An observational study in Neuroendocrine Tumors, sponsored by Ipsen. Recruiting at 38 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Ipsen · Observational
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.
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.
Participants can join the study if they meet all of the following conditions:
Exclusion Criteria:
Participants cannot join the study if:
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.
Time frame: At 6 Months
Objective Response Rate (ORR)
Proportion of participants who achieve complete or partial response based on radiographic assessments.
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)
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).
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)
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).
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)
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.
Time frame: 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.
Time frame: Up to 18 months
Duration of treatment (DoT)
Time from first dose to last dose of cabozantinib.
Time frame: 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.
Time frame: 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.
Time frame: 3 Months After Therapy Switch
Chromogranin A Levels
Chromogranin A blood levels measured during routine care.
Time frame: Baseline and Every 3 Months up to 18 Months
Neuron-Specific Enolase blood levels.
Neuron-Specific Enolase blood levels measured during routine care.
Time frame: Baseline and Every 3 Months up to 18 Months
Time to next treatment
Time from first dose of cabozantinib to initiation of subsequent therapy.
Time frame: Up to 18 Months
Progression-Free Survival (PFS)
Time from first dose of cabozantinib to disease progression or death from any cause.
Time frame: Up to 18 Months
Progression-Free Survival Rate at 12 and 18 Months
Number of participants without disease progression or death.
Time frame: At 12 and 18 Months
Plan to share: 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.
No publications or documents are linked to this record.
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