Study to evaluate safety and dosimetry of Lutathera in adolescent patients with GEP-NETs and PPGLs.

Phase 1

• Conditions: somatostatin receptor positive gastroenteropancreatic neuroendocrine (GEP-NET) tumors, pheochromocytoma and paragangliomas; MedDRA version: 21.0Level: PTClassification code: 10052399Term: Neuroendocrine tumour Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code: 10077560Term: Gastroenteropancreatic neuroendocrine tumor disease Class: 10029104; MedDRA version: 20.0Level: PTClassification code: 10077559Term: Gastroenteropancreatic neuroendocrine tumour disease Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code: 10073860Term: Paraganglioma Class: 10029104; MedDRA version: 20.1Level: LLTClassification code: 10034876Term: Pheochromocytoma Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-507444-37-00
• Lead Sponsor: Advanced Accelerator Applications

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-05
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

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., Patients from 12 to < 18 years of age at the time of enrollment., 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., Performance status as determined by Karnofsky score = 50 or Lansky Play-Performance Scale score = 50., Parent’s ability to understand and the willingness to sign a written informed consent document for adolescents as determined by local regulations. Adolescents will sign assent along with parental/legal guardian consent or will co-sign consent with parent/legal guardian in accordance with local regulation, prior to participation in the study.

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., Patients with any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with the completion of the study., Patient with known incompatibility to CT scans with I.V. contrast due to allergic reaction or renal insufficiency. If such a patient can be imaged with MRI, then the patient would not be excluded., Patients who received any investigational agent within the last 30 days., Prior therapies and procedures as detailed in Section 5.2., Established or suspected pregnancy, Breastfeeding female patients unless they accept to discontinue breastfeeding from the 1st dose until 3 months after the last administration of study drug., Female patients of child-bearing potential (female pediatric patients who are menarchal or who become menarchal during the study), unless they are using highly effective methods of contraception during treatment and for 7 months after the last dose of Lutathera (see details in the Appendix 1). If local regulations deviate from the listed contraception methods to prevent pregnancy, local regulations apply and will be described in the ICF., Sexually active male patients, unless they agree to remain abstinent (refrain from heterosexual intercourse) or be willing to use condoms and highly effective methods of contraception with female partners of childbearing potential, and to use condoms with pregnant female partners during the treatment period and for at least 4 months after the last dose of Lutathera (see details in Appendix 1). In addition, male patients must refrain from donating sperm during this same period., Patients for whom in the opinion of the investigator other therapeutic options are considered more appropriate than the therapy offered in the study, based on patient and disease characteristics., Current spontaneous urinary incontinence., Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and proven no evidence of recurrence for 5 years., Hypersensitivity to the study drug active substance or to any of the excipients.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified