Study of Cabozantinib in Participants With Neuroendocrine Tumors Who Have Already Received Prior Treatment
CaboLife: A Prospective Non-Interventional Study on Effectiveness and Safety of Cabozantinib in Real-Life Setting for Previously Treated Patients With Neuroendocrine Tumour
1 other identifier
observational
150
2 countries
28
Brief Summary
This study will assess how well cabozantinib works and how safe it is in adults with a type of cancer called neuroendocrine tumors (NETs). These tumors can appear in all parts of the body. All participants in this study have already received at least one treatment that affects the whole body to help manage their cancer, but their disease has continued to grow. The study will take place in regular hospitals and clinics in Germany and Austria. It will follow about 150 participants who are taking cabozantinib as part of their usual care. Doctors will collect information from routine medical visits, tests, and scans to see how the cancer responds to treatment and how long participants stay on cabozantinib. They will also look at side effects and how the treatment affects participants' quality of life. This is an observational study, which means that no extra tests or procedures will be done beyond what is normally used to care for participants with this condition.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2025
Typical duration for all trials
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 17, 2025
CompletedFirst Submitted
Initial submission to the registry
December 18, 2025
CompletedFirst Posted
Study publicly available on registry
January 2, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
April 30, 2026
April 1, 2026
1.9 years
December 18, 2025
April 29, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Disease Control Rate (DCR)
Proportion of participants who achieve complete response, partial response, or stable disease within 6 months of cabozantinib treatment, based on radiographic assessments performed as part of routine care.
At 6 Months
Secondary Outcomes (13)
Objective Response Rate (ORR)
Up to 18 Months
Change from baseline in global and subscale scores of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)
Baseline and Every 3 Months up to 18 Months
Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Gastrointestinal Neuroendocrine Tumors Module (EORTC QLQ-GINET21)
Baseline and Every 3 Months up to 18 Months
Percentage of participants experiencing Adverse Events (AEs), non-serious, drug-related, or serious Adverse Events (SAEs)
Up to 18 Months
Percentage of participants with any dose modification due to AEs.
Up to 18 months
- +8 more secondary outcomes
Eligibility Criteria
150 adult participants in Austria and Germany who are prescribed cabozantinib tablets for unresectable or metastatic, well differentiated extra-pancreatic (epNET) and pancreatic (pNET) neuroendocrine tumours who have progressed following at least one prior systemic therapy other than somatostatin analogues prior to entry into the study will be included.
You may qualify if:
- Participants can join the study if they meet all of the following conditions:
- Are 18 years or older and able to give informed consent.
- Have a physician-initiated decision to start treatment with cabozantinib for neuroendocrine tumors (NETs), made before joining the study.
- Have unresectable or metastatic, well-differentiated pancreatic (pNET) or extra-pancreatic neuroendocrine tumors (epNET).
- Have already received at least one prior systemic therapy, other than somatostatin analogues.
- Have signed a written informed consent form.
You may not qualify if:
- Participants cannot join the study if:
- They are currently participating in an interventional clinical trial, or have done so within the last 3 months before joining this study.
- They have a contraindication to cabozantinib treatment, based on the product's official prescribing information.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (28)
Medizinische Universitaet Graz
Graz, Austria
Kepler Universitaetsklinikum GmbH Linz
Linz, Austria
MVZ am Klinikum Aschaffenburg
Aschaffenburg, Germany
DRK Kliniken Berlin
Berlin, Germany
Evangelische Lungenklinik Berlin
Berlin, Germany
Krankenhaus St. Joseph-Stift Bremen GmbH
Bremen, Germany
Klinikum Chemnitz
Chemnitz, Germany
MVZ fuer Haematologie und Onkologie Koeln am Sachsenring
Cologne, Germany
pioh Studien und Mangement GbR
Cologne, Germany
Gemeinschaftspraxis Haematologie - Onkologie
Dresden, Germany
Technische Univiersitaet (TU) Dresden
Dresden, Germany
Universitaetsklinikum Essen
Essen, Germany
Krankenhaus Nordwest
Frankfurt, Germany
Uniklinikum Frankfurt
Frankfurt am Main, Germany
Universitaetsklinikum Giessen-Marburg
Giesen, Germany
Universitaetsmedizin Goettingen
Goettigen, Germany
Asklepios Kliniken Hamburg
Hamburg, Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, Germany
Studienzentrum UnterEms
Leer, Germany
MVZ Leipzig Mitte, MVZ Delitzsch
Leipzig, Germany
Universiteatsmedizin Leipzig
Leipzig, Germany
RKH Kliniken Ludwigsburg-Bietigheim gGmbH
Ludwigsburg, Germany
Philipps-Universitaet Marburg
Marburg, Germany
Johannes Wesling Klinikum Minden der Muehlenkreiskliniken AoeR
Minden, Germany
MVZ Muelheim an der Ruhr GmbH
Mülheim, Germany
Universitätsklinikum Tuebingen
Tübingen, Germany
Medizinische Studiengesellschaft Nord-West
Westerstede, Germany
Universitaetsklinikum Wuerzburg
Würzburg, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2025
First Posted
January 2, 2026
Study Start
December 17, 2025
Primary Completion (Estimated)
October 31, 2027
Study Completion (Estimated)
December 31, 2028
Last Updated
April 30, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the United States (US) and/or Europe (EU).
- Access Criteria
- Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).
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.