Status:
ACTIVE_NOT_RECRUITING
A Trial of Cabozantinib in Patients With Advanced, Low Proliferative NEN G3
Lead Sponsor:
Karsten Gavenis
Conditions:
Neuroendocrine Tumors
Neuroendocrine Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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%.
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2024
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04524208
Start Date
March 1 2021
End Date
October 31 2024
Last Update
August 13 2024
Active Locations (15)
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1
Medizinische Universität Wien
Vienna, Austria
2
University Medical Center Göttingen
Göttingen, Lower Saxony, Germany, 37075
3
Zentralklinik Bad Berka GmbH
Bad Berka, Germany, 99437
4
Universitätsklinikum Carl Gustav Carus
Dresden, Germany, 01307