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).

Detailed Description

Trial Arms

NameTypeDescriptionInterventions
177Lu-edotreotide PRRTExperimental177Lu-edotreotide (177Lu-DOTATOC) A maximum of four cycles of 7.5 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

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

      - Prior therapy with mTor inhibitors

      - Prior EFR (extended 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.

      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

      February 7, 2017