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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

Study 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.Check my eligibility

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.See study design

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 below

Select...

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).

This trial's timeline: 3 weeks for screening, Varies for treatment, and during the whole study period (approximately 5 years). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of participants with second primary haematological and non-haematological malignancies.

Secondary outcome measures

Changes over time in laboratory tests (biochemistry)

Changes over time in laboratory tests (haematology)

Overall survival defined as the time from the first dose of 177Lu-IPN01072 until death from any cause.

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Data collectionExperimental Treatment1 Intervention

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

IpsenLead Sponsor

345 Previous Clinical Trials

73,208 Total Patients Enrolled

34 Trials studying Neuroendocrine Tumors

2,984 Patients Enrolled for Neuroendocrine Tumors

Ipsen Medical DirectorStudy DirectorIpsen

257 Previous Clinical Trials

55,125 Total Patients Enrolled

26 Trials studying Neuroendocrine Tumors

2,275 Patients Enrolled for Neuroendocrine Tumors

Media Library

Data collection Clinical Trial Eligibility Overview. Trial Name: NCT05017662 — N/A

Neuroendocrine Tumors Research Study Groups: Data collection

Neuroendocrine Tumors Clinical Trial 2023: Data collection Highlights & Side Effects. Trial Name: NCT05017662 — N/A

Data collection 2023 Treatment Timeline for Medical Study. Trial Name: NCT05017662 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacancies to join this clinical investigation?

"Contrary to what is indicated on clinicaltrials.gov, this medical trial is currently not recruiting patients; the listing was first uploaded on September 14th 2021 and edited for the last time on October 20th 2022. Although this investigation has completed its recruitment phase, there are still 167 other studies actively searching for participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "A Long-term Safety Surveillance Study in Participants Previously Treated With 177Lu-IPN01072". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05017662.