Clinical Trial: Regorafenib in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Phase II Study of Regorafenib in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma
Brief Summary:
Regorafenib is an oral medication that can interfere with cancer cell growth and reduce the growth of blood vessels around tumors. This study will help find out if regorafenib is a useful drug for treating patients with adenoid cystic carcinomas. Regorafenib has been approved by the Food and Drug Administration (FDA) for use in other cancers, but remains an experimental drug that has not yet been approved for use in adenoid cystic carcinoma.
In this study, the patient will initially be treated with a dose of regorafenib that is lower than what the FDA approved for other cancers in an attempt to decrease the risk of side effects. It is possible that this lower starting dose may not be as effective as the higher FDA approved dose. If the patient does well with the lower dose for at least a month on treatment, the physician may consider increasing the dose to the FDA approved dose.
Detailed Summary:
Sponsor: Memorial Sloan Kettering Cancer Center
Current Primary Outcome:
- patients alive without disease progression [ Time Frame: 6 months ]by RECIST v1.1 criteria
- best overall response rate [ Time Frame: 6 months ](BOR = CR+PR) documented by RECIST v1.1 criteria
Original Primary Outcome: Same as current
Current Secondary Outcome: Safety [ Time Frame: 1 year ]
Original Secondary Outcome: Same as current
Information By: Memorial Sloan Kettering Cancer Center
Dates:
Date Received: March 24, 2014
Date Started: March 2014
Date Completion: March 2018
Last Updated: April 18, 2017
Last Verified: April 2017