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History of Changes for Study: NCT03049189
Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients (COMPETE)
Latest version (submitted June 7, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 7, 2017 None (earliest Version on record)
2 March 9, 2017 Study Status and Contacts/Locations
3 August 17, 2017 Oversight, Study Status and Arms and Interventions
4 October 12, 2017 Study Status and Contacts/Locations
5 January 22, 2018 Contacts/Locations, Study Status, Eligibility and Arms and Interventions
6 July 20, 2018 Study Status, Contacts/Locations and Eligibility
7 September 14, 2018 Study Status and Contacts/Locations
8 July 9, 2019 Contacts/Locations and Study Status
9 September 18, 2019 Study Status, Contacts/Locations and Oversight
10 November 27, 2019 Contacts/Locations and Study Status
11 December 13, 2019 Study Status and Contacts/Locations
12 February 12, 2020 Contacts/Locations and Study Status
13 June 3, 2020 Contacts/Locations and Study Status
14 July 20, 2020 Contacts/Locations, Study Status and Sponsor/Collaborators
15 July 22, 2020 Study Status
16 August 7, 2020 Contacts/Locations and Study Status
17 December 9, 2020 Contacts/Locations and Study Status
18 February 1, 2021 Contacts/Locations and Study Status
19 March 11, 2021 Study Status, Contacts/Locations and Eligibility
20 March 11, 2021 Outcome Measures and Study Status
21 April 12, 2021 Contacts/Locations, Study Status and Eligibility
22 September 8, 2021 Contacts/Locations and Study Status
23 September 10, 2021 Contacts/Locations and Study Status
24 September 15, 2021 Contacts/Locations and Study Status
25 December 14, 2021 Contacts/Locations and Study Status
26 April 11, 2022 Recruitment Status, Study Status, Contacts/Locations and Study Design
27 June 7, 2022 Study Status and Study Design
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Study NCT03049189
Submitted Date:  February 7, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: ITM-LET-01
Brief Title: Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients (COMPETE)
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)
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2017
Overall Status: Recruiting
Study Start: February 2, 2017
Primary Completion: December 2020 [Anticipated]
Study Completion: May 2021 [Anticipated]
First Submitted: January 13, 2017
First Submitted that
Met QC Criteria:
February 7, 2017
First Posted: February 9, 2017 [Estimate]
Last Update Submitted that
Met QC Criteria:
February 7, 2017
Last Update Posted: February 9, 2017 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: ITM Solucin GmbH
Responsible Party: Sponsor
Collaborators: ABX CRO
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Neuroendocrine Tumors
Keywords: non-functional and functional P-NET
non-functional GE-NET
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 300 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: 177Lu-edotreotide PRRT

177Lu-edotreotide (177Lu-DOTATOC)

A maximum of four cycles of 7.5 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
Other Names:
  • 177Lu-DOTATOC
  • 177Lu-Edo
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 Names:
  • 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
Other Names:
  • Afinitor
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
  • Prior exposure to any peptide receptor radionuclide therapy (PRRT)
  • Prior therapy with mTor inhibitors
  • Prior EFR (extended 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.
Open or close this module Contacts/Locations
Central Contact Person: Konstantin Zhernosekov, Dr
Email: info@itm-solucin.de
Central Contact Backup: Ulrike Schorr-Neufing, Dr
Email: info@abx-cro.com
Locations: Australia, New South Wales
Royal North Shore Hospital
[Not yet recruiting]
Saint Leonards, New South Wales, Australia, 2065
Australia, Victoria
Olivia Newton-John Cancer & Wellness Centre, Austin Hospital
[Not yet recruiting]
Heidelberg, Victoria, Australia, 3084
Peter MacCallum Cancer Centre
[Recruiting]
Melbourne, Victoria, Australia, 3000
Austria
Allgemeines Krankenhaus Wien
[Not yet recruiting]
Wien, Austria, 1090
France
Hospices civils de Lyon
[Not yet recruiting]
Bron, France, 69677
HP Hôpital Beaujon
[Not yet recruiting]
Clichy, France, 92110
Institut de Recherche en Cancérologie de Montpellier (IRCM)
[Not yet recruiting]
Montpellier, France, 34298
CHU de Nantes - Hôtel Dieu
[Not yet recruiting]
Nantes, France, 44093
Germany
Zentralklinik Bad Berka GmbH
[Not yet recruiting]
Bad Berka, Germany, 99437
Charité - Universitätsmedizin Berlin
[Not yet recruiting]
Berlin, Germany, 10117
Universitätsklinikum Bonn
[Not yet recruiting]
Bonn, Germany, 53127
Universitätsklinikum des Saarlandes
[Not yet recruiting]
Homburg, Germany, 66421
Philipps Universität Marburg
[Not yet recruiting]
Marburg, Germany, 35043
LMU - Klinikum der Universität München, Campus Großhadern
[Not yet recruiting]
Munich, Germany, 81377
Universitätsklinikum Würzburg
[Not yet recruiting]
Wurzburg, Germany, 97080
Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) Srl
[Not yet recruiting]
Meldola, Italy, 47014
European Institute of Oncology (EIO)
[Not yet recruiting]
Milano, Italy, 20141
Netherlands
Academic Medical Center, University of Amsterdam
[Not yet recruiting]
Amsterdam, Netherlands, 1100DD
Poland
MSC Memorial Cancer Centre
[Not yet recruiting]
Gliwice, Poland, 44-100
Jagiellonian University
[Not yet recruiting]
Krakow, Poland, 31-501
Medical University of Warsaw
[Not yet recruiting]
Warsaw, Poland, 02-097
South Africa
University of Pretoria & Steve Biko Academic Hospital
[Not yet recruiting]
Pretoria, South Africa, 0001
Switzerland
Universitätsspital Basel
[Not yet recruiting]
Basel, Switzerland, 4031
Inselspital, Universitätsspital Bern
[Not yet 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
[Not yet recruiting]
London, United Kingdom, NW3 2QG
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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