A Long-term Safety Surveillance Study in Participants Previously Treated With 177Lu-IPN01072

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

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.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Exclusion Criteria:

  • - There are no exclusion criteria in this safety surveillance study.

Trial Details

Trial ID:

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.

NCT05017662
Phase

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.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Ipsen
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ipsen Medical Director
Principal Investigator Affiliation Ipsen
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Austria, Canada, Denmark, France, Switzerland, United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Neuroendocrine Tumors
Additional Details

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

Arms

Other: Data collection

Interventions

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.

International Sites

Peter Maccallum Cancer Center, Melbourne, Australia

Status

Recruiting

Address

Peter Maccallum Cancer Center

Melbourne, , 3002

Ramsay Hollywood Private Hospital, Perth, Australia

Status

Active, not recruiting

Address

Ramsay Hollywood Private Hospital

Perth, , 6009

Medical University of Vienna, Vienna, Austria

Status

Recruiting

Address

Medical University of Vienna

Vienna, , 1090

CHU de Quebec - Université LAVAL, Québec, Canada

Status

Withdrawn

Address

CHU de Quebec - Université LAVAL

Québec, , G1R2J6

Aarhus University Hospital, Aarhus, Denmark

Status

Active, not recruiting

Address

Aarhus University Hospital

Aarhus, , 8200

Hôtel Dieu de Nantes, Nantes, France

Status

Active, not recruiting

Address

Hôtel Dieu de Nantes

Nantes, , 44093 Cedex 1

University Hospital Basel, Basel, Switzerland

Status

Recruiting

Address

University Hospital Basel

Basel, , 4031

Royal Free Hospital London, London, United Kingdom

Status

Active, not recruiting

Address

Royal Free Hospital London

London, , NW3 2QG

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