We will include patients with NET G3 and upto four prior antitumoral treatment lines and NEC Ki67 low after failure of standard treatment with conventional chemotherapy.
Conditions
Interventions
Product Name: Cabometyx
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Cabozantinib
CAS Number: 849217-68-1
Sponsors
Universitätsmedizin Göttingen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with histologically confirmed diagnosis of neuroendocrine neoplasia; 2. Tumor proliferation rate has to be > Ki67 20% and = Ki67 60% (local assessment); 3. Male, female, or diverse patients aged = 18 years without upper age limit; 4. Patients with up to four different antitumoral therapies 5. At least one measurable tumor lesion in CT or MRI scan; 6. Newly diagnosed or progressive disease assessed per RECIST criteria 1.1; 7. Patients must have a performance status of ECOG 0-2; 8. Patients must have a life expectancy of more than 3 months; 9. Hb> 9 g/dl; 10. Platelets >80T/µl; 11. White blood cells >3T/µL; 12. Total bilirubin 40mL/min/1.73m2; 15. BUN =65 years) yes F.1.3.1 Number of subjects for this age range 17
Exclusion criteria
Exclusion criteria: 1. Patients with Mixed Neuroendocrine-Non-neuroendocrine Neoplasia (MINEN); 2. Patients with former treatment with TKI or VEGF receptor antagonist; 3. Patients with additional malignancy 160/110 mmHg); 10. Patients with severely impaired lung function; 11. Patients with history of organ transplant (exclusion: cornea transplantation); 12. Patients with clinical apparent acute or chronic gastric ulceration; 13. Patients with history of hemophilia; 14. Patients with surgery at the GI tract within the last 12 weeks; 15. Patients with patients with uncontrolled inflammatory bowel disease; 16. Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed 17. Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial; 18. Previous participation in this trial 19. concomitant use of therapeutic anticoagulation or strong CYP3A4 inducers or inhibitors (e.g. amiodarone); 20. Known or persistent abuse of medication, drugs or alcohol; 21. Person who is in a relationship of dependence/employment with the sponsor or the investigator; 22. Current or planned pregnancy, nursing period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the efficacy of Cabozantinib treatment;Secondary Objective: Evaluate short- and long term efficacy of Cabozantinib treatment, evaluate necessary exposure time, assess quality-of-life during and after Cabozantinib treatment, and to assess general safety of Cabozantinib treatment ;Primary end point(s): Disease control rate (DCR) (Complete Response, CR + Partial Response, PR + Stable Disease, SD);Timepoint(s) of evaluation of this end point: 6 months after treatment start | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Disease control rate (DCR). Progression free survival (PFS) and overall survival (OS). Time on drug (TOD). EORTC QLQ-C30 Quality of Life Questionnaire monthly. Serious adverse events and adverse events, Data Safety Monitoring Board (DSMB) after 20 patients.;Timepoint(s) of evaluation of this end point: 3 and 12 months after treatment start. For the QoL: monthly for 12 months after treatment start and after 15 months | — |
Countries
Austria, Germany
Contacts
Public ContactCabonen-Projectmanagement
Universitätsmedizin Göttingen
Outcome results
None listed