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CABONEN – a phase II trial of Cabozantinib in patients with advanced, low proliferative NEN G3
EU CTIS ID: 2024-510863-50-00
What this study is testing
Evaluate the efficacy of Cabozantinib treatment
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients with histologically confirmed diagnosis of neuroendocrine neoplasia
- 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
You likely can't join if
- Patients with Mixed Neuroendocrine-Non-neuroendocrine Neoplasia (MINEN)
- 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
See the full eligibility criteria
- Patients with histologically confirmed diagnosis of neuroendocrine neoplasia
- 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 ration ≤ 1 (Note: if proteinuria < 2g/l and increased proteinuria is ruled out by an urine teststick the protein:creatinine ratio does not need to be determined)
- Tumor proliferation rate has to be > Ki67 20% and ≤ Ki67 60% (local assessment)
- 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
- Male, female, or diverse patients aged ≥ 18 years without upper age limit
- Patients with upto four different antitumoral therapies
- At least one measurable tumor lesion 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 g/dl
- Patients with Mixed Neuroendocrine-Non-neuroendocrine Neoplasia (MINEN)
- 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 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)
- Patients with former treatment with TKI or VEGF receptor antagonist
- Known or persistent abuse of medication, drugs or alcohol
- Person who is in a relationship of dependence/employment with the sponsor or the investigator
- Current or planned pregnancy, nursing period
- Patients with additional malignancy <5 years in medical history (exclusion: non-invasive skin cancer)
- Patients with symptomatic brain metastases
- Patients with known HIV infection, acute and chronic-active 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 prolonged QTc (for woman more than 470 ms, for men 450 ms)
- Patients with uncontrolled hypertension (despite anti-hypertensive medication RR:>160/110 mmHg)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.