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

Ariceum Therapeutics GmbH

Status: Completed

Conditions: Neuroendocrine Tumors

Treatments: Other: Data collection

Study type: Interventional

Funder types: Industry

Identifiers

NCT05017662

2024-515071-35-00 (EU Trial (CTIS) Number)

D-FR-01072-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Data collection

Other group

Treatment:

Other: Data collection