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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. Identifier: NCT03049189
Recruitment Status : Recruiting
First Posted : February 9, 2017
Last Update Posted : September 17, 2018
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)
Estimated Enrollment : 300 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 : December 2020
Estimated Study Completion Date : May 2021

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 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

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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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 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.).

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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Contact: Konstantin Zhernosekov, Dr
Contact: Ulrike Schorr-Neufing, Dr

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Australia, New South Wales
Royal North Shore Hospital Recruiting
Saint Leonards, New South Wales, Australia, 2065
Australia, Victoria
Olivia Newton-John Cancer & Wellness Centre, Austin Hospital Recruiting
Heidelberg, Victoria, Australia, 3084
Peter MacCallum Cancer Centre Recruiting
Melbourne, Victoria, Australia, 3000
Allgemeines Krankenhaus Wien Recruiting
Wien, Austria, 1090
Hospices civils de Lyon Not yet recruiting
Bron, France, 69677
HP Hôpital Beaujon Recruiting
Clichy, France, 92110
Institut de Recherche en Cancérologie de Montpellier (IRCM) Recruiting
Montpellier, France, 34298
CHU de Nantes - Hôtel Dieu Recruiting
Nantes, France, 44093
Zentralklinik Bad Berka GmbH Recruiting
Bad Berka, Germany, 99437
Charité - Universitätsmedizin Berlin Recruiting
Berlin, Germany, 10117
Universitätsklinikum Bonn Recruiting
Bonn, Germany, 53127
Universitätsklinikum Erlangen Recruiting
Erlangen, Germany, 91054
Universitätsklinikum des Saarlandes Recruiting
Homburg, Germany, 66421
Philipps Universität Marburg Recruiting
Marburg, Germany, 35043
LMU - Klinikum der Universität München, Campus Großhadern Not yet recruiting
Munich, Germany, 81377
Universitätsklinikum Würzburg Recruiting
Wurzburg, Germany, 97080
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) Srl Recruiting
Meldola, Italy, 47014
European Institute of Oncology (EIO) Recruiting
Milano, Italy, 20141
Academic Medical Center, University of Amsterdam Recruiting
Amsterdam, Netherlands, 1100DD
MSC Memorial Cancer Centre Not yet recruiting
Gliwice, Poland, 44-100
Jagiellonian University Not yet recruiting
Krakow, Poland, 31-501
South Africa
University of Pretoria & Steve Biko Academic Hospital Recruiting
Pretoria, South Africa, 0001
Universitätsspital Basel Recruiting
Basel, Switzerland, 4031
Inselspital, Universitätsspital Bern Recruiting
Bern, Switzerland, 3010
United Kingdom
Clatterbridge Cancer Centre NHS Foundation Trust Not yet recruiting
Liverpool, United Kingdom, L7 8XP
Royal Free NHS Foundation Trust Recruiting
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
ITM Solucin GmbH

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Responsible Party: ITM Solucin GmbH Identifier: NCT03049189     History of Changes
Other Study ID Numbers: ITM-LET-01
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
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
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Antineoplastic Agents, Hormonal