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Long-term Safety of 177Lu-IPN01072 for Neuroendocrine Cancer
N/A
Waitlist Available
Research Sponsored by Ipsen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant must have received at least one infusion of 177Lu-IPN01072 in Study OPS-C-001
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the whole study period (approximately 5 years).
Awards & highlights
No Placebo-Only Group
Summary
This trial is to study the long-term safety of a medicine for patients who have received it in a previous study.
Who is the study for?
This study is open to individuals who have previously received at least one infusion of the drug 177Lu-satoreotide tetraxetan (also known as 177Lu-IPN01072) in a specific clinical trial. Participants must be able to give informed consent. There are no exclusion criteria for this safety surveillance.
What is being tested?
The study isn't testing a new treatment but is collecting long-term safety data on the medicine 177Lu-satoreotide tetraxetan, which participants have already been treated with in an earlier phase of research.
What are the potential side effects?
Since this trial involves data collection rather than administering drugs, it does not introduce new side effects. However, it monitors any long-term side effects from previous treatments with 177Lu-satoreotide tetraxetan.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have received at least one dose of 177Lu-IPN01072 in a specific study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during the whole study period (approximately 5 years).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the whole study period (approximately 5 years).
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Changes over time in laboratory tests (biochemistry)
Changes over time in laboratory tests (haematology)
Proportion of treatment-related adverse events of any grade.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Data collectionExperimental Treatment1 Intervention
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Who is running the clinical trial?
IpsenLead Sponsor
351 Previous Clinical Trials
74,329 Total Patients Enrolled
34 Trials studying Neuroendocrine Tumors
2,974 Patients Enrolled for Neuroendocrine Tumors
Ipsen Medical DirectorStudy DirectorIpsen
260 Previous Clinical Trials
56,223 Total Patients Enrolled
26 Trials studying Neuroendocrine Tumors
2,265 Patients Enrolled for Neuroendocrine Tumors
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am able to understand and sign the consent form.I have received at least one dose of 177Lu-IPN01072 in a specific study.
Research Study Groups:
This trial has the following groups:- Group 1: Data collection
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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