Clinical Trial: A Study of Apatinib in Metastatic Adenoid Cystic Carcinoma of the Head and Neck

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase II Study of Apatinib Mesylate Administered as a Daily Oral Treatment in Patients With Metastatic Adenoid Cystic Carcinoma of the Head and Neck

Brief Summary: This is a non-randomized, phase II, open label study of Apatinib Mesylate in patients with Head and neck metastatic adenoid cystic carcinoma (ACC). The primary purpose of this study is to evaluate the efficacy and safety of Apatinib Mesylate in patients with ACC.

Detailed Summary:
Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Current Primary Outcome: Progression-free survival(PFS) [ Time Frame: 6 months ]

To determine 6 month PFS of Apatinib Mesylate when administered as monotherapy in patients with metastatic adenoid cystic carcinoma


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall survival rate [ Time Frame: 2 years ]
    from date of enrollment until date of first death from any cause, assessed up to 2 years
  • Response rate [ Time Frame: 8 weeks ]
    CT scan will be evaluated every 2 cycles (per 8 weeks)till progression. Response rate will be evaluated by RECIST criteria
  • Number of participants with treatment-related adverse events as assessed by CTCAE v3.0 [ Time Frame: through study completion, an average of 2 years ]


Original Secondary Outcome: Same as current

Information By: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Dates:
Date Received: May 12, 2016
Date Started: June 2016
Date Completion: March 2019
Last Updated: September 30, 2016
Last Verified: September 2016