Neuroendocrine TumorsCaboLifeNCT07314164
Study of Cabozantinib in Participants With Neuroendocrine Tumors Who Have Already Received Prior Treatment
An observational study of Neuroendocrine Tumors, run by Ipsen at 41 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- How many people
- 150 participants
- Where
- 41 sitesin 2 countries
- Study dates
- 17 Dec 2025to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
41 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
41 sites in 2 countries
Germany38 sites, 38 recruiting
- Recruiting
MVZ am Klinikum Aschaffenburg
Aschaffenburg
- Recruiting
Charité - Universitaetsmedizin Berlin
Berlin
- Recruiting
DRK Kliniken Berlin
Berlin
- Recruiting
Evangelische Lungenklinik Berlin
Berlin
- Not yet recruiting
Johanniter-Kliniken Bonn
Bonn
- Recruiting
Krankenhaus St. Joseph-Stift Bremen GmbH
Bremen
- Not yet recruiting
Klinikum Chemnitz
Chemnitz
- Recruiting
MVZ fuer Haematologie und Onkologie Koeln am Sachsenring
Cologne
- Recruiting
pioh Studien und Mangement GbR
Cologne
- Recruiting
Gemeinschaftspraxis Haematologie - Onkologie
Dresden
- Recruiting
Technische Univiersitaet (TU) Dresden
Dresden
- Recruiting
Universitaetsklinikum Erlangen
Erlangen
- Recruiting
Universitaetsklinikum Essen
Essen
- Not yet recruiting
Krankenhaus Nordwest
Frankfurt
- Not yet recruiting
Uniklinikum Frankfurt
Frankfurt am Main
- Recruiting
Universitaetsklinikum Freiburg
Freiburg im Breisgau
- Not yet recruiting
Universitaetsklinikum Giessen-Marburg
Giesen
- Recruiting
Universitaetsmedizin Goettingen
Goettigen
- Not yet recruiting
Asklepios Kliniken Hamburg
Hamburg
- Recruiting
Universitaetsklinikum Hamburg-Eppendorf
Hamburg
- Not yet recruiting
Universitaetsklinikum Heidelberg
Heidelberg
- Not yet recruiting
UKSH Kiel
Kiel
- Not yet recruiting
Studienzentrum UnterEms
Leer
- Not yet recruiting
MVZ Leipzig Mitte, MVZ Delitzsch
Leipzig
- Not yet recruiting
Universiteatsmedizin Leipzig
Leipzig
- Not yet recruiting
UKSH Luebeck
Lübeck
- Recruiting
RKH Kliniken Ludwigsburg-Bietigheim gGmbH
Ludwigsburg
- Not yet recruiting
Universitaetsmedizin Mainz
Mainz
- Recruiting
Philipps-Universitaet Marburg
Marburg
- Recruiting
Johannes Wesling Klinikum Minden der Muehlenkreiskliniken AoeR
Minden
- Recruiting
MVZ Muelheim an der Ruhr GmbH
Mülheim
- Not yet recruiting
TUM Klinikum Muenchen
München
- Not yet recruiting
Universitaetsklinikum Muenster
Münster
- Not yet recruiting
MVZ Onkologie Klinikum Osnabrueck GmbH
Osnabrück
- Not yet recruiting
Universitaestklinikum Saarbruecken
Saarbrücken
- Recruiting
Universitätsklinikum Tuebingen
Tübingen
- Recruiting
Medizinische Studiengesellschaft Nord-West
Westerstede
- Recruiting
Universitaetsklinikum Wuerzburg
Würzburg
Austria3 sites, 3 recruiting
- Recruiting
Medizinische Universitaet Graz
Graz
- Not yet recruiting
Kepler Universitaetsklinikum GmbH Linz
Linz
- Recruiting
Medizinische Universität Wien
Vienna
About this study
Official title: CaboLife: A Prospective Non-Interventional Study on Effectiveness and Safety of Cabozantinib in Real-Life Setting for Previously Treated Patients With Neuroendocrine Tumour
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.
Read more
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.
