A Trial of Cabozantinib in Patients With Advanced, Low Proliferative NEN G3 (CABONEN)

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    40
  • sponsor
    Karsten Gavenis
Updated on 7 October 2022
progressive disease
cabozantinib
ki-67

Summary

The main objective of this clinical trial represents the evaluation of efficacy of the tyrosine kinase inhibitor Cabozantinib in patients with NEN G3 with a proliferation rate of Ki67 20 - 60%.

Details
Condition Neuroendocrine Tumors, Neuroendocrine Carcinoma
Treatment Cabozantinib
Clinical Study IdentifierNCT04524208
SponsorKarsten Gavenis
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient with histologically confirmed diagnosis of neuroendocrine neoplasia
Tumor proliferation rate has to be between Ki67 20% to 60% (local assessment)
Male, female, or diverse patients aged > 18 years without upper age limit
At least one measurable tumor lesions in CT or MRI scan
Newly diagnosed or progressive disease assessed per RECIST criteria 1.1
Patients must have a performance status of ECOG 0-2
Patients must have a life expectancy of more than 3 months
Hb> 9 mg/dl
platelets >80T/µl
white blood cells >3T/μL
total bilirubin <3mg/dl
AST and ALT <4xN
Serum creatinine <2mg/dl, eGFR >40mL/min/1.73m2
BUN <5xN
lipase <3xN
albumin ≥2.8 g/dL
PT/PTT ≤ 1.5 × ULN
urine protein: creatinine ratio ≤ 1
Written informed consent obtained according to international guidelines and local laws
Ability to understand the nature of the trial and the trial related procedures and to comply with them

Exclusion Criteria

Patients younger than 18 years
Patients with Mixed Neuroendocrine-Non-neuroendocrine Neoplasia (MINEN)
Patients with former treatment with TKI or VEGF receptor antagonist
Patients with additional malignancy <5 years in medical history (exclusion: non-invasive skin cancer)
Patients with symptomatic brain metastases
Patients with Known HIV infection, infectious hepatitis (type A, B or C) or another uncontrolled infection
Patients with Known hypersensitivity to Cabozantinib or contraindications for treatment with Cabozantinib according to Summary of Product Characteristics (SmPC)
Patients with class III or IV congestive heart failure
Patients with QTc more than 500 ms or 140% of normal range according to age
Patients with uncontrolled hypertension
Patients with severely impaired lung function
Patients with history of organ transplant (exclusion: cornea transplantation)
Patients with clinical apparent acute or chronic gastric ulceration
Patients with history of hemophilia
Patients with surgery at the GI tract within the last 12 weeks
Patients with patients with uncontrolled inflammatory bowel disease
Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed
Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial
Previous participation in this trial
concomitant use of therapeutic anticoagulation or strong CYP3A4 inducers or inhibitors (e.g. amiodarone)
Known or persistent abuse of medication, drugs or alcohol
Person who is in a relationship of dependence/employment with the sponsor or the investigator
Patients who cannot give informed consent
Current or planned pregnancy, nursing period
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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