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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT05017662
Ethics application status
Date submitted
6/08/2021
Date registered
24/08/2021

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
Not applicable
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
When will data be available (start and end dates)?
Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
Available to whom?
Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/members/ourmembers/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05017662