Clinical Trial: Dovitinib in Adenoid Cystic Carcinoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase II Study of TKI258 (Dovitinib) Monotherapy in Patients With Unresectable Adenoid Cystic Carcinoma

Brief Summary: The purpose of this phase II study of TKI258 (Dovitinib) in adenoid cystic carcinoma is to evaluate the efficacy of TKI258 (Dovitinib).

Detailed Summary: open, uncontrolled, multi-center, phase II study
Sponsor: Seoul National University Hospital

Current Primary Outcome: progression free survival [ Time Frame: 4 month ]

To determine 4month progression-free survival of TKI258 (Dovitinib) when administered as monotherapy in patients with unresectable adenoid cystic carcinoma


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • overall survival [ Time Frame: 2 years ]
  • response rate [ Time Frame: 8 weeks ]
    CT scan will be evaluated every 2 cycles (per 8 weeks)till progression. Reponse rate will be evaluated by RECIST criteria


Original Secondary Outcome: Same as current

Information By: Seoul National University Hospital

Dates:
Date Received: August 9, 2011
Date Started: September 2011
Date Completion:
Last Updated: November 11, 2014
Last Verified: November 2014