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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Proportion of participants who achieve complete or partial response based on radiographic assessments. | 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) |
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Inclusion Criteria:
Participants can join the study if they meet all of the following conditions:
Exclusion Criteria:
Participants cannot join the study if:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ipsen Clinical Study Enquiries | Contact | See e mail | clinical.trials@ipsen.com |
| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universitaet Graz | Recruiting | Graz | Austria | |||
| Kepler Universitaetsklinikum GmbH Linz |
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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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).
Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).
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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). |
| 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). | 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. | 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. | Up to 18 months |
| Duration of treatment (DoT) | Time from first dose to last dose of cabozantinib. | 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. | 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. | 3 Months After Therapy Switch |
| Chromogranin A Levels | Chromogranin A blood levels measured during routine care. | Baseline and Every 3 Months up to 18 Months |
| Neuron-Specific Enolase blood levels. | Neuron-Specific Enolase blood levels measured during routine care. | Baseline and Every 3 Months up to 18 Months |
| Time to next treatment | Time from first dose of cabozantinib to initiation of subsequent therapy. | Up to 18 Months |
| Progression-Free Survival (PFS) | Time from first dose of cabozantinib to disease progression or death from any cause. | Up to 18 Months |
| Progression-Free Survival Rate at 12 and 18 Months | Number of participants without disease progression or death. | At 12 and 18 Months |
| Not yet recruiting |
| Linz |
| Austria |
| Medizinische Universität Wien | Recruiting | Vienna | Austria |
| MVZ am Klinikum Aschaffenburg | Recruiting | Aschaffenburg | Germany |
| Charité - Universitaetsmedizin Berlin | Recruiting | Berlin | Germany |
| DRK Kliniken Berlin | Recruiting | Berlin | Germany |
| Evangelische Lungenklinik Berlin | Recruiting | Berlin | Germany |
| Krankenhaus St. Joseph-Stift Bremen GmbH | Recruiting | Bremen | Germany |
| Klinikum Chemnitz | Not yet recruiting | Chemnitz | Germany |
| MVZ fuer Haematologie und Onkologie Koeln am Sachsenring | Not yet recruiting | Cologne | Germany |
| pioh Studien und Mangement GbR | Recruiting | Cologne | Germany |
| Gemeinschaftspraxis Haematologie - Onkologie | Recruiting | Dresden | Germany |
| Technische Univiersitaet (TU) Dresden | Recruiting | Dresden | Germany |
| Universitaetsklinikum Erlangen | Not yet recruiting | Erlangen | Germany |
| Universitaetsklinikum Essen | Recruiting | Essen | Germany |
| Krankenhaus Nordwest | Not yet recruiting | Frankfurt | Germany |
| Uniklinikum Frankfurt | Not yet recruiting | Frankfurt am Main | Germany |
| Universitaetsklinikum Freiburg | Not yet recruiting | Freiburg im Breisgau | Germany |
| Universitaetsklinikum Giessen-Marburg | Not yet recruiting | Giesen | Germany |
| Universitaetsmedizin Goettingen | Recruiting | Goettigen | Germany |
| Asklepios Kliniken Hamburg | Not yet recruiting | Hamburg | Germany |
| Universitaetsklinikum Hamburg-Eppendorf | Recruiting | Hamburg | Germany |
| Studienzentrum UnterEms | Not yet recruiting | Leer | Germany |
| MVZ Leipzig Mitte, MVZ Delitzsch | Not yet recruiting | Leipzig | Germany |
| Universiteatsmedizin Leipzig | Not yet recruiting | Leipzig | Germany |
| RKH Kliniken Ludwigsburg-Bietigheim gGmbH | Recruiting | Ludwigsburg | Germany |
| Philipps-Universitaet Marburg | Recruiting | Marburg | Germany |
| Johannes Wesling Klinikum Minden der Muehlenkreiskliniken AoeR | Not yet recruiting | Minden | Germany |
| MVZ Muelheim an der Ruhr GmbH | Recruiting | Mülheim | Germany |
| MVZ Onkologie Klinikum Osnabrueck GmbH | Not yet recruiting | Osnabrück | Germany |
| Universitaestklinikum Saarbruecken | Not yet recruiting | Saarbrücken | Germany |
| Universitätsklinikum Tuebingen | Recruiting | Tübingen | Germany |
| Medizinische Studiengesellschaft Nord-West | Recruiting | Westerstede | Germany |
| Universitaetsklinikum Wuerzburg | Recruiting | Würzburg | Germany |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
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