A long-term safety surveillance study in participants previously treated with 177Lu-IPN01072
- Conditions
- euroendocrine tumors (NETs)MedDRA version: 21.0Level: PTClassification code 10052399Term: Neuroendocrine tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
- Registration Number
- EUCTR2020-003640-88-AT
- Lead Sponsor
- Ariceum Therapeutics GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 38
Participants are eligible to be included in the study only if all of the following criteria apply:
(1) Participant is capable of giving signed informed consent as described in Appendix 10.1 of the protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
(2) Participant must have received at least one infusion of 177Lu-IPN01072 in Study OPS-C- 001
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 19
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 19
There are no exclusion criteria in this safety surveillance study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the incidence of second primary haematological and non-haematological malignancies;Secondary Objective: • To evaluate the long-term safety profile of 177Lu-IPN01072<br>• To evaluate the overall survival;Primary end point(s): Presence of participants with second primary haematological and non-haematological malignancies;Timepoint(s) of evaluation of this end point: Screening Visit, Safety Follow-up Period Every 3 Months, end of study / early withdrawal visit
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Incidence of treatment-related adverse events of any grade according to the National Cancer Institute–Common Terminology Criteria for<br>Adverse Events Version 5.0, including any treatment-related serious adverse events, as assessed by the investigators<br>• Changes over time in laboratory tests (haematology and biochemistry)<br>• Overall survival defined as the time from the first dose of 177Lu-IPN01072 until death from any cause;Timepoint(s) of evaluation of this end point: Screening Visit, Safety Follow-up Period Every 3 Months, end of study / early withdrawal visit