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).
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
Interventions
Drug | Synonyms | Arms |
---|
177Lu-edotreotide PRRT | 177Lu-DOTATOC, 177Lu-Edo | 177Lu-edotreotide PRRT |
Everolimus | Afinitor | Everolimus |
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
Name | Type | Description | Interventions |
---|
177Lu-edotreotide PRRT | Experimental | 177Lu-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) | |
Everolimus | Active Comparator | Everolimus (Afinitor ®)
Doses: 10 mg/d Route of administration: Oral Duration of treatment: Continuous daily treatment until diagnosis of progression or End of Study (EOS) | |
Eligibility Criteria
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.).
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 30 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 30 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 30 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
April 13, 2021