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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04919226




Registration number
NCT04919226
Ethics application status
Date submitted
1/06/2021
Date registered
9/06/2021
Date last updated
14/06/2024

Titles & IDs
Public title
Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE
Scientific title
A Prospective, Randomised, Controlled, Open-label, Multicentre Study to Evaluate Efficacy, Safety and Patient-Reported Outcomes of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide Compared to Best Standard of Care in Patients With Well-differentiated Aggressive Grade 2 and Grade 3, Somatostatin Receptor-Positive (SSTR+), Neuroendocrine Tumours of GastroEnteric or Pancreatic Origin
Secondary ID [1] 0 0
DP-1111-02CT
Universal Trial Number (UTN)
Trial acronym
COMPOSE
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 (Peptide Receptor Radionuclide Therapy) PRRT
Treatment: Drugs - CAPTEM (Capecitabine and Temozolomide)
Other interventions - Amino-Acid Solution
Treatment: Drugs - Everolimus
Treatment: Drugs - FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin)

Experimental: Peptide Receptor Radionuclide Therapy (PRRT) Arm -

Active comparator: CAPTEM(Capecitabine-Temozolomide), Everolimus, FOLFOX(Folinic acid + Fluorouracil + Oxaliplatin) -


Treatment: Drugs: 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT
Peptide Receptor Radionuclide Therapy (PRRT) using 177Lu-edotreotide with a defined number of cycles will be administered.

Treatment: Drugs: CAPTEM (Capecitabine and Temozolomide)
Best standard of care treatment (investigator's choice \[from the protocol comparator list\]) according to individual risk-benefit assessment, institutional protocols, the local Prescribing Information, local regulations, or the local guidelines.

Other interventions: Amino-Acid Solution
The Amino-Acid Solution (AAS) to be used in this study will contain a mixture of lysine and arginine diluted in an electrolyte solution.

Treatment: Drugs: Everolimus
Best standard of care treatment (investigator's choice \[from the protocol comparator list\]) according to individual risk-benefit assessment, institutional protocols, the local Prescribing Information, local regulations, or the local guidelines.

Treatment: Drugs: FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin)
Best standard of care treatment (investigator's choice \[from the protocol comparator list\]) according to individual risk-benefit assessment, institutional protocols, the local Prescribing Information, local regulations, or the local guidelines.
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
Timepoint [1] 0 0
Every 12 weeks from randomization until disease progression or death whichever occurs earlier, during the time necessary to observe 148 Progression Free Survival (PFS) events.
Secondary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
Up to 2 years after disease progression

Eligibility
Key inclusion criteria
* Patients aged = 18 years.
* Histologically confirmed diagnosis of unresectable, well-differentiated GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs). measurable site of disease per RECIST v1.1 (Response evaluation criteria in solid tumors) using contrast computed tomography (CT) / magnetic resonance imaging (MRI).
* Somatostatin receptor-positive (SSTR+) disease.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Known hypersensitivity to Lutetium 177Lu, edotreotide, DOTA (dodecane tetraacetic acid), any of the comparators, or any excipient or derivative (e.g. rapamycin).
* Prior (Peptide Receptor Radionuclide Therapy) PRRT.
* Any major surgery within 4 weeks prior to randomization in the trial.
* Therapy with an investigational compound and/or medical device within 30 days or 7 half-life periods (whichever is longer) prior to randomization.
* Other known malignancies.
* Serious non-malignant disease.
* Renal, hepatic, cardiovascular, or hematological organ dysfunction, potentially interfering with the safety of the trial treatments.
* Pregnant or breastfeeding women.
* Patients not able to declare meaningful informed consent on their own or any other vulnerable population to that.

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
21/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2027
Actual
Sample size
Target
202
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [2] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards
Recruitment postcode(s) [2] 0 0
VIC 3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
Colorado
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United States of America
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Florida
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United States of America
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Massachusetts
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United States of America
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Minnesota
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United States of America
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Missouri
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New York
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United States of America
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North Carolina
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United States of America
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Oregon
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United States of America
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Pennsylvania
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United States of America
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Texas
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United States of America
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Utah
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France
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Bordeaux
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France
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Cedex
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France
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Lyon
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France
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Toulouse
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Germany
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Berlin
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Germany
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Bonn
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Germany
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Erlangen
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Germany
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Essen
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India
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Delhi
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India
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Karnataka
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India
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Mumbai
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Italy
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Messina
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Italy
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Milan
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Italy
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Naples
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Italy
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Rome
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Netherlands
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Amsterdam
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Netherlands
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Rotterdam
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Oviedo
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Spain
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Santiago De Compostela
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Spain
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Valencia
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Sweden
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Uppsala
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United Kingdom
State/province [36] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ITM Solucin GmbH
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study is to evaluate the efficacy, safety \& patient-reported outcomes of peptide receptor radionuclide therapy (PRRT) with 177Lu-Edotreotide as 1st or 2nd line of treatment compared to best standard of care in patients with well-differentiated aggressive grade 2 and grade 3, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin.
Trial website
https://clinicaltrials.gov/study/NCT04919226
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-solucin@itm-radiopharma.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04919226