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

Study Purpose

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%.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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;

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04524208
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Karsten Gavenis
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

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

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Austria, Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Neuroendocrine Tumors, Neuroendocrine Carcinoma
Arms & Interventions

Arms

Experimental: Treatment-Arm

Interventions

Drug: - Cabozantinib

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Medizinische Universität Wien, Wien, Austria

Status

Recruiting

Address

Medizinische Universität Wien

Wien, ,

Site Contact

Barbara Kiesewetter, PD Dr. Dr.

[email protected]

+49 (0)511 39 60824

University Medical Center Göttingen, Göttingen, Lower Saxony, Germany

Status

Recruiting

Address

University Medical Center Göttingen

Göttingen, Lower Saxony, 37075

Site Contact

Alexander Otto König, PD Dr.

[email protected]

+49 (0)511 39 60824

Zentralklinik Bad Berka GmbH, Bad Berka, Germany

Status

Recruiting

Address

Zentralklinik Bad Berka GmbH

Bad Berka, , 99437

Site Contact

Dieter Hörsch

[email protected]

+49 (0)511 39 60824

Universitätsklinikum Carl Gustav Carus, Dresden, Germany

Status

Recruiting

Address

Universitätsklinikum Carl Gustav Carus

Dresden, , 01307

Site Contact

Anke Kröcher, Dr.

[email protected]

+49 (0)511 39 60824

Universitätsklinikum Erlangen, Erlangen, Germany

Status

Recruiting

Address

Universitätsklinikum Erlangen

Erlangen, ,

Site Contact

Marianne Pavel, Prof. Dr.

[email protected]

+49 (0)511 39 60824

Universitätsklinikum Freiburg, Freiburg, Germany

Status

Recruiting

Address

Universitätsklinikum Freiburg

Freiburg, , 79106

Site Contact

Steffen Heeg, Dr.

[email protected]

+49 (0)511 39 60824

Universitätsklinikum Halle, Halle, Germany

Status

Recruiting

Address

Universitätsklinikum Halle

Halle, ,

Site Contact

Sebastian Krug, PD Dr.

[email protected]

+49 (0)511 39 60824

Asklepios St. Georg, Hamburg, Germany

Status

Recruiting

Address

Asklepios St. Georg

Hamburg, ,

Site Contact

Ulrich F Pape, Dr.

[email protected]

+49 (0)511 39 60824

Medizinische Hochschule Hannover, Hannover, Germany

Status

Recruiting

Address

Medizinische Hochschule Hannover

Hannover, ,

Site Contact

Thomas Wirth, PD Dr.

[email protected]

+49 (0)511 39 60824

Klinikum Heidelberg, Heidelberg, Germany

Status

Recruiting

Address

Klinikum Heidelberg

Heidelberg, ,

Site Contact

Leonidas Apostolidis, Dr.

[email protected]

+49 (0)511 39 60824

Universitätsmedizin Mannheim, Mannheim, Germany

Status

Recruiting

Address

Universitätsmedizin Mannheim

Mannheim, ,

Site Contact

Nadine Schulte, Dr.

[email protected]

+49 (0)511 39 60824

Marburg, Germany

Status

Recruiting

Address

Universitätsklinikum Gießen und Marburg GmbH

Marburg, , 35043

Site Contact

Anja Rinke, PD Dr.

[email protected]

+49 (0)511 39 60824

Johannes-Wesling-Klinikum Minden, Minden, Germany

Status

Recruiting

Address

Johannes-Wesling-Klinikum Minden

Minden, ,

Site Contact

Nehara Begum, PD Dr.

[email protected]

+49 (0)511 39 60824

Klinikum Ulm, Ulm, Germany

Status

Recruiting

Address

Klinikum Ulm

Ulm, ,

Site Contact

Angelika Kestler, Dr.

[email protected]

+49 (0)511 39 60824

Universitätsklinik Würzburg, Würzburg, Germany

Status

Recruiting

Address

Universitätsklinik Würzburg

Würzburg, ,

Site Contact

Alexander Weich, Dr.

[email protected]

+49 (0)511 39 60824

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