Neuroendocrine TumorsNCT05017662
A Long-term Safety Surveillance Study in Participants Previously Treated With 177Lu-IPN01072
A study testing Data collection in people with Neuroendocrine Tumors, run by Ariceum Therapeutics GmbH at 7 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- Data collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 7 sitesin 6 countries
- Study dates
- 14 Sep 2021to 29 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is capable of giving signed informed consent
- Participant must have received at least one infusion of 177Lu-IPN01072 in Study OPS-C-001
Who cannot join
- There are no exclusion criteria in this safety surveillance study.
Trial locations and contacts
7 sites in 6 countries.
7 sites in 6 countries
Australia2 sites
Peter Maccallum Cancer Center
Melbourne, 3002
Ramsay Hollywood Private Hospital
Perth, 6009
About this study
Official 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
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.
Read the detailed description
The study qualifies as interventional not because of the use of an investigational product, but because the imposed specific data collection includes assessments/blood collection and on-site visits not necessarily part of routine clinical practice.
- Conditions
- Neuroendocrine Tumors
- Being tested
- Data collection
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Participants will have surveillance visits every 3 months up to 5 years after their first dose of 177Lu-IPN01072 in Study OPS-C-001.
| Study group | Role | What they receive |
|---|---|---|
| Data collection | Other | Not described Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with second primary haematological and non-haematological malignancies.
Measured: During the whole study period (approximately 5 years).
Secondary outcomes (4)
Proportion of treatment-related adverse events of any grade.
Adverse events assessed according to the National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE Version 5.0), including any treatment-related serious adverse events, as assessed by the investigators.
Measured: During the whole study period (approximately 5 years).
Changes over time in laboratory tests (haematology)
Laboratory parameters (Platelet count, Haemoglobin and White Blood Cells count with differential) will be graded according to the NCI-CTCAE Version 5.0.
Measured: During the whole study period (approximately 5 years).
Changes over time in laboratory tests (biochemistry)
Laboratory parameters (Creatinine) will be graded according to the NCI-CTCAE Version 5.0.
Measured: During the whole study period (approximately 5 years).
Overall survival defined as the time from the first dose of 177Lu-IPN01072 until death from any cause.
Measured: During the whole study period (approximately 5 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start14 Sep 2021
- Primary completion29 Apr 2025
- Study completion29 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ariceum Therapeutics GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ariceum Chief Medical Officer, Study director, Ariceum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017662
- Sponsor's protocol ID
- D-FR-01072-004
- Other IDs
- 2024-515071-35-00
- Status last verified
- Jan 2025
- First submitted
- 6 Aug 2021
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05017662
- Acronym / sponsor ID
- D-FR-01072-004
- Conditions
- Neuroendocrine Tumors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ariceum Therapeutics GmbHIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 29 Apr 2025 (actual)
- Study completion
- 29 Apr 2025 (actual)
- First posted
- 24 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study qualifies as interventional not because of the use of an investigational product, but because the imposed specific data collection includes assessments/blood collection and on-site visits not necessarily part of routine clinical practice.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Data collection | Other | Other: Data collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participant is capable of giving signed informed consent
- Participant must have received at least one infusion of 177Lu-IPN01072 in Study OPS-C-001
Key exclusion criteria (1 listed)
- There are no exclusion criteria in this safety surveillance study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionParticipants will have surveillance visits every 3 months up to 5 years after their first dose of 177Lu-IPN01072 in Study OPS-C-001. | Other | Data collection |
Primary outcome
Proportion of participants with second primary haematological and non-haematological malignancies.
Time frame: During the whole study period (approximately 5 years).
4 secondary outcomes
Proportion of treatment-related adverse events of any grade.
Time frame: During the whole study period (approximately 5 years).
Changes over time in laboratory tests (haematology)
Time frame: During the whole study period (approximately 5 years).
Changes over time in laboratory tests (biochemistry)
Time frame: During the whole study period (approximately 5 years).
Overall survival defined as the time from the first dose of 177Lu-IPN01072 until death from any cause.
Time frame: During the whole study period (approximately 5 years).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ariceum Chief Medical Officer study director
Ariceum
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Data collection in people with Neuroendocrine Tumors, run by Ariceum Therapeutics GmbH at 7 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia, Austria, Denmark, France, Switzerland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with second primary haematological and non-haematological malignancies. (time frame: During the whole study period (approximately 5 years).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.