Neuroendocrine TumorsPhase 2CABONENNCT04524208
A Trial of Cabozantinib in Patients With Advanced, Low Proliferative NEN G3
A Phase 2 study testing Cabozantinib in people with Neuroendocrine Tumors and Neuroendocrine Carcinoma, run by Karsten Gavenis at 15 sites in 2 countries.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors, Neuroendocrine Carcinoma
- What is being tested?
- Cabozantinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 1 Mar 2021to 31 Oct 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with histologically confirmed diagnosis of neuroendocrine neoplasia;
- Tumor proliferation rate has to be between Ki67 20% to 60% (local assessment);
- Male, female, or diverse patients aged > 18 years without upper age limit;
- At least one measurable tumor lesions in CT or MRI scan;
- Newly diagnosed or progressive disease assessed per RECIST criteria 1.1;
- Patients must have a performance status of ECOG 0-2;
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- Patients must have a life expectancy of more than 3 months;
- Hb> 9 mg/dl;
- platelets >80T/µl;
- white blood cells >3T/μL;
- total bilirubin <3mg/dl;
- AST and ALT <4xN;
- Serum creatinine <2mg/dl, eGFR >40mL/min/1.73m2;
- BUN <5xN;
- lipase <3xN;
- albumin ≥2.8 g/dL;
- PT/PTT ≤ 1.5 × ULN;
- urine protein: creatinine ratio ≤ 1;
- Written informed consent obtained according to international guidelines and local laws;
- Ability to understand the nature of the trial and the trial related procedures and to comply with them;
Who cannot join
- Patients younger than 18 years;
- Patients with Mixed Neuroendocrine-Non-neuroendocrine Neoplasia (MINEN);
- Patients with former treatment with TKI or VEGF receptor antagonist;
- Patients with additional malignancy <5 years in medical history (exclusion: non-invasive skin cancer);
- Patients with symptomatic brain metastases;
- Patients with Known HIV infection, infectious hepatitis (type A, B or C) or another uncontrolled infection;
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- Patients with Known hypersensitivity to Cabozantinib or contraindications for treatment with Cabozantinib according to Summary of Product Characteristics (SmPC);
- Patients with class III or IV congestive heart failure;
- Patients with QTc more than 500 ms or 140% of normal range according to age;
- Patients with uncontrolled hypertension;
- Patients with severely impaired lung function;
- Patients with history of organ transplant (exclusion: cornea transplantation);
- Patients with clinical apparent acute or chronic gastric ulceration;
- Patients with history of hemophilia;
- Patients with surgery at the GI tract within the last 12 weeks;
- Patients with patients with uncontrolled inflammatory bowel disease;
- Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed
- Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial;
- Previous participation in this trial
- concomitant use of therapeutic anticoagulation or strong CYP3A4 inducers or inhibitors (e.g. amiodarone);
- Known or persistent abuse of medication, drugs or alcohol;
- Person who is in a relationship of dependence/employment with the sponsor or the investigator;
- Patients who cannot give informed consent;
- Current or planned pregnancy, nursing period;
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
Germany14 sites
Zentralklinik Bad Berka GmbH
Bad Berka, 99437
Universitätsklinikum Carl Gustav Carus
Dresden, 01307
Universitätsklinikum Erlangen
Erlangen
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106
University Medical Center Göttingen
Göttingen, Lower Saxony, 37075
Universitätsklinikum Halle
Halle
Asklepios St. Georg
Hamburg
Medizinische Hochschule Hannover
Hanover
Klinikum Heidelberg
Heidelberg
Universitätsmedizin Mannheim
Mannheim
Universitätsklinikum Gießen und Marburg GmbH
Marburg, 35043
Johannes-Wesling-Klinikum Minden
Minden
Klinikum Ulm
Ulm
Universitätsklinik Würzburg
Würzburg
About this study
Official title: 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%.
- Conditions
- Neuroendocrine Tumors, Neuroendocrine Carcinoma
- Being tested
- Cabozantinib
- Medical subject headings
- Neuroendocrine Tumors, Carcinoma, Neuroendocrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabozantinibDrug
Cabozantinib is administered orally at the dose of 60 mg per day..
| Study group | Role | What they receive |
|---|---|---|
| Treatment-Arm | Experimental | Not described Receives: Drug: Cabozantinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efficacy of Cabozantinib treatment via DCR after 6 months.
Disease control rate (DCR) 6 months after treatment start .
Measured: 6 months
Secondary outcomes (6)
Evaluate short- and long term efficacy of Cabozantinib treatment via DCR.
DCR 3 and 12 months after treatment start.
Measured: 12 months
Evaluate short- and long term efficacy of Cabozantinib treatment via ORR.
Objective response rate (ORR) 3, 6 and 12 months after treatment start and best objective response rate.
Measured: 12 months
Evaluate short- and long term efficacy of Cabozantinib treatment via PFS.
Progression free survival (PFS).
Measured: 24 months
Evaluate short- and long term efficacy of Cabozantinib treatment via OS.
Overall survival (OS).
Measured: 24 months
Evaluate exposure time.
Time on drug (TOD).
Measured: 12 months
Assess quality-of-life during and after Cabozantinib treatment.
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.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start1 Mar 2021
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karsten Gavenis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Karsten Gavenis, University Medical Center Goettingen
- Investigators
- Alexander König, PD Dr., Principal investigator, University Medical Center Göttingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524208
- Sponsor's protocol ID
- 02679
- Acronym
- CABONEN
- Status last verified
- Aug 2024
- First submitted
- 18 Aug 2020
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CABONEN - A Phase II Trial of Cabozantinib in Patients With Advanced, Low Proliferative NEN G3
- ClinicalTrials.gov ID
- NCT04524208
- Acronym / sponsor ID
- CABONEN / 02679
- Conditions
- Neuroendocrine Tumors, Neuroendocrine Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Karsten GavenisUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 24 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment-Arm | Experimental | Drug: Cabozantinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patient with histologically confirmed diagnosis of neuroendocrine neoplasia;
- Tumor proliferation rate has to be between Ki67 20% to 60% (local assessment);
- Male, female, or diverse patients aged > 18 years without upper age limit;
- At least one measurable tumor lesions in CT or MRI scan;
- Newly diagnosed or progressive disease assessed per RECIST criteria 1.1;
Key exclusion criteria (24 listed)
- Patients younger than 18 years;
- Patients with Mixed Neuroendocrine-Non-neuroendocrine Neoplasia (MINEN);
- Patients with former treatment with TKI or VEGF receptor antagonist;
- Patients with additional malignancy <5 years in medical history (exclusion: non-invasive skin cancer);
- Patients with symptomatic brain metastases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CabozantinibCabozantinib is administered orally at the dose of 60 mg per day.. | Drug | Treatment-Arm |
Primary outcome
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 secondary outcomes
Evaluate short- and long term efficacy of Cabozantinib treatment via DCR.
Time frame: 12 months
Evaluate short- and long term efficacy of Cabozantinib treatment via ORR.
Time frame: 12 months
Evaluate short- and long term efficacy of Cabozantinib treatment via PFS.
Time frame: 24 months
Evaluate short- and long term efficacy of Cabozantinib treatment via OS.
Time frame: 24 months
Evaluate exposure time.
Time frame: 12 months
Assess quality-of-life during and after Cabozantinib treatment.
Time frame: 15 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander König, PD Dr. principal investigator
University Medical Center Göttingen
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cabozantinib in people with Neuroendocrine Tumors and Neuroendocrine Carcinoma, run by Karsten Gavenis at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the efficacy of Cabozantinib treatment via DCR after 6 months. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.