Back to resultsA Long-term Safety Surveillance Study in Participants Previously Treated With 177Lu-IPN01072
Primary Purpose
Neuroendocrine Tumors
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Data collection
Sponsored by
About this trial
This is an interventional other trial for Neuroendocrine Tumors
Eligibility 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.
Sites / Locations
- Peter Maccallum Cancer Center
- Ramsay Hollywood Private Hospital
- Medical University of Vienna
- Aarhus University Hospital
- Hôtel Dieu de Nantes
- University Hospital Basel
- Royal Free Hospital London
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Data collection
Arm Description
Outcomes
Primary Outcome Measures
Proportion of participants with second primary haematological and non-haematological malignancies.
Secondary Outcome Measures
Proportion of treatment-related adverse events of any grade.
Adverse events assessed according to the National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE Version 5.0), including any treatment-related serious adverse events, as assessed by the investigators.
Changes over time in laboratory tests (haematology)
Laboratory parameters (Platelet count, Haemoglobin and White Blood Cells count with differential) will be graded according to the NCI-CTCAE Version 5.0.
Changes over time in laboratory tests (biochemistry)
Laboratory parameters (Creatinine) will be graded according to the NCI-CTCAE Version 5.0.
Overall survival defined as the time from the first dose of 177Lu-IPN01072 until death from any cause.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05017662
Brief Title
A Long-term Safety Surveillance Study in Participants Previously Treated With 177Lu-IPN01072
Official Title
A Multicentre Surveillance Study to Evaluate the Long-term Safety in Participants Who Have Been Previously Treated With 177Lu-IPN01072 in an Ipsen-sponsored Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 14, 2021 (Actual)
Primary Completion Date
March 3, 2025 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumors
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Data collection
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Data collection
Intervention Description
Participants will have surveillance visits every 3 months up to 5 years after their first dose of 177Lu-IPN01072 in Study OPS-C-001.
Primary Outcome Measure Information:
Title
Proportion of participants with second primary haematological and non-haematological malignancies.
Time Frame
During the whole study period (approximately 5 years).
Secondary Outcome Measure Information:
Title
Proportion of treatment-related adverse events of any grade.
Description
Adverse events assessed according to the National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE Version 5.0), including any treatment-related serious adverse events, as assessed by the investigators.
Time Frame
During the whole study period (approximately 5 years).
Title
Changes over time in laboratory tests (haematology)
Description
Laboratory parameters (Platelet count, Haemoglobin and White Blood Cells count with differential) will be graded according to the NCI-CTCAE Version 5.0.
Time Frame
During the whole study period (approximately 5 years).
Title
Changes over time in laboratory tests (biochemistry)
Description
Laboratory parameters (Creatinine) will be graded according to the NCI-CTCAE Version 5.0.
Time Frame
During the whole study period (approximately 5 years).
Title
Overall survival defined as the time from the first dose of 177Lu-IPN01072 until death from any cause.
Time Frame
During the whole study period (approximately 5 years).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Peter Maccallum Cancer Center
City
Melbourne
ZIP/Postal Code
3002
Country
Australia
Facility Name
Ramsay Hollywood Private Hospital
City
Perth
ZIP/Postal Code
6009
Country
Australia
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Hôtel Dieu de Nantes
City
Nantes
ZIP/Postal Code
44093 Cedex 1
Country
France
Facility Name
University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Royal Free Hospital London
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
IPD Sharing Time Frame
Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
IPD Sharing Access Criteria
Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
IPD Sharing URL
https://vivli.org/members/ourmembers/
Learn more about this trial
A Long-term Safety Surveillance Study in Participants Previously Treated With 177Lu-IPN01072
We'll reach out to this number within 24 hrs