A Long-term Safety Surveillance Study in Participants Previously Treated With 177Lu-IPN01072
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.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
18 Years and Over
More Inclusion & Exclusion Criteria
- Participant is capable of giving signed informed consent.
- Participant must have received at least one infusion of 177Lu-IPN01072 in Study
- There are no exclusion criteria in this safety surveillance study.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
Ipsen Medical Director
Principal Investigator Affiliation
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
Australia, Austria, Canada, Denmark, France, Switzerland, United Kingdom
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
Arms & Interventions
Other: Data collection
Other: - 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.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Peter Maccallum Cancer Center, Melbourne, Australia