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

Primary Purpose

Neuroendocrine Tumors

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
177Lu-edotreotide PRRT
Everolimus
Amino-Acid Solution
Sponsored by
ITM Solucin GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuroendocrine Tumors focused on measuring non-functional and functional P-NET, non-functional GE-NET

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.).

Sites / Locations

  • Banner Health d.b.a. Banner MD Anderson Cancer Center
  • Stanford University
  • Moffitt Cancer Center & Research Institute
  • Northwestern Memorial Hospital
  • University of Michigan Comprehensive Cancer Center
  • Excel Diagnostics & Nuclear Oncology Center
  • Royal North Shore Hospital
  • Olivia Newton-John Cancer & Wellness Centre, Austin Hospital
  • Peter MacCallum Cancer Centre
  • Fiona Stanley Hospital
  • Allgemeines Krankenhaus Wien
  • Institut Jules Bordet
  • Universitaire Ziekenhuizen Leuven
  • University Hospital Olomouc
  • University Hospital Motol
  • Hospices civils de Lyon
  • Centre Jean Perrin
  • HP Hôpital Beaujon
  • Institut de Recherche en Cancérologie de Montpellier (IRCM)
  • CHU de Nantes - Hôtel Dieu
  • IUCT-Oncopole
  • Zentralklinik Bad Berka GmbH
  • Charité - Universitätsmedizin Berlin
  • Universitätsklinikum Bonn
  • Universitätsklinikum Erlangen
  • Universitätsklinikum Essen
  • University Medical Center, Abteilung für Nuklearmedizin
  • Universitätsklinikum Magdeburg A.ö.R., Otto-von-Guericke Universität
  • Philipps Universität Marburg
  • Klinikum rechts der Isar Technische Universität München
  • Universitätsklinikum Ulm
  • Universitätsklinikum Würzburg
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) Srl
  • Azienda Ospedaliera Universitaria (AOU) Policlinico "Gaetano Martino"
  • Fondazione IRCCS Istituto Nazionale dei Tumori
  • European Institute of Oncology (EIO)
  • Academic Medical Center, University of Amsterdam
  • MSC Memorial Cancer Centre
  • "Gammed" Izabela Chuchrowksa
  • University Cape Town (UCT), Groote Schuur Hospital
  • University of Pretoria & Steve Biko Academic Hospital
  • Vall d'Hebron University Hospital
  • ICO Hospitalet, Granvia de l'Hospitalet
  • MD Anderson Cancer Center Madrid
  • University Hospital 12 de Octubre
  • Central University Hospital de Asturias (HUCA)
  • University and Polytechnic Hospital La Fe
  • Universitätsspital Basel
  • Inselspital, Universitätsspital Bern
  • UniversitätsSpital Zürich
  • Royal Free NHS Foundation Trust
  • Kings College Hospital
  • The Christie NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

177Lu-edotreotide PRRT

Everolimus

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

progression-free survival (PFS)
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

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

Full Information

First Posted
January 13, 2017
Last Updated
August 21, 2023
Sponsor
ITM Solucin GmbH
Collaborators
ABX CRO, PSI CRO
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1. Study Identification

Unique Protocol Identification Number
NCT03049189
Brief Title
Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2, 2017 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ITM Solucin GmbH
Collaborators
ABX CRO, PSI CRO

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumors
Keywords
non-functional and functional P-NET, non-functional GE-NET

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
309 (Actual)

8. Arms, Groups, and Interventions

Arm Title
177Lu-edotreotide PRRT
Arm Type
Experimental
Arm Description
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)
Arm Title
Everolimus
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
177Lu-edotreotide PRRT
Other Intervention Name(s)
177Lu-DOTATOC, 177Lu-Edo
Intervention Description
PRRT using 177Lu-edotreotide will be performed 3-monthly. A maximum of four cycles will be administered.
Intervention Type
Drug
Intervention Name(s)
Everolimus
Other Intervention Name(s)
Afinitor
Intervention Description
Everolimus will be adminstered as a standard dosis of 10 mg daily which may be reduced where required for acceptable tolerability.
Intervention Type
Other
Intervention Name(s)
Amino-Acid Solution
Other Intervention Name(s)
Arginine-Lysine Solution
Intervention Description
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
Primary Outcome Measure Information:
Title
progression-free survival (PFS)
Description
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
Time Frame
12 weeks +/- 14 days, up to 30 months
Secondary Outcome Measure Information:
Title
overall survival (OS)
Description
OS as secondary outcome measure will be assessed per patient from date of randomization until the date of death, whichever came first
Time Frame
every 3 months for a period of at least 30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.).
Facility Information:
Facility Name
Banner Health d.b.a. Banner MD Anderson Cancer Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Moffitt Cancer Center & Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Excel Diagnostics & Nuclear Oncology Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77042
Country
United States
Facility Name
Royal North Shore Hospital
City
Saint Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Olivia Newton-John Cancer & Wellness Centre, Austin Hospital
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Allgemeines Krankenhaus Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Universitaire Ziekenhuizen Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
University Hospital Olomouc
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
University Hospital Motol
City
Prague
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Hospices civils de Lyon
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
HP Hôpital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
Institut de Recherche en Cancérologie de Montpellier (IRCM)
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
CHU de Nantes - Hôtel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
IUCT-Oncopole
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Zentralklinik Bad Berka GmbH
City
Bad Berka
ZIP/Postal Code
99437
Country
Germany
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Universitätsklinikum Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
University Medical Center, Abteilung für Nuklearmedizin
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Facility Name
Universitätsklinikum Magdeburg A.ö.R., Otto-von-Guericke Universität
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Philipps Universität Marburg
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Klinikum rechts der Isar Technische Universität München
City
Munich
ZIP/Postal Code
81675
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Universitätsklinikum Würzburg
City
Wurzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) Srl
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria (AOU) Policlinico "Gaetano Martino"
City
Messina
ZIP/Postal Code
98125
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
European Institute of Oncology (EIO)
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Academic Medical Center, University of Amsterdam
City
Amsterdam
ZIP/Postal Code
1100DD
Country
Netherlands
Facility Name
MSC Memorial Cancer Centre
City
Gliwice
ZIP/Postal Code
44-100
Country
Poland
Facility Name
"Gammed" Izabela Chuchrowksa
City
Warsaw
ZIP/Postal Code
02-351
Country
Poland
Facility Name
University Cape Town (UCT), Groote Schuur Hospital
City
Cape Town
ZIP/Postal Code
7925
Country
South Africa
Facility Name
University of Pretoria & Steve Biko Academic Hospital
City
Pretoria
ZIP/Postal Code
0001
Country
South Africa
Facility Name
Vall d'Hebron University Hospital
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
ICO Hospitalet, Granvia de l'Hospitalet
City
Barcelona
ZIP/Postal Code
08909
Country
Spain
Facility Name
MD Anderson Cancer Center Madrid
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
University Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Central University Hospital de Asturias (HUCA)
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Facility Name
University and Polytechnic Hospital La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Universitätsspital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Inselspital, Universitätsspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
UniversitätsSpital Zürich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Royal Free NHS Foundation Trust
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Kings College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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