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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. Read our disclaimer for details. Identifier: NCT03049189
Recruitment Status : Active, not recruiting
First Posted : February 9, 2017
Last Update Posted : January 18, 2023
Information provided by (Responsible Party):
ITM Solucin GmbH

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).

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Drug: 177Lu-edotreotide PRRT Drug: Everolimus Other: Amino-Acid Solution Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 309 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : February 2, 2017
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2029

Arm Intervention/treatment
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)

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

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

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)

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

Primary Outcome Measures :
  1. progression-free survival (PFS) [ Time Frame: 12 weeks +/- 14 days, up to 30 months ]
    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 :
  1. overall survival (OS) [ Time Frame: every 3 months for a period of at least 30 months ]
    OS as secondary outcome measure will be assessed per patient from date of randomization until the date of death, whichever came first

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03049189

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Sponsors and Collaborators
ITM Solucin GmbH
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Responsible Party: ITM Solucin GmbH Identifier: NCT03049189    
Other Study ID Numbers: ITM-LET-01
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: January 18, 2023
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ITM Solucin GmbH:
non-functional and functional P-NET
non-functional GE-NET
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Pharmaceutical Solutions
Edotreotide lutetium LU-177
MTOR Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents