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 ]

Safety will be assessed in terms of AEs, laboratory data and vital sign data, which will be collected for all patients. Appropriate summaries of these data will be presented. AE will be listed individually per patient according to CTCAE version 4.0, and the number of patients experiencing each AE will be summarized. The safety population will comprise all patients who receive at least one dose of study treatment.


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