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

• ClinicalTrials.gov Identifier: NCT03049189
• Recruitment Status: Recruiting
• First Posted: February 9, 2017
• Last Update Posted: December 10, 2020
• Sponsor: ITM Solucin GmbH
• Collaborators: ABX CRO; PSI CRO AG
• Information provided by (Responsible Party): ITM Solucin GmbH

Tracking Information

• First Submitted Date: January 13, 2017
• First Posted Date: February 9, 2017
• Last Update Posted Date: December 10, 2020
• Actual Study Start Date: February 2, 2017
• Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 7, 2017)

progression-free survival (PFS) [ Time Frame: 12 weeks +/- 14 days, up to 24 months ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 7, 2017)

overall survival (OS) [ Time Frame: every 3 months for a period of at least 24 months ]

OS as secondary outcome measure will be assessed per patient from date of randomization until the date of death, whichever came first

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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)
• Brief Summary: 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: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Neuroendocrine Tumors

Intervention

• Drug: 177Lu-edotreotide PRRT
  PRRT using 177Lu-edotreotide will be performed 3-monthly. A maximum of four cycles will be administered.
  Other Names:

  • 177Lu-DOTATOC
  • 177Lu-Edo
• Drug: Everolimus
  Everolimus will be adminstered as a standard dosis of 10 mg daily which may be reduced where required for acceptable tolerability.
  Other Name: Afinitor
• Other: Amino-Acid Solution
  The Amino-Acid Solution (AAS) to be used in this study will contain a mixture of 25 g lysine and 25 g arginine diluted in 2000 mL of electrolyte solution, infused over 4 - 6 h, starting 30 - 60 min before PRRT
  Other Name: Arginine-Lysine Solution

Study Arms

• Experimental: 177Lu-edotreotide PRRT

  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)

  Interventions:

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

  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)

  Intervention: Drug: Everolimus

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: February 7, 2017): 300
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 2024
• Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)

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.).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Nicolas Schneider, Dr; info@itm-solucin.de

Contact: Mona M Wahba, Dr

• Listed Location Countries: Australia, Austria, France, Germany, Italy, Netherlands, Poland, South Africa, Spain, Switzerland, United Kingdom, United States

Administrative Information

• NCT Number: NCT03049189
• Other Study ID Numbers: ITM-LET-01
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: ITM Solucin GmbH
• Study Sponsor: ITM Solucin GmbH

Collaborators

• ABX CRO
• PSI CRO AG

• Investigators: Not Provided
• PRS Account: ITM Solucin GmbH
• Verification Date: July 2020