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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05017662




Registration number
NCT05017662
Ethics application status
Date submitted
6/08/2021
Date registered
24/08/2021
Date last updated
3/06/2024

Titles & IDs
Public title
A Long-term Safety Surveillance Study in Participants Previously Treated With 177Lu-IPN01072
Scientific title
A Multicentre Surveillance Study to Evaluate the Long-term Safety in Participants Who Have Been Previously Treated With 177Lu-IPN01072 in an Ipsen-sponsored Clinical Study
Secondary ID [1] 0 0
2020-003640-88
Secondary ID [2] 0 0
D-FR-01072-004
Universal Trial Number (UTN)
Trial acronym
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
Other interventions - Data collection

Other: Data collection -


Other interventions: Data collection
Participants will have surveillance visits every 3 months up to 5 years after their first dose of 177Lu-IPN01072 in Study OPS-C-001.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants with second primary haematological and non-haematological malignancies.
Timepoint [1] 0 0
During the whole study period (approximately 5 years).
Secondary outcome [1] 0 0
Proportion of treatment-related adverse events of any grade.
Timepoint [1] 0 0
During the whole study period (approximately 5 years).
Secondary outcome [2] 0 0
Changes over time in laboratory tests (haematology)
Timepoint [2] 0 0
During the whole study period (approximately 5 years).
Secondary outcome [3] 0 0
Changes over time in laboratory tests (biochemistry)
Timepoint [3] 0 0
During the whole study period (approximately 5 years).
Secondary outcome [4] 0 0
Overall survival defined as the time from the first dose of 177Lu-IPN01072 until death from any cause.
Timepoint [4] 0 0
During the whole study period (approximately 5 years).

Eligibility
Key inclusion criteria
- Participant is capable of giving signed informed consent

- Participant must have received at least one infusion of 177Lu-IPN01072 in Study
OPS-C-001
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- There are no exclusion criteria in this safety surveillance study.

Study design
Purpose of the study
Other
Allocation to intervention
N/A
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2025
Actual
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Peter Maccallum Cancer Center - Melbourne
Recruitment hospital [2] 0 0
Ramsay Hollywood Private Hospital - Perth
Recruitment postcode(s) [1] 0 0
3002 - Melbourne
Recruitment postcode(s) [2] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
Denmark
State/province [2] 0 0
Aarhus
Country [3] 0 0
France
State/province [3] 0 0
Nantes
Country [4] 0 0
Switzerland
State/province [4] 0 0
Basel
Country [5] 0 0
United Kingdom
State/province [5] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Ipsen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the protocol is to evaluate the long-term safety of medicine 177Lu-satoreotide
tetraxetan (also known as 177Lu-IPN01072 or 177Lu-OPS201) for patients who have previously
received 177Lu-satoreotide tetraxetan in the clinical study OPS-C-001 / D-FR-01072-001.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05017662
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ipsen Medical Director
Address 0 0
Ipsen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05017662