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

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ClinicalTrials.gov Identifier: NCT04524208
Recruitment Status : Not yet recruiting
First Posted : August 24, 2020
Last Update Posted : August 24, 2020
Sponsor:
Information provided by (Responsible Party):
Karsten Gavenis, University Medical Center Goettingen

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
Neuroendocrine Tumors Neuroendocrine Carcinoma Drug: Cabozantinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment-Arm Drug: Cabozantinib
Cabozantinib is administered orally at the dose of 60 mg per day..




Primary Outcome Measures :
  1. Evaluate the efficacy of Cabozantinib treatment via DCR after 6 months. [ Time Frame: 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. [ Time Frame: 12 months ]
    DCR 3 and 12 months after treatment start.

  2. Evaluate short- and long term efficacy of Cabozantinib treatment via ORR. [ Time Frame: 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. [ Time Frame: 24 months ]
    Progression free survival (PFS).

  4. Evaluate short- and long term efficacy of Cabozantinib treatment via OS. [ Time Frame: 24 months ]
    Overall survival (OS).

  5. Evaluate exposure time. [ Time Frame: 12 months ]
    Time on drug (TOD).

  6. Assess quality-of-life during and after Cabozantinib treatment. [ Time Frame: 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. [ Time Frame: 24 months ]
    Adverse events and serious adverse events will be assessed in contingency tables.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04524208


Contacts
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Contact: Jessica Halfen, Dr. +49 (0)511 39 62362 jessica.halfen@med.uni-goettingen.de

Sponsors and Collaborators
Karsten Gavenis
Investigators
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Principal Investigator: Alexander König, PD Dr. University Medical Center Göttingen
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Responsible Party: Karsten Gavenis, Project Manager, University Medical Center Goettingen
ClinicalTrials.gov Identifier: NCT04524208    
Other Study ID Numbers: 02679
First Posted: August 24, 2020    Key Record Dates
Last Update Posted: August 24, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Carcinoma, Neuroendocrine
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial