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Clinical Trials/EUCTR2020-002951-39-PL
EUCTR2020-002951-39-PL
Active, not recruiting
Phase 1

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

Advanced Accelerator Applications SA0 sites12 target enrollmentJanuary 20, 2021
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DrugsLutathera 370 MBq/mL solution for infusion

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Advanced Accelerator Applications SA
Enrollment
12
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 20, 2021
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility 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 \< 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\.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 12
  • •F.1\.2 Adults (18\-64 years) no
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) no

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.

Outcomes

Primary Outcomes

Not specified

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