Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With GEP-NETs and PPGLs

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)

ClinicalTrials.gov Identifier: NCT04711135

Novartis Reference Number: CAAA601A32201

Last Update: May 11, 2022

See if you pre-qualify

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

This is a multicenter, open-label, single-arm study to evaluate the safety and dosimetry of Lutathera in adolescent patients 12 to <18 years old with somatostatin receptor positive GEP-NETs and PPGLs. The study will enroll at least 8 patients in the GEP-NET cohort and as many adolescents with PPGL as possible in the exploratory PPGL cohort.

Condition 
Gastroenteropancreatic Neuroendocrine Tumors
Pheochromocytoma
Paraganglioma
Phase 
Phase 2
Overall status 
Recruiting
Start date 
May 31, 2022
Completion date 
Jul 01, 2028
Gender 
All
Age(s)
12 Years - 17 Years (Child)

Interventions

Drug
Lutetium [177Lu] oxodotreotide/dotatate
Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial)

Eligibility Criteria

Key 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.

or 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.

Key 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.
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, unless they are using highly effective methods of contraception during treatment and for 6 months after the last dose of Lutathera.
Sexually active male patients, unless they agree to remain abstinent or be willing to use effective methods of contraception.
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.
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.

Study Locations

Belgium
University Hospitals Leuven (UZ Leuven)
Recruiting
Louvain,
-
Belgium
France
Centre Léon Berard
Recruiting
Lyon,
-
France
Italy
Bambin Gesu' Hospital
Recruiting
Roma,
-
Italy
Netherlands
Prinses Maxima (UMC Utrecht)
Recruiting
Utrecht,
-
Netherlands
Poland
Maria Sklodowska-Curie National Research Institute of Oncology
Recruiting
Gliwice,
-
Poland
Spain
Hospital Universitari Vall d'Hebron
Recruiting
Barcelona,
-
Spain
University Hospital 12 de Octubre
Recruiting
Madrid,
-
Spain

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]