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

NCT ID: NCT04524208

Last Updated: 2024-08-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2024-10-31

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%.

Conditions

Neuroendocrine Tumors; Neuroendocrine Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment-Arm

Group Type: EXPERIMENTAL

Cabozantinib

Intervention Type: DRUG

Cabozantinib is administered orally at the dose of 60 mg per day..

Interventions

Cabozantinib

Cabozantinib is administered orally at the dose of 60 mg per day..

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patient with histologically confirmed diagnosis of neuroendocrine neoplasia;

2. Tumor proliferation rate has to be between Ki67 20% to 60% (local assessment);

3. Male, female, or diverse patients aged > 18 years without upper age limit;

4. At least one measurable tumor lesions in CT or MRI scan;

5. Newly diagnosed or progressive disease assessed per RECIST criteria 1.1;

6. Patients must have a performance status of ECOG 0-2;

7. Patients must have a life expectancy of more than 3 months;

8. Hb> 9 mg/dl;

9. platelets >80T/µl;

10. white blood cells >3T/μL;

11. total bilirubin <3mg/dl;

12. AST and ALT <4xN;

13. Serum creatinine <2mg/dl, eGFR >40mL/min/1.73m2;

14. BUN <5xN;

15. lipase <3xN;

16. albumin ≥2.8 g/dL;

17. PT/PTT ≤ 1.5 × ULN;

18. urine protein: creatinine ratio ≤ 1;

19. Written informed consent obtained according to international guidelines and local laws;

20. Ability to understand the nature of the trial and the trial related procedures and to comply with them;

Exclusion Criteria

1. Patients younger than 18 years;

2. Patients with Mixed Neuroendocrine-Non-neuroendocrine Neoplasia (MINEN);

3. Patients with former treatment with TKI or VEGF receptor antagonist;

4. Patients with additional malignancy <5 years in medical history (exclusion: non-invasive skin cancer);

5. Patients with symptomatic brain metastases;

6. Patients with Known HIV infection, infectious hepatitis (type A, B or C) or another uncontrolled infection;

7. Patients with Known hypersensitivity to Cabozantinib or contraindications for treatment with Cabozantinib according to Summary of Product Characteristics (SmPC);

8. Patients with class III or IV congestive heart failure;

9. Patients with QTc more than 500 ms or 140% of normal range according to age;

10. Patients with uncontrolled hypertension;

11. Patients with severely impaired lung function;

12. Patients with history of organ transplant (exclusion: cornea transplantation);

13. Patients with clinical apparent acute or chronic gastric ulceration;

14. Patients with history of hemophilia;

15. Patients with surgery at the GI tract within the last 12 weeks;

16. Patients with patients with uncontrolled inflammatory bowel disease;

17. Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed

18. Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial;

19. Previous participation in this trial

20. concomitant use of therapeutic anticoagulation or strong CYP3A4 inducers or inhibitors (e.g. amiodarone);

21. Known or persistent abuse of medication, drugs or alcohol;

22. Person who is in a relationship of dependence/employment with the sponsor or the investigator;

23. Patients who cannot give informed consent;

24. Current or planned pregnancy, nursing period;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karsten Gavenis

OTHER

Sponsor Role: lead

Responsible Party

Karsten Gavenis

Project Manager

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Alexander König, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Göttingen

Locations

Medizinische Universität Wien

Vienna, , Austria

University Medical Center Göttingen

Göttingen, Lower Saxony, Germany

Zentralklinik Bad Berka GmbH

Bad Berka, , Germany

Universitätsklinikum Carl Gustav Carus

Dresden, , Germany

Universitätsklinikum Erlangen

Erlangen, , Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, , Germany

Universitätsklinikum Halle

Halle, , Germany

Asklepios St. Georg

Hamburg, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

Klinikum Heidelberg

Heidelberg, , Germany

Universitätsmedizin Mannheim

Mannheim, , Germany

Universitätsklinikum Gießen und Marburg GmbH

Marburg, , Germany

Johannes-Wesling-Klinikum Minden

Minden, , Germany

Klinikum Ulm

Ulm, , Germany

Universitätsklinik Würzburg

Würzburg, , Germany

Countries

Austria; Germany

Other Identifiers

02679

Identifier Type: -

Identifier Source: org_study_id