We are experiencing 4 week turn-around time in review of submissions and resubmissions. We recommend commencing this process concurrently with your ethics submission and allowing at least 8 weeks for registration to be completed from date of first submission. We currently do not have the capacity to expedite reviews.

Note also there are delays to review of updates. We appreciate your patience.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03049189




Registration number
NCT03049189
Ethics application status
Date submitted
13/01/2017
Date registered
9/02/2017
Date last updated
13/04/2021

Titles & IDs
Public title
Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients
Scientific 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 ID [1] 0 0
ITM-LET-01
Universal Trial Number (UTN)
Trial acronym
COMPETE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuroendocrine Tumors 0 0
Condition category
Condition code
Cancer 0 0 0 0
Neuroendocrine tumour (NET)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 177Lu-edotreotide PRRT
Treatment: Drugs - Everolimus
Other interventions - Amino-Acid Solution

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)

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)


Treatment: Drugs: 177Lu-edotreotide PRRT
PRRT using 177Lu-edotreotide will be performed 3-monthly. A maximum of four cycles will be administered.

Treatment: Drugs: Everolimus
Everolimus will be adminstered as a standard dosis of 10 mg daily which may be reduced where required for acceptable tolerability.

Other interventions: 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

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
12 weeks +/- 14 days, up to 30 months
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
every 3 months for a period of at least 30 months

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
St George Hospital - Kogarah
Recruitment hospital [2] 0 0
Royal North Shore Hospital - Saint Leonards
Recruitment hospital [3] 0 0
Olivia Newton-John Cancer & Wellness Centre, Austin Hospital - Heidelberg
Recruitment hospital [4] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [5] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
3000 - Melbourne
Recruitment postcode(s) [5] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Iowa
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Washington
Country [11] 0 0
Austria
State/province [11] 0 0
Wien
Country [12] 0 0
Belgium
State/province [12] 0 0
Brussels
Country [13] 0 0
Belgium
State/province [13] 0 0
Leuven
Country [14] 0 0
Czechia
State/province [14] 0 0
Olomouc
Country [15] 0 0
Czechia
State/province [15] 0 0
Ostrava
Country [16] 0 0
Czechia
State/province [16] 0 0
Prague
Country [17] 0 0
France
State/province [17] 0 0
Bron
Country [18] 0 0
France
State/province [18] 0 0
Clermont-Ferrand
Country [19] 0 0
France
State/province [19] 0 0
Clichy
Country [20] 0 0
France
State/province [20] 0 0
Montpellier
Country [21] 0 0
France
State/province [21] 0 0
Nantes
Country [22] 0 0
France
State/province [22] 0 0
Toulouse
Country [23] 0 0
Germany
State/province [23] 0 0
Bad Berka
Country [24] 0 0
Germany
State/province [24] 0 0
Berlin
Country [25] 0 0
Germany
State/province [25] 0 0
Bonn
Country [26] 0 0
Germany
State/province [26] 0 0
Erlangen
Country [27] 0 0
Germany
State/province [27] 0 0
Essen
Country [28] 0 0
Germany
State/province [28] 0 0
Hamburg
Country [29] 0 0
Germany
State/province [29] 0 0
Homburg
Country [30] 0 0
Germany
State/province [30] 0 0
Magdeburg
Country [31] 0 0
Germany
State/province [31] 0 0
Marburg
Country [32] 0 0
Germany
State/province [32] 0 0
Munich
Country [33] 0 0
Germany
State/province [33] 0 0
Ulm
Country [34] 0 0
Germany
State/province [34] 0 0
Wurzburg
Country [35] 0 0
Italy
State/province [35] 0 0
Meldola
Country [36] 0 0
Italy
State/province [36] 0 0
Milano
Country [37] 0 0
Netherlands
State/province [37] 0 0
Amsterdam
Country [38] 0 0
Poland
State/province [38] 0 0
Gliwice
Country [39] 0 0
Poland
State/province [39] 0 0
Krakow
Country [40] 0 0
Poland
State/province [40] 0 0
Warsaw
Country [41] 0 0
South Africa
State/province [41] 0 0
Cape Town
Country [42] 0 0
South Africa
State/province [42] 0 0
Pretoria
Country [43] 0 0
Spain
State/province [43] 0 0
Barcelona
Country [44] 0 0
Spain
State/province [44] 0 0
Madrid
Country [45] 0 0
Spain
State/province [45] 0 0
Oviedo
Country [46] 0 0
Spain
State/province [46] 0 0
Valencia
Country [47] 0 0
Switzerland
State/province [47] 0 0
Basel
Country [48] 0 0
Switzerland
State/province [48] 0 0
Bern
Country [49] 0 0
Switzerland
State/province [49] 0 0
Saint Gallen
Country [50] 0 0
Switzerland
State/province [50] 0 0
Zürich
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Glasgow
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Liverpool
Country [53] 0 0
United Kingdom
State/province [53] 0 0
London
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ITM Solucin GmbH
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
ABX CRO
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
PSI CRO
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/show/NCT03049189
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Nicolas Schneider, Dr
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
info@itm-solucin.de
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03049189