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

August 12, 2024 updated by: Karsten Gavenis

CABONEN - A Phase II Trial of Cabozantinib in Patients With Advanced, Low Proliferative NEN G3

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%.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Austria
      • Wien, Austria
        • Medizinische Universität Wien
  • Germany
      • Bad Berka, Germany, 99437
        • Zentralklinik Bad Berka GmbH
      • Dresden, Germany, 01307
        • Universitätsklinikum Carl Gustav Carus
      • Erlangen, Germany
        • Universitätsklinikum Erlangen
      • Freiburg, Germany, 79106
        • Universitätsklinikum Freiburg
      • Halle, Germany
        • Universitätsklinikum Halle
      • Hamburg, Germany
        • Asklepios St. Georg
      • Hannover, Germany
        • Medizinische Hochschule Hannover
      • Heidelberg, Germany
        • Klinikum Heidelberg
      • Mannheim, Germany
        • Universitätsmedizin Mannheim
      • Marburg, Germany, 35043
        • Universitätsklinikum Gießen und Marburg GmbH
      • Minden, Germany
        • Johannes-Wesling-Klinikum Minden
      • Ulm, Germany
        • Klinikum Ulm
      • Würzburg, Germany
        • Universitätsklinik Würzburg
    • Lower Saxony
      • Göttingen, Lower Saxony, Germany, 37075
        • University Medical Center Göttingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment-Arm
Drug: Cabozantinib
Cabozantinib is administered orally at the dose of 60 mg per day..

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluate the efficacy of Cabozantinib treatment via DCR after 6 months.
Time Frame: 6 months
Disease control rate (DCR) 6 months after treatment start .
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluate short- and long term efficacy of Cabozantinib treatment via DCR.
Time Frame: 12 months
DCR 3 and 12 months after treatment start.
12 months
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.
12 months
Evaluate short- and long term efficacy of Cabozantinib treatment via PFS.
Time Frame: 24 months
Progression free survival (PFS).
24 months
Evaluate short- and long term efficacy of Cabozantinib treatment via OS.
Time Frame: 24 months
Overall survival (OS).
24 months
Evaluate exposure time.
Time Frame: 12 months
Time on drug (TOD).
12 months
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.
15 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety of Cabozantinib via AE and SAE assessment.
Time Frame: 24 months
Adverse events and serious adverse events will be assessed in contingency tables.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karsten Gavenis

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alexander König, PD Dr., University Medical Center Göttingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 02679

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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