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
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors Neuroendocrine Carcinoma||Drug: Cabozantinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Cabozantinib is administered orally at the dose of 60 mg per day..
- Evaluate the efficacy of Cabozantinib treatment via DCR after 6 months. [ Time Frame: 6 months ]Disease control rate (DCR) 6 months after treatment start .
- Evaluate short- and long term efficacy of Cabozantinib treatment via DCR. [ Time Frame: 12 months ]DCR 3 and 12 months after treatment start.
- 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.
- Evaluate short- and long term efficacy of Cabozantinib treatment via PFS. [ Time Frame: 24 months ]Progression free survival (PFS).
- Evaluate short- and long term efficacy of Cabozantinib treatment via OS. [ Time Frame: 24 months ]Overall survival (OS).
- Evaluate exposure time. [ Time Frame: 12 months ]Time on drug (TOD).
- 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.
- Safety of Cabozantinib via AE and SAE assessment. [ Time Frame: 24 months ]Adverse events and serious adverse events will be assessed in contingency tables.
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
|Contact: Jessica Halfen, Dr.||+49 (0)511 39 email@example.com|
|Principal Investigator:||Alexander König, PD Dr.||University Medical Center Göttingen|