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JOURNAL ONKOLOGIE – STUDIE
CABONEN

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

Rekrutierend

NCT-Nummer:
NCT04524208

Studienbeginn:
März 2021

Letztes Update:
21.03.2024

Wirkstoff:
Cabozantinib

Indikation (Clinical Trials):
Neuroendocrine Tumors, Carcinoma, Neuroendocrine

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Karsten Gavenis

Collaborator:
-

Studienleiter

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

Kontakt

Studienlocations
(3 von 15)

University Medical Center Göttingen
37075 Göttingen
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Alexander Otto König, PD Dr.
E-Mail: alexander.koenig@med.uni-goettingen.de» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

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%.

Ein-/Ausschlusskriterien

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;

Studien-Rationale

Primary outcome:

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:

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.

Geprüfte Regime

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

Quelle: ClinicalTrials.gov


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