Trial Search Results

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

This study aims to compare two different treatment options for GEPNET: everolimus a current routine treatment and a new treatment option called Peptide Receptor Radionuclide Therapy (shortly PRRT). The PRRT that is beingstudied is based on the administration of the radioactive pharmaceutical 177Luedotreotide.The goal of both treatment arms is to slow or stop tumor progression.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

ITM Solucin GmbH

Collaborator: ABX CRO

Stanford Investigator(s):

Intervention(s):

  • Drug: 177Lu-edotreotide PRRT
  • Drug: Everolimus
  • Other: Amino-Acid Solution

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Histologically 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

   - Progressive disease based on RECIST 1.1. criteria as evidenced by two morphological
   imaging examinations made with the same imaging method (either CT or MRI)

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 within 90 days before
   randomisation 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

   - Clinically relevant 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.).

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
David Marcellus
650-723-4547
Recruiting