- Conditions
- Neuroendocrine Tumors
- Medical subject headings
- Neuroendocrine Tumors
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 6 Months
Secondary outcomes (13)
Objective Response Rate (ORR)
Proportion of participants who achieve complete or partial response based on radiographic assessments.
Measured: 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)
A validated 30-item questionnaire designed to assess the general health-related quality of life of cancer patients. It includes: 5 functional scales (physical, role, emotional, cognitive, social), 3 symptom scales (fatigue, nausea/vomiting, pain) a global health status/QoL scale and several single items (e.g., dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
Measured: 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)
A 21-item module developed to supplement the QLQ-C30 for patients with gastrointestinal neuroendocrine tumors (GI-NETs). It includes 5 scales (Endocrine symptoms, Gastrointestinal symptoms, Treatment-related side effects, Social functioning, Disease-related worries) and 5 single items (weight loss, weight gain, muscle and/or bone pain, information, sexual functioning).
Measured: 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)
An Adverse event (AE) is any untoward medical occurrence, temporally associated with the use of study intervention, whether or not related to the study intervention.
Measured: Up to 18 Months
Percentage of participants with any dose modification due to AEs.
Percentage of participants who experienced at least one dose reduction, interruption, or discontinuation due to adverse events during the study period.
Measured: Up to 18 months
Duration of treatment (DoT)
Time from first dose to last dose of cabozantinib.
Measured: Up to 18 Months
Percentage of participants switching to a new line of therapy
Percentage of participants who initiated a new line of therapy during the study period. The type of therapy received after switch will be reported descriptively and is not considered a formal outcome measure.
Measured: Up to 18 Months
Disease control rate after switch to next line of therapy
Proportion of participants achieving complete response, partial response, or stable disease within 3 months after switching to a new therapy, based on radiographic assessment performed as part of routine care.
Measured: 3 Months After Therapy Switch
Chromogranin A Levels
Chromogranin A blood levels measured during routine care.
Measured: Baseline and Every 3 Months up to 18 Months
Neuron-Specific Enolase blood levels.
Neuron-Specific Enolase blood levels measured during routine care.
Measured: Baseline and Every 3 Months up to 18 Months
Time to next treatment
Time from first dose of cabozantinib to initiation of subsequent therapy.
Measured: Up to 18 Months
Progression-Free Survival (PFS)
Time from first dose of cabozantinib to disease progression or death from any cause.
Measured: Up to 18 Months
Progression-Free Survival Rate at 12 and 18 Months
Number of participants without disease progression or death.
Measured: At 12 and 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start17 Dec 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314164
- Sponsor's protocol ID
- CLIN-60000-467
- Acronym
- CaboLife
- Status last verified
- Sep 2026
- First submitted
- 18 Dec 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CaboLife: A Prospective Non-Interventional Study on Effectiveness and Safety of Cabozantinib in Real-Life Setting for Previously Treated Patients With Neuroendocrine Tumour
- ClinicalTrials.gov ID
- NCT07314164
- Acronym / sponsor ID
- CaboLife / CLIN-60000-467
- Conditions
- Neuroendocrine Tumors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease Control Rate (DCR)
Time frame: At 6 Months
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.
13 secondary outcomes
Objective Response Rate (ORR)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Up to 18 Months
Percentage of participants with any dose modification due to AEs.
Time frame: Up to 18 months
Duration of treatment (DoT)
Time frame: Up to 18 Months
Percentage of participants switching to a new line of therapy
Time frame: Up to 18 Months
Disease control rate after switch to next line of therapy
Time frame: 3 Months After Therapy Switch
Chromogranin A Levels
Time frame: Baseline and Every 3 Months up to 18 Months
Neuron-Specific Enolase blood levels.
Time frame: Baseline and Every 3 Months up to 18 Months
Time to next treatment
Time frame: Up to 18 Months
Progression-Free Survival (PFS)
Time frame: Up to 18 Months
Progression-Free Survival Rate at 12 and 18 Months
Time frame: At 12 and 18 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ipsen Medical Director study director
Ipsen
41 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine Tumors, run by Ipsen at 41 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ipsen Clinical Study Enquiries (See e mail, clinical.trials@ipsen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Control Rate (DCR) (time frame: At 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.