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

Sponsor
Karsten Gavenis (Other)
Overall Status
Recruiting
CT.gov ID
NCT04524208
Collaborator
(none)
40
Enrollment
6
Locations
1
Arm
28
Anticipated Duration (Months)
6.7
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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%.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
CABONEN - A Phase II Trial of Cabozantinib in Patients With Advanced, Low Proliferative NEN G3
Actual Study Start Date :
Mar 1, 2021
Anticipated Primary Completion Date :
May 31, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment-Arm

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

Outcome Measures

Primary Outcome Measures

  1. Evaluate the efficacy of Cabozantinib treatment via DCR after 6 months. [6 months]

    Disease control rate (DCR) 6 months after treatment start .

Secondary Outcome Measures

  1. Evaluate short- and long term efficacy of Cabozantinib treatment via DCR. [12 months]

    DCR 3 and 12 months after treatment start.

  2. Evaluate short- and long term efficacy of Cabozantinib treatment via ORR. [12 months]

    Objective response rate (ORR) 3, 6 and 12 months after treatment start and best objective response rate.

  3. Evaluate short- and long term efficacy of Cabozantinib treatment via PFS. [24 months]

    Progression free survival (PFS).

  4. Evaluate short- and long term efficacy of Cabozantinib treatment via OS. [24 months]

    Overall survival (OS).

  5. Evaluate exposure time. [12 months]

    Time on drug (TOD).

  6. Assess quality-of-life during and after Cabozantinib treatment. [15 months]

    EORTC QLQ-C30 Quality of Life Questionnaire monthly for 12 months after treatment start and after 15 months. Different questions regarding Quality of Life on a scale of 1 - 4. The lower the numbers, the better the quality of Life.

Other Outcome Measures

  1. Safety of Cabozantinib via AE and SAE assessment. [24 months]

    Adverse events and serious adverse events will be assessed in contingency tables.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Medical Center Göttingen Göttingen Lower Saxony Germany 37075
2 Zentralklinik Bad Berka GmbH Bad Berka Germany 99437
3 Universitätsklinikum Carl Gustav Carus Dresden Germany 01307
4 Universitätsklinikum Freiburg Freiburg Germany 79106
5 Universitätsklinikum Halle Halle Germany
6 Universitätsklinikum Gießen und Marburg GmbH Marburg Germany 35043

Sponsors and Collaborators

  • Karsten Gavenis

Investigators

  • Principal Investigator: Alexander König, PD Dr., University Medical Center Göttingen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Karsten Gavenis, Project Manager, University Medical Center Goettingen
ClinicalTrials.gov Identifier:
NCT04524208
Other Study ID Numbers:
  • 02679
First Posted:
Aug 24, 2020
Last Update Posted:
Jul 1, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neuroendocrine Tumors
Carcinoma, Neuroendocrine

Study Results

No Results Posted as of Jul 1, 2022