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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03049189
Recruitment Status : Recruiting
First Posted : February 9, 2017
Last Update Posted : December 10, 2020
Sponsor:
Collaborators:
ABX CRO
PSI CRO AG
Information provided by (Responsible Party):
ITM Solucin GmbH

Tracking Information
First Submitted Date  ICMJE January 13, 2017
First Posted Date  ICMJE February 9, 2017
Last Update Posted Date December 10, 2020
Actual Study Start Date  ICMJE February 2, 2017
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neuroendocrine Tumors
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 7, 2017)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2024
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nicolas Schneider, Dr info@itm-solucin.de
Contact: Mona M Wahba, Dr
Listed Location Countries  ICMJE Australia,   Austria,   France,   Germany,   Italy,   Netherlands,   Poland,   South Africa,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03049189
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party ITM Solucin GmbH
Study Sponsor  ICMJE ITM Solucin GmbH
Collaborators  ICMJE
  • ABX CRO
  • PSI CRO AG
Investigators  ICMJE Not Provided
PRS Account ITM Solucin GmbH
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP