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NCT Number: NCT07314164

Study of Cabozantinib in Participants With Neuroendocrine Tumors Who Have Already Received Prior Treatment

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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Key information

Conditions

Neuroendocrine Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medizinische Universitaet Graz, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: Up to 18 Months

    Proportion of participants who achieve complete or partial response based on radiographic assessments.

  2. 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

    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).

  3. 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

    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).

  4. Percentage of participants experiencing Adverse Events (AEs), non-serious, drug-related, or serious Adverse Events (SAEs)

    Time frame: Up to 18 Months

    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.

  5. Percentage of participants with any dose modification due to AEs.

    Time frame: Up to 18 months

    Percentage of participants who experienced at least one dose reduction, interruption, or discontinuation due to adverse events during the study period.

  6. Duration of treatment (DoT)

    Time frame: Up to 18 Months

    Time from first dose to last dose of cabozantinib.

  7. Percentage of participants switching to a new line of therapy

    Time frame: Up to 18 Months

    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.

  8. Disease control rate after switch to next line of therapy

    Time frame: 3 Months After Therapy Switch

    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.

  9. Chromogranin A Levels

    Time frame: Baseline and Every 3 Months up to 18 Months

    Chromogranin A blood levels measured during routine care.

  10. Neuron-Specific Enolase blood levels.

    Time frame: Baseline and Every 3 Months up to 18 Months

    Neuron-Specific Enolase blood levels measured during routine care.

  11. Time to next treatment

    Time frame: Up to 18 Months

    Time from first dose of cabozantinib to initiation of subsequent therapy.

  12. Progression-Free Survival (PFS)

    Time frame: Up to 18 Months

    Time from first dose of cabozantinib to disease progression or death from any cause.

  13. Progression-Free Survival Rate at 12 and 18 Months

    Time frame: At 12 and 18 Months

    Number of participants without disease progression or death.

Study contacts

Contact information is provided by the study sponsor or research team.

Ipsen Clinical Study Enquiries

CONTACT

[email protected]

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Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

CaboLife: A Prospective Non-Interventional Study on Effectiveness and Safety of Cabozantinib in Real-Life Setting for Previously Treated Patients With Neuroendocrine Tumour

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jan 2, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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