Cabozantinib in High Grade Neuroendocrine Neoplasms
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04412629|
Recruitment Status : Not yet recruiting
First Posted : June 2, 2020
Last Update Posted : June 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|High Grade Neuroendocrine Neoplasms||Drug: Cabozantinib Procedure: Blood for plasma biomarkers||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cabozantinib in High Grade Neuroendocrine Neoplasms|
|Estimated Study Start Date :||August 31, 2020|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||August 31, 2024|
-Cabozantinib 60 mg by mouth daily on days 1-21
Cabozantinib should be taken on an empty stomach (at least 1 hour before or 2 hours after eating) at the same time every day.
Other Name: Cabometyx
Procedure: Blood for plasma biomarkers
-Baseline (one day prior to the first dose of cabozantinib), after 1 week of treatment (range 5-8 days), after 2 weeks of treatment (range 12-15 days), and with every new cycle (every 21 days).
- Objective response rate (ORR) [ Time Frame: Through the end of treatment (estimated to be 4 months) ]
- ORR is defined as number of patients with complete response or partial response
- Complete response - Disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
- Partial response - At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
- Overall survival (OS) [ Time Frame: Through completion of follow-up (estimated to be 1 year) ]-OS is defined as days from date of treatment to date of death. Patients alive or lost to follow-up are censored at the follow-up date.
- Progression-free survival (PFS) [ Time Frame: Through completion of follow-up (estimated to be 1 year) ]
- PFS is defined as the days from the date of treatment and death or progression, which occurs first. Patients alive without progression or lost to follow-up are censored at the last follow-up date.
- Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
- Safety of regimen as measured by incidence of adverse events [ Time Frame: From start of treatment through 30 days after last dose of study treatment (estimated to be 5 months) ]
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): NCT04412629
|Contact: Nikolaos Trikalinos, M.D.||email@example.com|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Contact: Nikolaos Trikalinos, M.D. 314-362-5654 firstname.lastname@example.org|
|Principal Investigator: Nikolaos Trikalinos, M.D.|
|Sub-Investigator: Manik Amin, M.D.|
|Sub-Investigator: Benjamin R Tan, M.D.|
|Sub-Investigator: Esther Lu, M.S., Ph.D.|
|Sub-Investigator: Andrea Wang-Gillam, M.D., Ph.D.|
|Sub-Investigator: Rama Suresh, M.D.|
|Sub-Investigator: Katrina Pedersen, M.D.|
|Sub-Investigator: Nusayba Bagegni, M.D.|
|Sub-Investigator: Deyali Chatterjee, M.D.|
|Sub-Investigator: Ryan Fields, M.D.|
|Sub-Investigator: Chet Hammill, M.D.|
|Principal Investigator:||Nikolaos Trikalinos, M.D.||Washington University School of Medicine|