Clinical Trials /

Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients

NCT03049189

Description:

The purpose of the study is to evaluate efficacy and safety of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Edotreotide compared to targeted molecular therapy with Everolimus in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin (GEP-NET).

Related Conditions:
  • Functional Pancreatic Neuroendocrine Tumor
  • Gastrointestinal Neuroendocrine Tumors
  • Non-functioning Pancreatic Endocrine Tumor
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients
  • Official Title: A Prospective, Randomised, Controlled, Open-label, Multicentre Phase III Study to Evaluate Efficacy and Safety of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide Compared to Targeted Molecular Therapy With Everolimus in Patients With Inoperable, Progressive, Somatostatin Receptor-positive (SSTR+), Neuroendocrine Tumours of Gastroenteric or Pancreatic Origin (GEP-NET)

Clinical Trial IDs

  • ORG STUDY ID: ITM-LET-01
  • NCT ID: NCT03049189

Conditions

  • Neuroendocrine Tumors

Interventions

DrugSynonymsArms
177Lu-edotreotide PRRT177Lu-DOTATOC, 177Lu-Edo177Lu-edotreotide PRRT
EverolimusAfinitorEverolimus

Purpose

The purpose of the study is to evaluate efficacy and safety of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Edotreotide compared to targeted molecular therapy with Everolimus in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin (GEP-NET).

Trial Arms

NameTypeDescriptionInterventions
177Lu-edotreotide PRRTExperimental177Lu-edotreotide (177Lu-DOTATOC) A maximum of four cycles of 7.5 ± 0.7 GBq (gigabequerel) 177Lu-edotreotide, each. Route of administration: Slow intravenous infusion/injection (i.v.) Duration of treatment: 4 cycles, 90 days apart (total duration: 270 days/9 months)
  • 177Lu-edotreotide PRRT
EverolimusActive ComparatorEverolimus (Afinitor ®) Doses: 10 mg/d Route of administration: Oral Duration of treatment: Continuous daily treatment until diagnosis of progression or End of Study (EOS)
  • Everolimus

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically and clinically confirmed diagnosis of well-differentiated
             neuro-endocrine tumour of non-functional gastroenteric origin (GE-NET) or both
             functional or non-functional pancreatic origin (P-NET)

          -  Measurable disease per RECIST 1.1

          -  Somatostatin receptor positive (SSTR+) disease

          -  Radiological disease progression, defined as progressive disease per RECIST 1.1.
             criteria

        Exclusion Criteria:

          -  Known hypersensitivity to edotreotide or everolimus

          -  Known hypersensitivity to DOTA, lutetium-177, or any excipient of edotreotide or
             everolimus or any other Rapamycin derivative

          -  Prior exposure to any peptide receptor radionuclide therapy (PRRT)

          -  Prior therapy with mTor inhibitors

          -  Prior EFR (external field radiation) to GEP-NET lesions or radioembolisation therapy

          -  Therapy with an investigational compound and/or medical device within 30 days prior to
             randomisation

          -  Indication for surgical lesion removal with curative potential

          -  Planned alternative therapy (for the period of study participation)

          -  Serious non-malignant disease

          -  Renal, hepatic, cardiovascular, or haematological organ dysfunction, potentially
             interfering with the safety of the study treatments

          -  Pregnant or breast-feeding women

          -  Subjects not able to declare meaningful informed consent on their own (e.g. with legal
             guardian for mental disorders) or any other vulnerable population to that sense (e.g.
             persons institutionalised, incarcerated etc.).
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:progression-free survival (PFS)
Time Frame:12 weeks +/- 14 days, up to 24 months
Safety Issue:
Description:PFS will be assessed individually per patient from date of randomization until the date of first documented progression, assessed up to 24 months, primary outcome will be measured by CT/MRI every 12 weeks +/- 14 days

Secondary Outcome Measures

Measure:overall survival (OS)
Time Frame:every 3 months for a period of at least 24 months
Safety Issue:
Description:OS as secondary outcome measure will be assessed per patient from date of randomization until the date of death, whichever came first

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:ITM Solucin GmbH

Trial Keywords

  • non-functional and functional P-NET
  • non-functional GE-NET

Last Updated