

• Registration Number: NL-OMON50857
• Lead Sponsor: Advanced Accelerator Applications

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 2

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 < 18 years of age at the time of enrollment.
3. Expression of somatostatin receptors confirmed by a somatostatin receptor
imaging (SRI) modality within 3 months prior to enrollment, with tumor uptake
observed in the target lesions more or equal to the normal liver uptake.
4. Performance status as determined by Karnofsky score >= 50 or Lansky
Play-Performance Scale score >= 50.

Exclusion Criteria

Laboratory parameters:
• Estimated creatinine clearance calculated by the Cockroft-Gault method < 70
mL/min
• Hb concentration <5.0 mmol/L (<8.0 g/dL); WBC <2x109/L; platelets <75x109/L.
• Total bilirubin >3 x ULN for age.
• Serum albumin <3.0 g/dL unless prothrombin time is within the normal range.

Study & Design

• Study Type: Interventional
• Study Design: Not specified